Unveiling Health and Healthcare Disparities in Non-Communicable and Chronic Diseases in Latin America: Setting the Stage for Better Health Outcomes Across the Hemisphere (R01 - Clinical Trials Not Allowed) is sponsored by National Institutes of Health (NIH). This Notice of Funding Opportunity (NOFO) supports innovative, collaborative, and interdisciplinary research focused on clinical epidemiology, evaluation of public and/or healthcare policies, and validation of measurements that address health and healthcare disparities related to non-communicable and chronic diseases (NCDs) with the highest disease burden and mortality in Latin America and among U.S. Hispanics/Latinos.

PAR-25-377: Unveiling Health and Healthcare Disparities in Non-Communicable and Chronic Diseases in Latin America: Setting the Stage for Better Health Outcomes Across the Hemisphere (R01 - Clinical Trials Not Allowed) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

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 Minority Health and Health Disparities ( NIMHD ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Nursing Research ( NINR ) National Cancer Institute ( NCI ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health ( ORWH ) Funding Opportunity Title Unveiling Health and Healthcare Disparities in Non-Communicable and Chronic Diseases in Latin America: Setting the Stage for Better Health Outcomes Across the Hemisphere (R01 - Clinical Trials Not Allowed) R01 Research Project Grant March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

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 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) 93. 307, 93.

866, 93. 361, 93. 313, 93.

121, 93. 393 Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) is being reissued in accordance with the simplified review criteria in effect for application due dates after January 25, 2025.

This Notice of Funding Opportunity (NOFO) will support innovative, collaborative, and interdisciplinary research focused on clinical epidemiology, evaluation of public and/or health care policies, and validation of measurements that address health and healthcare disparities related to non-communicable and chronic diseases (NCDs) with the highest disease burden and mortality in Latin America and among U.S. Hispanics/Latinos.

Funding Opportunity Goal(s) Objectives: Through R01-funded projects, this funding announcement aims at supporting innovative projects to enhance our understanding of social, behavioral, clinical and health services factors that can directly and demonstrably contribute to the improvement in minority health and the elimination of health disparities.

Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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).

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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Healthcare models refer to existing or newly proposed models of patient-centered care.

Examples of existing healthcare models include the Chronic Care Model, the eHealth Enhanced Chronic Care Model, the Community-Based Transition Model, the Nurse Management Model, the Home-Based Model, the Integrated Delivery Systems Model, the Patient-Centered Model, and the Value-Based Care Models, among others.

Multicomponent refers to frameworks with more than one component of a healthcare (e.g., healthcare system or organization, clinician decision support, clinical information system, patient self-management support, delivery system design). Multilevel refers to the multidimensional framework of determinants relevant to understanding minority health and addressing health disparities.

This concept is further described under the NIMHD Research Framework ( https://www. nimhd. nih.

gov/about/overview/research-framework/ ). Non-communicable and chronic diseases (NCDs) have been progressively recognized and studied in Latin America. There is notable variability in both NCDs prevalence and mortality across countries.

For instance, in 2019, 81% of all-cause fatalities throughout Latin America were associated with NCDs. For example, the prevalence of diabetes is increasing throughout the region, yet has been consistently higher in Mexico and Puerto Rico, where it is also one of the five leading causes of death.

Suicide and homicide are associated with a significant proportion of deaths throughout Latin America, while the burden of non-fatal interpersonal violence is also significant. COVID-19 broadly impacted Latin America, leaving behind strained healthcare systems and long-term consequences that are yet to be understood.

At the same time, multiple innovations have been emerging throughout Latin America that could impact the health of all Hispanic/Latino persons across the hemisphere and transcend to other populations. For example, significant breakthroughs in understanding mechanisms of premature onset Alzheimer’s disease (AD), clinical manifestations preceding AD and clinical phenotypes of AD in different Latin American countries have been emerging.

Insights on genetic ancestry, social determinants of health and risk for Type 2 diabetes, and pharmacogenomics and dosing of anticoagulation therapy have also been described.

Furthermore, the integration of various digital technologies into health care including cancer care, multidisciplinary diabetic foot care, management of diabetic retinopathy referral, and rapid assessment of retinopathy/blindness, innovative comprehensive diabetes care models (including enhanced diabetes self-management), and team-based primary care models have been successful in different settings. As of 2020, 62. 1 million (18.

9%) persons living in the U.S. 50 States self-identified as Hispanic/Latino. Despite the cumulative evidence supporting guidelines for prevention, diagnosis, and care for many non-communicable and chronic diseases (NCDs), the prevalence, and awareness, treatment, and control goals for these conditions among U.S. Hispanics/Latinos continues being unacceptably high and needs attention.

These facts also highlight the significant need for additional research on Hispanic/Latino health with a focus on effective prevention and models of healthcare. In addition to NCDs, interpersonal violence and suicide are among the top three leading causes of death among U.S. Hispanic/Latino persons aged 15-34 years.

In 2020, the previously documented longer life expectancy among the U.S. Hispanic/Latino population compared to White and Black or African American persons significantly narrowed because of the high mortality associated with COVID-19.

The landmark Hispanic Community Health Study/Study of Latinos (HCHS/SOL) was initiated in 2006 and has documented differences in the prevalence of health risk factors and NCDs among U.S. Hispanic/Latino persons from different heritage groups.

For example, a significantly higher prevalence of five cardiovascular risk factors and self-reported cardiovascular disease (CVD) among participants of Puerto Rican descent, and a greater prevalence of hypertension among Hispanic/Latino persons of Caribbean descent were reported compared to other Hispanic/Latino heritage populations in HCHS/SOL.

People of Puerto Rican descent had a greater risk of developing chronic kidney disease (CKD), and those of Mexican, Puerto Rican and Dominican descent had a higher prevalence of diabetes compared to other Hispanic/Latino heritage populations in HCHS/SOL.

In contrast, analyses at the population level have found that U.S. Hispanics/Latinos (as a group) have consistently lower all-cause, cardiovascular and cancer mortality compared to White and Black or African American persons. However, various studies have documented higher all-cause, cardiovascular and cancer mortality rates among U.S. Hispanic/Latino persons of Puerto Rican descent compared to those of Mexican or Cuban descent.

The U.S. Hispanic/Latino population is constituted by communities that have lived in the mainland long before it became the U.S., have immigrated to the U.S., or live in U.S. territories. Many U.S. Hispanics/Latinos maintain contact with their or their ancestors’ country of origin.

Considering the parallel similarities and differences between U.S. Hispanic/Latino groups and among Latin American countries, bold and strategic U.S. and Latin America collaborations have strong potential to improve health outcomes and the reduction of health disparities among these populations.

Therefore, the overarching goal of this NOFO is to support innovative and collaborative research on clinical epidemiology, evaluation of public and/or health care policies, and validation of measurements that address these pressing issues.

Such collaborations could uncover mechanisms or mediators of previously described differences among Latin American and U.S. Hispanic/Latino populations, and further the understanding of the sociocultural, environmental, clinical care/research and healthcare contexts that cannot be understood or identified through research conducted solely in the U.S. Furthermore, such research could eventually inform future interventions to promote timely prevention, diagnosis and care for persons with NCDs more effectively across the hemisphere.

This NOFO will support innovative, collaborative, and interdisciplinary research focused on clinical epidemiology, evaluation of public and/or health care policies, and validation of measurements that address health and health care disparities related to NCDs with the highest disease burden and mortality in Latin America and among U.S. Hispanics/Latinos.

Those NCDs include obesity, diabetes and related complications, cardiovascular and cerebrovascular diseases, hypertension, hypercholesterolemia/dyslipidemia, cancer, chronic lung disease (including asthma), chronic kidney disease, osteoarthritis, as well as chronic liver disease and cirrhosis.

In addition, sleep disordered breathing, cognitive impairment and dementia, geriatric conditions and longevity, and mental and behavioral health conditions have been increasingly studied in Hispanic/Latino persons in the U.S. and throughout Latin America, yet their diagnosis is often delayed.

Considering the significant incidence of both fatal and non-fatal interpersonal violence across Latin America and U.S. Hispanic/Latino communities, research in this topic is also of interest. Although most studies on NCDs have focused on adults, some studies have highlighted the increasing prevalence of children with chronic diseases and their unique needs. Therefore, children will be included in this initiative.

The initiative will support the analysis of existing health care datasets and health care systems to explore health disparities within the context of clinical/health services and/or health care systems. The evaluation of existing interventions integrated into health care and/or community settings and how health access is attained is of primary interest.

The evaluation and validation of clinical/health services epidemiology metrics and measurements. The evaluation of the impact of health care and/or public policies (e.g., policies addressing specific health risk factors outside the health care context, or sociopolitical policies that could impact funding and access to health care services) on community and/or patient health outcomes and health/health care disparities is a priority.

Such evaluation would inform research findings, and not advocate for specific policies. Studies that incorporate comparative analyses involving more than one Latin American country and/or of available data from U.S. Hispanic/Latino populations are also of interest.

Study methods could include retrospective and/or prospective data analyses (multi-component or multi-level), natural experiments, and mixed-methods studies, and other methods appropriate for the evaluation of clinical/health outcomes, interventions, health care systems, or policies. Projects will include studies conducted in Latin American countries where Spanish is the main language.

Studies performed in countries (including Puerto Rico) more highly represented in the U.S. Hispanic/Latino population will be prioritized. Puerto Rico would be considered both a U.S. territory and part of Latin America. Research teams are expected to include both U.S.-based and Latin America-based investigators; Puerto Rico-based teams are not required to include investigators from other U.S.-based institutions.

U.S.-based institutions -including Puerto Rico-will be the award recipients, but the proportion of the budget and research activities would be significantly larger for Latin America-based institutions (in the range of 30% to U.S.-based institutions and 70% to Latin America-based institutions), where the majority of the research is expected to be conducted.

Research teams are also expected to include at least one PI or MPI from institutions in Latin America.

The expectations regarding the research teams' composition are based on the ability and experience of local investigators to facilitate studies involving populations with whom they are acquainted in the geographic areas of interest, and who would have a better understanding of the health conditions, public health and healthcare needs, healthcare systems, or social determinants of health -including culture and language-in the locations where the studies will take place.

Collaborations (e.g., consultative, or subject-matter expert role) with investigators or research teams from Latin American countries with low representation in the U.S. Hispanic/Latino population are welcome.

Specific Areas of Interest include but are not limited to studies that: Explore and describe access to and utilization of health services, quality of care and associated clinical and health outcomes related to NCDs, especially among underserved populations including Indigenous, Afro-Latino, and rural and suburban communities.

Special focus on factors that mediate or facilitate clinical decision-making, factors that mediate, facilitate, or disrupt the patient-clinician communication/relationship, and the role and effectiveness of different health care system/model components on quality of care are of interest.

Explore and describe clinical disease phenotypes (for example, unusual or newly recognized clinical manifestations) of NCDs (e.g., diabetes, hypertension, cancer, heart failure, long COVID-19, asthma, chronic obstructive pulmonary disease, chronic kidney disease, liver disease, dementia, and other neurodegenerative disorders, and other chronic diseases), leading to more accurate and timely diagnoses, tailored and effective prevention and care and/or reducing health/health care disparities.

Explore the risk profile and burden of interpersonal violence on health, that could lead to potential interventions. Evaluate emerging lessons and best practices from existing primary care models and health care settings interventions on the optimal integration of guidelines of diagnosis and care for NCDs in primary care setting. Lessons and best practices based on location (e.g., urban, rural) and resources are of interest.

Evaluate interventions at the clinical (including clinical trials and patient-level interventions embedded within health care settings), health care system (healthcare models, policy change, interventions in health care system's components), or community level on the optimization of health outcomes (e.g., attaining recommended goals) and the reduction of health or health care disparities.

Evaluate the impact of health, healthcare and/or public policies (including policies in U.S. territories) on patient-level clinical outcomes (including risk factors), healthcare systems (including models of healthcare delivery), or population-level health outcomes. The validation and/or evaluation of metrics to assess impact are encouraged.

Comparisons across countries, and/or between different geographic locations (e.g., urban, suburban, rural) are also of interest. Assess the conceptualization of community and the contextualization of social determinants of health (SDoH) , and how these can be optimally integrated into community-engaged research and the assessment of health/health care disparities across the region.

Evaluate the effective integration of social services (e.g., food security, housing, education) with healthcare and its impact on health disparities and health outcomes. Assess the impact of interpersonal violence on collective mental health , and potential community-level interventions to reduce its impact on equitable health care access and optimal health care quality.

Explore the conceptualization of experiencing discrimination throughout Latin America and among U.S. Hispanics/Latinos , SDoH, health care and health outcomes to inform how to intervene to improve health outcomes. Evaluate interventions or policies that address discrimination of marginalized and underserved populations across the region and how they relate to health disparities and health outcomes.

Explore mechanisms underlying aging and age-related changes, resilience and protective health factors , and specifically related to mortality or longevity. Validate and/or evaluate metrics to better capture clinical/phenotypic data representative of populations to improve knowledge of health disparities and to inform policy interventions.

Explore strategies that strengthen relationships between evidence producers and decision makers , and the resulting impact of research findings on mitigating health disparities . Assess health care systems effective management of public health emergencies, disasters, and other humanitarian crises . Studies that assess community vulnerability and resilience to these events are also of interest.

Evaluate policies that integrate a holistic health approach that recognizes the interconnection between people and the planet, including Indigenous knowledge systems. Include comparative studies between communities in Latin America and U.S. Hispanics/Latinos on any of the research areas of interest described above.

Applications with the following attributes will be deemed non-responsive to this NOFO: Research that is exclusively qualitative. Studies exclusively focused on improvement on health outcomes without aiming at mitigating health disparities. Epidemiological studies that are exclusively population-based.

Studies not focused on NCDs. Studies in countries with low representation in the U.S. Hispanic/Latino population. Applications lacking key personnel from Latin America with substantial involvement and leadership in the research activities.

(Note: Applications must include at least one PI or MPI from a Latin America-based institution.) Studies in Latin American countries where Spanish is not the main language. Applications in which most of the work is performed by U.S.-based investigators.

Applications in which the proposed research team does not demonstrate strong partnerships (e.g., strong relationships with Latin American collaborators including policymakers, community workers and experts in implementation and others, as required in the proposed research strategy) Proposals focused on training/education/career development.

Annual Grantee Meetings : Awardees will be expected to participate in an annual investigators' meeting. These meetings will provide opportunities for sharing scientific findings from the funded projects and facilitate interactions between research teams and NIH program staff members with scientific and regional expertise.

Applicants should budget for the Principal Investigator(s) and at least one Latin America project member to attend the planned annual grantee meeting in person. Investigators teams (Latin American and U.S. collaborators) and NIH staff will be expected to participate in monthly teleconference calls or at other appropriate intervals.

They may also be expected to participate in collaborative working groups that meet periodically by teleconference call. Standardization and Coordination: Funded investigators will be expected to collaborate on and report key common variables in a standardized manner. Investigators may also be asked to collaborate in the development of formative tools, approaches to dissemination, and other areas of shared investigator interest.

Additionally, NIMHD will hold a pre-application informational webinar for this NOFO. Date, time, and other details will be posted at: https://www. nimhd.

nih. gov/news-events/conferences-events/ Information relevant to other specific Institutes/Centers/Offices: National Cancer Institute (NCI) NCI is committed to promoting health for all in cancer prevention, diagnosis, treatment, and survivorship for all populations. Cancer health disparities are in large part attributable to social determinants of health (SDOH).

However, the definitive knowledge of specific mechanisms through which SDOH shape cancer health disparities is limited, and effective strategies to mitigate harmful SDOH remain scarce.

For this NOFO, NCI is interested in proposals that apply innovative community-engaged research approaches to surface, synthesize and integrate lived experience to inform contextual understanding of key mechanisms of SDOH influence and to identify high leverage intervention opportunities to maximize potential impact for mitigating a given cancer health disparities in Latin America.

In the context of this NOFO, lived experience refers to the engagement of individuals who have a personal understanding of the sociocultural, socioeconomic, and political contexts through direct life experience and how this context may drive cancer health disparities.

” Lived experience provides unique insight into patterns, common behaviors, challenges, and barriers among individuals who share similar experiences providing a deeper understanding of contextual social issues. The NCI areas of interest include, but are not limited to: Integration of lived experience in new frameworks to conceptualize and surface key mechanisms of SDOH influence that represent intervention opportunities.

Integration of lived experience to test assumptions embedded in extant frameworks for conceptualizing and targeting the key mechanisms of SDOH influence. Novel methods and emerging strategies to measure and quantify lived experience across multiple contexts/sectors including changes over time. Innovative approaches to model complex, dynamic changes in lived experiences and their impact on SDOH causal web.

Develop and validate locally appropriate language to measure and define anthropological context (e.g., individualism vs. collectivism, sex egalitarianism, power distance) to enhance the understanding of context on SDOH causal webs.

Proposals should meaningfully engage communities experiencing health disparities in Latin America throughout the entire research process, including at the conceptualization, implementation, and evaluation stages. In addition, proposals should explicitly address the complex relationships between multiple SDOH drivers.

National Aging Institute (NIA) NIA promotes genetic, biological, clinical, behavioral, social, and economic research related to aging and life course health, including research on Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD).

A strategic priority of NIA is the understanding of health differences and development of strategies to improve the health status and well-being of older adult Hispanic populations in the United States and Latin America. NIA encourages comparisons between and within different countries in general aging and AD/ADRD outcomes.

NIA supports applications on the above-mentioned areas that are relevant to understanding processes of aging as they unfold over the life course or relevant to age-related diseases and health-related challenges experienced by midlife or older adults.

NIA has made substantial investments to encourage cross-national research to examine how different policy, institutional, environmental, economic, and social contexts lead to different later life outcomes, including those related to AD/ADRD.

NIA interests in this area include, but are not limited to, the following: Explore and describe access to and utilization of health services, quality of care and associated general aging and AD/ADRD outcomes, especially among underserved populations including Indigenous, Afro-Latino, and rural and suburban communities.

Compare and describe access to and utilization of health services, quality of care and associated general aging and AD/ADRD outcomes among Hispanic/Latino persons living in the United States, and countries in Latin America. Identify genetic risk and protective factors for AD/ADRD that impact disease trajectory. Fully reveal the genetic architecture of AD/ADRD in multiple race and ethnicity categories.

Determine whether cognitive/neuropsychiatric sequelae of SARS-CoV-2 infection place individuals at an increased risk of Alzheimer's disease or related dementias (ADRD). In addition to considering other theories, models and/or frameworks, resea r ch is encouraged to consider NIA’s Health Disparities Framework ( https://www. nia.

nih. gov/research/osp/framework ). In addition, the Health and Retirement Study (HRS) International Family of Studies provides nationally representative, longitudinal data for older people with multidisciplinary content for individual countries.

These studies are modeled after the HRS in the U.S. Several studies have been conducted in Latin America including Mexico ( Mexican Health and Aging Study (MHAS) , Puerto Rico and the Dominican Republic ( The Caribbean-American Dementia and Aging Study (CADAS), Brazil Brazilian Longitudinal Study (ELSI-Brazil), Costa Rica Costa Rican Longevity and Healthy Aging Study (CRELES).

The Harmonized Cognitive Assessment Protocol (HCAP) is a sub-study within the Health and Retirement Study (HRS) in the US and within some of the studies in the HRS International Family of Studies. The HCAP seeks to measure and understand dementia risk by collecting a carefully selected set of established cognitive and neuropsychological assessments and informant reports to better characterize cognitive function among older people.

HCAP data has been collected in two Latin American countries: Mexico ( Mexican Health and Aging Study: Cognitive Aging Ancillary Study (Mex-Cog)) and Chile ( Chile-Cog ) . The Gateway to Global Aging is a free public resource that facilitates cross-national analyses using this data.

NIA welcomes applications that propose cross-national analyses of HRS and/or HCAP data from the US and/or countries in Latin America or analysis of data from an individual Latin American country. Topics of interest include, but are not limited to: How do different health policy contexts influence later life health outcomes including those related to AD/ADRD among Hispanics/Latinos in the U.S. and Latin Americans?

How do different social contexts, including issues related to discrimination lead to different later life health outcomes among Hispanics/Latinos in the U.S. compared to their counterparts in Latin America? Are there protective factors that appear to improve later life outcomes for Hispanics/Latinos in the U.S. and/or their counterparts in Latin America?

What are the factors that affect the rate of aging across the lifespan, including those contributing to healthy or accelerated aging and/or prevention or slowing of common adverse age-related changes? National Institute of Nursing Research (NINR) NINR supports research to solve pressing health challenges and inform practice and policy - optimizing health and advancing health into the future.

NINR discovers solutions to health challenges through the lenses of social determinants of health, population and community health, prevention and health promotion, and systems and models of care.

Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses practice, including homes, schools, workplaces, clinics, justice settings, and the community. Observational, intervention, and implementation research are of interest.

Office of Research in Women's Health (ORWH) See Section VIII. Other Information for award authorities and regulations. Section II.

Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Application budgets are not limited but need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Organizations) 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. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility Applicant organizations may submit more