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 on Aging (NIA)

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)
Activity Code

R01 Research Project Grant

Announcement Type
Reissue of PAR-23-303
Related Notices
  • 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)
PAR-25-377
Companion Funding Opportunity
None
Number of Applications

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.

Key Dates

Posted Date
January 08, 2025
Open Date (Earliest Submission Date)
January 05, 2024
Letter of Intent Due Date(s)

Thirty (30) days before the application submission deadline.

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
February 05, 2025 * March 05, 2025 * May 07, 2025 * July 2025 October 2025 December 2025
June 05, 2025 * July 05, 2025 * September 07, 2025 * November 2025 January 2026 April 2026
October 05, 2025 * November 05, 2025 * January 07, 2026 * March 2026 May 2026 July 2026
February 05, 2026 * March 05, 2026 * May 07, 2026 * July 2026 October 2026 December 2026
June 05, 2026 * July 05, 2026 * September 07, 2026 * November 2026 January 2027 April 2027
October 05, 2026 * November 05, 2026 * January 07, 2027 * March 2027 May 2027 July 2027

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

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

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

Expiration Date
January 08, 2027
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Key Definitions

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/).

Background

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.

Research Objectives

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 equity is attained is of primary interest. The evaluation and validation of clinical/health services epidemiology metrics and measurements, especially focused on quality of clinical data from underrepresented groups, including Indigenous and Afro-Latino populations, and those living with low income and low resources are a priority. 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  also 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 race, ethnicity, and colorism throughout Latin America and among U.S. Hispanics/Latinos, and how it relates to racism and discrimination, SDoH, health care and health outcomes to inform how to intervene to improve health outcomes.
  • Evaluate interventions or policies that address discrimination, racism, oppression, and mistreatment experienced by Indigenous, Afro-Latino, and other 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 diverse populations, including Indigenous and Afro-Latino 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 health equity.
  • 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 focused on improvement on health outcomes without aiming at reaching health equity.
  • 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 and equitable 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 equity in cancer prevention, diagnosis, treatment, and survivorship for all populations. Cancer health inequities are in large part attributable to social determinants of health (SDOH). However, the definitive knowledge of specific mechanisms through which SDOH shape cancer health inequities 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 inequity 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, gender egalitarianism, power distance) to enhance the understanding of context on SDOH causal webs.
  • Proposals should meaningfully engage communities experiencing health inequities 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, research 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 structural racism, 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 equity into the future. NINR discovers solutions to health challenges through the lenses of health equity, 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)

ORWH is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH and is supported in the larger scientific community. To optimally improve population health, research, clinical interventions, and outreach communications must consider sex, gender, income, race and ethnicity, and geography and seek to ensure that high quality health tools, resources, therapies, etc. are acceptable and accessible to all. ORWH is interested in providing support for interdisciplinary, behavioral, clinical, and/or translational studies incorporating intersectional analyses, including women who are understudied, underrepresented, and underreported in research. Proposals seeking to understand where inequities exist and their impact on populations of women experiencing high rates of non-communicable chronic disease are of particular interest. Projects must align with at least one of the strategic goals and objectives outlined in the 2019-2023 Trans-NIH Strategic Plan for Women’s Health Research.

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

Section II. Award Information

Funding Instrument

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
New
Resubmission
Revision

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.

Clinical Trial?

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

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.

Award Budget
Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period

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

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized).

Federal Governments

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

Other

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

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference 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.

2. Cost Sharing

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

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Larissa Avilés-Santa, MD, MPH
Director, Division of Clinical and Health Services Research 
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-6924
Email: [email protected]

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

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

Research Strategy: Describe how the proposed activities at foreign sites will contribute to the knowledge that will improve minority health and/or help to reduce or eliminate health disparities in the United States.

Other Plan(s): 

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

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

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

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, 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 NIMHD Referral Office by email at [email protected] when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Requests of $500,000 or more for direct costs in any year 

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Mandatory Disclosure

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

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

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

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Scored Review Criteria

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

 

Significance

  • Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance.
  • Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study.

Innovation

  • Evaluate the extent to which innovation influences the importance of undertaking the proposed research. Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field.
  • Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.
 

Approach

  • Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).

Rigor:

  • Evaluate the potential to produce unbiased, reproducible, robust data.
  • Evaluate the rigor of experimental design and whether appropriate controls are in place.
  • Evaluate whether the sample size is sufficient and well-justified.
  • Assess the quality of the plans for analysis, interpretation, and reporting of results.
  • Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.
  • For applications involving human subjects or vertebrate animals, also evaluate:
    • the rigor of the intervention or study manipulation (if applicable to the study design).
    • whether outcome variables are justified.
    • whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.
    • whether the sample is appropriate and sufficiently diverse to address the proposed question(s).
  • For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

Feasibility:

  • Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work. For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances.
  • For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain an appropriately diverse population of participants. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, racial, ethnic, and sex or gender categories.
  • For clinical trial applications, evaluate whether the study timeline and milestones are feasible.

Specific to this NOFO:  Evaluate whether the applicant has described how the proposed activities at foreign sites will contribute to the knowledge that will improve minority health (and especially, Hispanic/Latino health) and/or help to reduce or eliminate health disparities in the United States.

 

Investigator(s)

Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.

Environment

Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.

Additional Review Criteria

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

 

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, 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, evaluate: 1) the justification for the exemption; 2) human subjects involvement and characteristics; and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

 

When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals 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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

 

When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.

 

As applicable, evaluate the full application as now presented.

 

As applicable, evaluate the progress made in the last funding period.

Not applicable. Renewals are not included in this funding announcement.

 

As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

 

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

 

Not Applicable

 

Evaluate 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 Center for Scientific Review, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

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

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

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

  1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
  2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Data Management and Sharing

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

4. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [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]

Scientific/Research Contact(s)

Larissa Avilés-Santa, MD, MPH
Director, Division of Clinical and Health Services Research
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-6924
Email: [email protected]

Frank Bandiera, Ph.D.
NATIONAL INSTITUTE ON AGING (NIA)
Phone: 301-496-3131
E-mail: [email protected]

Hiroko Iida, DDS, MPH
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-594-7404
E-mail: [email protected]

Randiak Alaro
National Cancer Institute (NCI)
Telephone: 240-660-1036
Email: [email protected]

Annina Catherine Burns, PhD, RD
ORWH - Office of Research on Women's Health
Phone: none
E-mail: [email protected]

Leigh A. Willis, PhD, MPH
National Institute of Nursing Research (NINR)
Telephone: 240-687-1634
Email: [email protected]
 

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Priscilla Grant, JD
Chief Grants Management Officer
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

Ryan Blakeney
NATIONAL INSTITUTE ON AGING (NIA)
Phone: 301-451-9802
E-mail: [email protected]

Gabriel Hidalgo, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-827-4630
E-mail: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Jenna Briggs
National Institute of Nursing Research (NINR)
Telephone: 301-480-0639
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.

Authority and Regulations

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

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