Part 1. Overview Information

Key Dates

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

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

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.



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

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 seeking to identify, develop, and test innovative strategies to address these health pressing issues, as well as to overcome barriers to the adoption, adaptation, scale-up, and sustainability of evidence-based guidelines for the prevention, diagnosis, and care for NCDs. Such collaborations could uncover mechanisms or mediators of previously documented 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 inform current and future interventions to promote timely prevention, diagnosis and care of persons with NCDs more effectively across the hemisphere.

Research Objectives

This NOFO will support innovative, collaborative, and multidisciplinary research focused on clinical, health services and/or community-based interventions that address health and healthcare 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, 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.

This NOFO will support research on interventions (especially multicomponent or multilevel interventions), encompassing community-based and health system-based interventions, quasi-experimental studies, and clinical trials (including cluster-randomized trials, pragmatic trials), and other research designs that address the health and healthcare disparities in primary prevention, and/or awareness, effective treatment, and control of NCDs across the region. Evaluation of interventions is of interest and can be included in the proposed scope of work.

Studies that explore barriers and facilitators to equitable access and utilization of health care services and patient retention across fragmented healthcare systems, and the delivery of interventions to overcome such barriers with adequate fidelity (i.e., delivered as intended) are of high interest. The development and testing of strategies to expand prevention and care of NCDs into community settings is also encouraged. Projects should also demonstrate the impact of these strategies and interventions on health outcomes and health/healthcare disparities. Studies that incorporate comparative analyses involving more than one Latin American country and/or U.S. Hispanic/Latino populations are welcome.

Projects will include studies conducted in Latin American countries where Spanish is the main language. Studies performed in countries more highly represented (including Puerto Rico) 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 and budget proportion are not based on race or ethnicity. These expectations 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 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 Research Areas of Interest include but are not limited to:

• Development and testing interventions -especially within the primary care setting-that optimize prevention, treatment effectiveness, improve patient self-management, and reduce preventable complications (including but not limited to hospital readmissions) associated with NCDs. The impact of these interventions on the reduction of health/healthcare disparities and advancing health equity is of interest.
• Development and testing innovative approaches on access and optimal continuity of care, quality of care, especially for underserved populations (e.g., Indigenous populations, older adults, rural communities, and Afro-Latino communities).
• Development and testing interventions that account for differences in clinical manifestation or clinical phenotypes of NCDs with the highest disease burden among Latin American communities and U.S. Hispanics/Latinos.
• Testing and evaluating interventions that strengthen the integration of effective care of NCDs into primary care through different healthcare models (including care coordination and community partnerships) and build resilient and sustainable healthcare systems.
• Development and testing innovative healthcare models that adapt and incorporate guidelines for the care of persons with multiple chronic conditions within the context of low resource settings, and underserved communities, including Indigenous populations, older adults, rural communities, and Afro-Latino communities. Models can combine clinical and/or community and/or home-based and/or health information/digital components and include assessment of equitable delivery of healthcare and attainment of health outcomes, reduction in health disparities, feasibility, and sustainability.
• Testing and evaluating interventions that address barriers, facilitators, and best practices regarding the implementation of health technologies at different levels of influence (e.g., individual, clinical/healthcare settings, social determinants of health, policies, infrastructure) or components within the healthcare system, and their impact on health/healthcare disparities.
• Development and testing home- and/or community-based strategies and/or community partnerships to optimize health promotion among medically underserved and low-resource populations. Studies that inform the best health promotion strategies for Indigenous and Afro-Latino populations, and other underserved communities are of interest.
• Development and testing interventions that address discrimination, racism, oppression, and mistreatment experienced by Indigenous, Afro-Latinos and other race/ethnic minority and underserved populations across the region and how they reduce disparities in access, utilization and quality of healthcare and increase equitable attainment of optimal health outcomes related to NCDs.

Applications with the following attributes will be deemed non-responsive to this NOFO:

• Research that is exclusively qualitative.
• Studies that do not address unique public health and/or health care needs related to NCDs with the highest burden and/or mortality in the country or countries of interest.
• Studies that implement care or an intervention on one chronic disease and propose testing the influence of that intervention on another chronic disease.
• Projects that prospectively test evidence-based interventions in understudied populations without modification to intervention content, delivery, or implementation.
• Studies focused on improvement on health outcomes without aiming at reaching health equity.
• Studies focused on exclusively identifying, describing and/or explaining health disparities in any given database or population.
• Studies not focused on NCDs.
• Studies in Latin American countries where Spanish is not the main language.
• 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.)
• 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 from diverse backgrounds 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 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.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

• U.S. Territory or Possession

Other

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

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Larissa Aviles-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 SF424 Application Guide and the Table of Page Limits must be followed.

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

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

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

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

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by 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.

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.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

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

Specific to this NOFO: Does the proposed project address unique public health and/or health care needs or disparities related to NCDs with the highest disease burden and mortality in Latin America and among U.S. Hispanics/Latinos?

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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 submitted in response to this NOFO. 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.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

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

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

Not Applicable

3. Data Management and Sharing

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

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

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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]

Larissa Aviles-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]

Liz Perruccio, MS, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-402-8084
Email: [email protected]

Damiya Eve Whitaker, PsyD, MA
ORWH - Office of Research on Women's Health
Phone: 301-451-8206
E-mail: [email protected]

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

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

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: [email protected]

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.