Part 1. Overview Information

Key Dates

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

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

No late applications will be accepted for this Funding Opportunity Announcement.

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

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

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Key Definitions for this Funding Opportunity Announcement (FOA)

• Minority Health Research The scientific investigation of distinctive health characteristics and attributes of minority racial and/or ethnic groups who are usually underrepresented in biomedical research to understand health outcomes in these populations.
• Racial minority groups include, American Indian or Alaska Native, Asian, Black or African American, and Native Hawaiian or other Pacific Islander.
• Ethnic y groups include, Latino or Hispanic.
• Health Disparities are health differences that adversely affect disadvantaged populations, such as racial and ethnic minority populations, less privileged socioeconomic status (SES) populations, underserved rural populations, sexual and gender minorities (SGM), and any subpopulations that can be characterized by two or more of these descriptions.
• Health Disparities Research consists of comparative studies examining differences in health care or health outcomes due to race, ethnicity, SES, geography, SGM. For this FOA, health disparities research may also focus on , age, and disability.

Terms related to minority health and health disparities follow guidelines of the Office of Management and Budget (OMB), and definitions from the National Institute on Minority Health and Health Disparities.

Background

Recent studies suggest that there are differences in genetic, neurobiological, neuropathological, and physiological factors associated with Alzheimer's disease (AD) and AD-related dementias (ADRD) among racial and ethnic minority groups. For example, studies have noted differences in AD/ADRD risk among APOE4 carriers of different ancestral backgrounds (e.g., elevated risk among Japanese compared to African-descent populations). Additionally, studies have noted that African Americans and Hispanic or Latino populations experience higher prevalence of co-morbidities (e.g., obesity, diabetes, and hypertension) that are associated with vascular contributions to cognitive impairment and dementia (VCID). Further, some studies have described differences in neuropathological features (e.g., mixed pathologies, silent infarcts, atrophy) and biomarkers (CSF t-tau, p-tau, amyloid) across varied populations.

Similarly, there are behavioral and social risk factors for AD/ADRD that appear to operate differently, or require additional characterization, across populations who have varied backgrounds and that have life experiences. For example, although low educational attainment remains a risk factor for AD/ADRD in African Americans, differences in educational quality moderate this relationship. There is also evidence that some neighborhood characteristics, such as opportunities for social engagement and population composition, may be protective against dementia in racial minority and underserved groups. A National Academies of Sciences, Engineering, and Medicine report encouraged research on several behavioral risk factors, including blood pressure management, cognitive training, and physical activity, for which there is “encouraging although inconclusive” evidence that targeting these behaviors holds promise for dementia prevention. However, very little evidence exists about the effectiveness of these and other potentially promising approaches, including dietary changes, improving sleep quality, and enhancing social engagement, in underrepresented populations.

While some progress has been made, many questions related to minority health and health disparities in AD/ADRD simply cannot be answered because of the severe lack of heterogeneity within available datasets. To address these knowledge gaps, we must increase the representation of individuals from understudied backgrounds in AD/ADRD research and establish sustainable, shareable, and heterogeneous data resources. This will also necessitate multi-disciplinary research teams to investigate minority health and health disparities in AD/ADRD, including investigations of the ways in which neurobiological and neuropathological processes intersect with environmental, sociocultural, behavioral, and other demographic factors to affect AD/ADRD risk, onset, detection and diagnosis, treatment recommendations, and clinical course. Additional research on the low AD/ADRD incidence and prevalence among some minority populations could offer insights into protective or resilience factors and may inform the development of intervention strategies to prevent or treat AD/ADRD.

Purpose

This FOA promotes collaborative research programs to support the development of research infrastructure (e.g., tools, surveys, biospecimens, data, etc.) for precision medicine approaches for minority health and health disparities in AD/ADRD. This FOA serves as a catalytic opportunity for investigators to: (1) focus on populations understudied in AD/ADRD research; (2) build resources that include neurobiological, environmental, behavioral, and social science data; and (3) initiate innovative, integrated, and expanded studies of individuals from these populations. Specifically, the National Institute on Aging (NIA) seeks to support Phase Innovation Awards Cooperative Agreement (UH2/UH3) projects to enable: (1) the formation of transformative, multi-disciplinary teams to address disparities in health outcomes, disease burden, and/or resilience among understudied populations with AD/ADRD; (2) the development, or scaling up, of research infrastructure and resources for studies of AD/ADRD in understudied populations; and (3) pilot projects that incorporate multi-level assessments and approaches to elucidate intersecting behavioral, social, environmental, neural, and physiological pathways affecting or mitigating AD/ADRD outcomes in these populations.

Research Objectives and Requirements

Research projects should be conceptualized within NIA’s Health Disparities Framework, which outlines four key levels of analysis related to disparities research–environmental, sociocultural, behavioral, and biological. Within these levels, the framework highlights important factors for minority health and health disparities research related to healthy aging and AD/ADRD.

Projects that focus on either health disparities or minority health are both responsive to this FOA. The proposed research may focus on single or multiple, understudied populations, or population subgroups. It is envisioned that this initiative will launch multi-disciplinary teams with expertise in neuroscience and behavioral/social science, give rise to rigorous methodologies for minority health and health disparities research, and increase the number of understudied populations in AD/ADRD studies. The objective is to bridge neuroscience with behavioral and social science through the creation and/or use of data sources to be shared with the scientific community. These activities are expected to inform future preventative, therapeutic, and intervention strategies for understudied populations.

There are special concerns, including trust and data ownership, when conducting research on health disparities or in minority populations. To correct for the long-standing lack of inclusive recruitment and retention for AD/ADRD research, and to lay the foundation for sustained partnerships with affected communities, all projects, regardless of scientific aims, must propose and budget for meaningful engagement with relevant stakeholders throughout the research process (e.g., https://www.pcori.org/engagement/value-engagement). Community engagement activities can inform research questions, enhance recruitment and retention efforts, facilitate the collection of data and biospecimens, facilitate the development of culturally appropriate research tools, and promote dissemination of results to community stakeholders.

UH2/UH3 ACTIVITY CODE

This FOA utilizes the UH2/UH3 activity code. The UH2 Exploratory/Developmental Phase will be for two years, and the UH3 Implementation Phase will be for three years.

UH2 Exploratory/Developmental Phase

Aims of the UH2 phase should include:

1. The formation and/or solidification of multi-disciplinary teams with experience in minority health and/or health disparities research, as well as AD/ADRD expertise. Teams should include members who will advance integrative research that spans neuroscience and behavioral and social science. As appropriate to the research proposed, teams are encouraged to include expertise in measurement of AD/ADRD-relevant risk factors, including social determinants of health and other aspects of the “exposome”; genetic or environmental epidemiology; cell and molecular sciences; engineering; behavioral measurement and neuropsychological assessments of cognition and other functional abilities; and the clinical symptoms and neuropathological signs associated with cognitive decline, mild cognitive impairment, and AD/ADRD.
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 and resources for integrative studies of AD/ADRD in understudied populations. The resulting infrastructure or resources must ensure sufficient variation on relevant demographic and life history characteristics as appropriate to the scientific focus of the application. Approaches include, but are not limited to, the following:

• The development and/or testing of new measures, tools and/or methods for recruitment, retention, and data collection from well-defined populations;
• 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 of minorities and/or understudied populations;
• The development of a sampling frame for a new population-representative studies for subsequent implementation in full-scale research on AD/ADRD.

4. Meaningful engagement of relevant stakeholders. The partnership between the research scientists and the community partners is expected to draw upon each of their respective strengths, allowing for the integration of their unique perspectives and expertise into informing research priorities. The partnership should also facilitate bi-directional communication between researchers and the engaged community over the course of the research study. Types of community partners 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. A comprehensive Data Sharing Plan.
6. Applicants are encouraged to leverage existing NIA-supported infrastructure, such as the following:
   • Data Resources for Behavioral and Social Research on Aging,
   •  Alzheimer’s Disease Research Centers, 
   • Alzheimer’s Disease Sequencing Project,
   • NIA’s Genetics of Alzheimer's Disease Data,
   • AD-Focused Resource Centers for Minority Aging Research, and
   • Centers on the Demography and Economics of Alzheimer’s Disease and Related Dementias, Behavioral and Social Research Networks.

UH3 Implementation Phase will support adequately powered pilot projects to investigate the intersecting genetic, behavioral, social, environmental, neural, and physiological pathways affecting minority health and health disparities in AD/ADRD, and to lay the foundation for future, larger scale projects.

Activities proposed should seek to advance understanding of causal pathways that promote or protect against AD/ADRD in minority and understudied populations. During the UH3 phase, investigators should do the following:

1. Utilize data collected or collated during UH2 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 multilevel preliminary data to support future, larger scale research projects on minority health and health disparities in AD/ADRD.

Specific Areas of Interest

Investigators should propose studies that advance understanding of cognitive functioning and AD/ADRD across well-characterized heterogenous populations, include both AD/ADRD neural biomarkers and rich behavioral or social assessments, and have the potential to inform our understanding of causal pathways accounting for differences in minority health or driving AD/ADRD health disparities.

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 that examine cognitive, neuropathological and/or neurobiological consequences from early life adversity, experiences of discrimination, and/or structural racism.
• Studies that examine the association of cognitive function and AD/ADRD biomarkers in relation to the built, social and physical environment, behavioral and psychological phenotypes, and genetics.
• Studies that examine functional biological pathways within the context of gene–environment interaction and risk of or resilience to AD/ADRD.

Data types to collect, collate, and/or analyze include, but are not limited to, the following:

• 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); and mental health history.
• Demographic: Race, ethnicity, gender, sex, immigration status, socioeconomic status, education, and geography.
• 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.

Milestones and Timelines

The application must include well-defined milestones and timelines for assessing progress in both the UH2 and UH3 phases, including specific milestones for progressing from the UH2 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 UH2 grant is awarded, and will be included in the terms and conditions of the UH2 Notice of Award (NoA). Successful completion of UH2 milestones is required to transition to the UH3 award.

To initiate the transition from the UH2 phase to 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 UH2 funding for the UH2/UH3 cooperative agreement does not guarantee support of the UH3 phase.

Annual Investigator Meeting

Investigators are expected to participate in an annual Program Director/Principal Investigator (PD/PI) meeting. The meeting will be held in the Bethesda, Maryland area and will start after the first NoA.  The meeting is expected to last for 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.

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 foreign populations
• Applications that do not include all of the following components:

• Plans to increase or improve inclusion of populations understudied in AD/ADRD research
• Plans to develop or improve measures, sustainable databases, or other resources for the study of AD/ADRD minority health and/or health disparities, as defined in the NIA Health Disparities Framework

• A multi-level approach: inclusion and integration across neurobiological, behavioral, sociocultural, and environmental data
• A plan for appropriate and meaningful community engagement

• A description of milestones, performance metrics, and a timeline for completion of milestones

Frequently Asked Questions

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

Resources for Applicants

• NIA Health Disparities Framework
• NIH Strategic Plan for Data Science
• NIA Guidance on Sharing Data and Other Resources
• NIH Scientific Workforce Diversity Office

• Enhancing the Diversity of the NIH-Funded Workforce (Diversity Program Consortium) (DPC)
• Information regarding engagement in research

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 FOA.

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 Government

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Applicant Organizations

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

• System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and 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 his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Damali Martin, Ph.D., MPH
Telephone: 301-402-8310
Email: [email protected]

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

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

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

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

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

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

The PD(s)/PI(s) should have demonstrated accomplishment in effectively leading multidisciplinary teams. If the application is multi-PD/PI, investigators should have complementary and integrated expertise and skills in order to provide an appropriate leadership approach, governance, plans for conflict resolution, and organizational structure applicable to the study. The applicant(s) should have experience overseeing selection and management of sub awards, if needed.

R&R Budget

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

Investigators are expected to participate in an annual Program Director/Principal Investigator (PD/PI) meeting. The meeting will be held in the Bethesda, Maryland area and will start after the first NoA.  The meeting is expected to last for 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 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 annual meeting in their yearly budget.

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

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

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

Specific Aims: Provide the overall goal for the entire proposal and indicate separately the Specific Aims to be accomplished in the UH2 Exploratory/Developmental phase and UH3 Implementation Phase.

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.
• Justify and explain rationale for selection of the study population/geographic regions.
• Describe how the research is conceptualized or aligned with the NIA Health Disparities Research Framework and to what extent.
• Describe how the design and data collected will advance the understanding of the causal pathways that promote, or protect against, AD/ADRD in minority and understudied populations.
• 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 for understudied populations in the United States.

Sub-section B. Multi-disciplinary Team

• Provide a rationale and a justification for choosing the scientific team. In the justification, outline the individual team members areas of expertise, including their expertise in neuroscience and social/behavioral science, and ways in which team members complement each other for the benefit of the project.
• 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 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 critical factors in minority health and health disparities
• Specify how the study participants represent understudied populations and/or facilitate health disparities research, per definitions provided in Section I. Funding Opportunity Description.
• 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 validity and reproducibility.

Sub-section D. Approach (may be divided into the UH2 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 allow the integration (current or future) of neuroscience with genetic/biological/-omics, environmental, behavioral, and social science to advance understanding of the causal pathways that promote or protect against AD/ADRD in minority and understudied populations.
• 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 infrastructure created and data collected will support a precision medicine approach for future preventative or therapeutic intervention strategies development.

Sub-section E. Milestones and Timelines

The application must include well-defined milestones and timelines for assessing progress in both the UH2 and UH3 phases, including specific milestones for progressing from the UH2 phase to the UH3 phase. A timeline, with milestones incorporated, is required for the UH2 Exploratory/Developmental Phase and the UH3 Implementation Phase. The timeline and milestones should reflect 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 UH2 and UH3 stage must be provided in a separate heading at the end of the Approach section and should:

• 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 UH2 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
• 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.

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.

  In keeping with NIA’s strategic goal to enable and promote open science practices and Findable, Accessible, Interoperable, and Reusable (FAIR) data practices, and the NIA/NIH goal to enhance transparent reporting and increase research rigor and reproducibility, awardees will be expected to make all data, analytical methods, and research tools available to the broad scientific community through NIH-designated data repositories, and/or open-source/open-access platforms adopting the FAIR principles. Applications will need to provide a timeline for data generation, tools development, and data deposition as part of a complete Data Sharing Plan. Program staff may negotiate modifications to the plan prior to funding. Applicants should include appropriate support for annotation and curation of data types used and/or generated on the project to maximize the usability of the data by the broader research community. For more information and NIH Data Sharing Policy, please review the Final NIH Policy for Data Management and Sharing.

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.

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.

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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.

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 fieldof 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 FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

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

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

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.

Significance

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?

RFA-Specific Questions: Is the project conceptualization aligned with the NIA Health Disparities Research Framework? Will this proposal increase the number of understudied populations in one or more AD/ADRD studies? Does the project address the need for development and/or testing of new tools or new methods for recruitment, retention, and data collection from understudied populations? Do the design and data collected address the need to advance understanding of the causal pathways that promote or protect against AD/ADRD in minority and understudied populations? To what extent will resources created allow the integration of neurobiological, genetic/genomic, environmental, behavioral and social science data? To what extent will the resources created serve to improve or expand research on minority health or health disparities in people living with AD/ADRD?

Investigator(s)

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?

RFA-Specific Questions: Does the senior PI demonstrate an ongoing record of effectively leading multi-disciplinary teams? Does the research team include expertise in both neuroscience and social/behavioral science? Does the research team include expertise 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 particular understudied populations, does the team include expertise with those populations and experience engaging relevant community partners?

Innovation

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?

Will the infrastructure created, and data collected allow for novel and/or expanded investigations of critical factors in minority health and health disparities?

Approach

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?

RFA-Specific Questions: Will the infrastructure created and/or data collected support a precision medicine approach for future preventative or therapeutic intervention strategies development? Are the methods proposed state-of-the-art and culturally appropriate for the populations of interest? Does the approach address potential challenges in recruitment, retention, and/or measurement? Are the activities proposed for community engagement culturally appropriate, robust, and likely to be sustained across the entire project period? Do the activities and research proposed integrate (or allow integration of) neuroscience with genetic/biological/-omics, environmental, behavioral, and social science to advance understanding of the causal pathways that promote or protect against AD/ADRD in minority and understudied populations? Is the collection of multiple types of data proposed? To what extent does the project seek to leverage existing infrastructure/resources?

Reviewers will comment on whether the Data Sharing Plan is reasonable. How adequate are the applicant's plans to share, organize, and store resources and data? 

Environment

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?

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.

UH2/UH3 Milestones: How clearly are the steps and milestones defined? Are the milestones feasible and quantifiable with respect to proposed objectives? Are adequate criteria provided for the UH2 Exploratory/Developmental Phase to determine the successful completion of milestones? How appropriate are the milestones for the UH3 Implementation Phase?

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Vertebrate Animals

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 Animal Section.

Biohazards

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.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

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.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Sharing Model Organisms; and (2)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

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 FOA.

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

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

3. Anticipated Announcement and Award Dates

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

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

Section 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.5. 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 FOA 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:

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees 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 UH2/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 coauthorship, 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 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 sharing policies for NIH.
• Designating investigators to serve as members on 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 Project Scientist will interact scientifically with the research team and provide input, expert advice, and suggestions in 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 in management and technical performance.
• The NIA 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 transition from UH2 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 transition from UH2 to UH3 phases.
• 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 UH2/UH3 project, consisting of the leadership of the UH2/UH3 project and NIA staff (one voting member).
  • The Steering Committee will be chaired by one of the UH2/UH3 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 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 in scientific or programmatic matters (within the scope of the award) between award recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient.This special dispute resolution procedure does not alter the awardee'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. 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 FOAs 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 $25,000.  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, 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 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

Finding Help Online: http://grants.nih.gov/support/ (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]

Damali Martin, Ph.D., MPH
Division of Neuroscience
National Institute on Aging
Telephone: 301-402-8310
Email: [email protected]

Janine M. Simmons, M.D., Ph.D.
Division of Behavioral and Social Research
National Institute on Aging
Telephone: 301-529-7254
Email: [email protected]

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

Jeni Smits
National Institute on Aging (NIA)
Email: [email protected]

Section VIII. Other Information

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

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