It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. 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

The NIH Institutes participating in this FOA have a strong interest in understanding and improving the health of immigrant populations that constitute health disparity populations in the US (racial/ethnic minorities, socioeconomically disadvantaged populations, sexual and gender minorities, and underserved rural populations). Part of this understanding involves considering the determinants of health in the native countries of immigrants that shape their health status in the US, such as environmental exposures, sociocultural factors, health beliefs and behaviors, and nature of and interaction with formal and informal health care systems. A number of informative studies in the published literature have examined health care, health behaviors, and health outcomes in the US compared to the native country for populations of Latin American (particularly Mexican) and Asian origin. Although some studies on populations from Latin America have included Caribbean Latinos, far less research has focused on such comparisons among individuals of Caribbean origin, despite the fact that the Caribbean region accounts for the largest number of immigrants to the US from health disparity populations after Mexico, Central America and East Asia. Further, research often folds Caribbean-origin populations into larger groups (e.g., Caribbean origin populations as a whole, African Americans, Hispanics/Latinos) rather than examining populations according to Caribbean country of origin, or by race/ethnicity within the Caribbean region, potentially obscuring important variations within and across individual countries in the Caribbean region.

At the population level, it is evident that chronic disease prevalence and mortality are increasing in the Caribbean region. However, small and often non-representative samples make it challenging to discern consistent patterns of disease risk and prevalence within the Caribbean region and/or to make comparisons with Caribbean-origin individuals in the US. In some studies, individuals living in the Caribbean have a higher prevalence of diseases such as diabetes, asthma, and breast cancer than Caribbean immigrants or African Americans in the US, while other studies find the opposite pattern. In addition, much of the research with Caribbean populations has focused on individuals of African-descent and/or English-speaking populations. There is relatively less research on Spanish- or French-speaking populations in the Caribbean, although available data indicate a lower prevalence of chronic disease in these groups with exception of Haitian populations.

The purpose of this initiative is to support research that develops or extends cohort or surveillance studies to better understand health of populations in Caribbean countries, to enable these cohorts to be used in comparative research to better understand the health of Caribbean immigrants in the US. The focus of research for this FOA is chronic diseases, such as cardiovascular disease, selected cancers, diabetes, chronic respiratory disease, chronic liver disease, chronic inflammatory conditions, arthritis, and HIV/AIDS, as they are the predominant causes of premature morbidity and mortality in both the US and the Caribbean region. An additional purpose of this FOA is to foster partnerships between US-based and Caribbean-based researchers to conduct collaborative research on chronic disease in both locations. The ultimate goal of this initiative is to generate knowledge that can inform preventive, treatment, and policy interventions to improve chronic disease outcomes of individuals of Caribbean descent in the Caribbean and the US.

This FOA uses the United Nations world and regional groupings to identify countries that fall within the Caribbean region (see listing at http://mdgs.un.org/unsd/mdg/Host.aspx?Content=Data/Regional/latin.htm). For the purposes of this FOA, Puerto Rico and the US Virgin Islands, as US territories located within the Caribbean region, are considered as both US and Caribbean sites. Projects involving US-Cuba research collaborations are encouraged. However, NIH can only support US-based or other Caribbean institutions or individuals for such US-Cuba collaborations. Support for institutions and individuals in Cuba must be provided through non-NIH sources.

Research supported under this FOA will establish or extend cohort studies in the Caribbean that can be used for both ongoing population health research in the Caribbean region and future comparative research with US populations. Cohorts that have the potential to be continued after the NIH funding period, for example, that can be supported by governmental or other organizations within the Caribbean region, are strongly encouraged. Possible projects may involve one or more of the following approaches:

• The establishment of a cohort study that may be followed longitudinally.
• The establishment of datasets derived from electronic health records to create a retrospective cohort and facilitate prospective follow-up.
• To establish datasets from ongoing surveillance efforts by health departments or other organizations that are independent samples.
• The addition of new measures or data elements to existing or ongoing cohort studies to better align with US datasets.
• The collection of an additional wave of data collection for existing longitudinal cohort studies.

In addition to establishing or extending cohort or surveillance studies, the project is expected to conduct analyses related to population health in the Caribbean using the cohort data. Research teams that already have existing datasets that require little or no modifications or additions to use for comparison with US data sets may propose such comparisons. However, because the intent of this initiative is to build the foundation for future US-Caribbean comparative research, comparative analyses are not a requirement for this FOA. Primary data collection is limited to sites in the Caribbean.

In order to support future comparative analyses, Caribbean-based data collection is expected to be aligned with data from publicly available datasets on US populations, particularly those that include representation from Caribbean immigrants or US-born individuals of Caribbean descent. Examples of such data sets include but are not limited to those identified in the National Partnership for Action to End Health Disparities (NPA) Federal Interagency Health Equity Team (FIHET) "Compendium of Publicly Available Datasets and Other Data-Related Resources" (see https://www.minorityhealth.hhs.gov/NPA/Materials/FIHET_Data_Compendium_508_version_FINAL_11_28_2016.pdf)).

Potential research topics for examination in the current project as well as for future comparative analysis may include but are not limited to the following:

The incidence/prevalence of chronic disease and of risk factors for these conditions.

• Genetic, biological, social, and environmental determinants of chronic disease outcomes.
• Reasons for of populations who experience better than expected health outcomes (e.g., lower prevalence, morbidity, or mortality related to chronic disease) despite social, economic, or environmental disadvantage.
• Type, intensity, and quality of healthcare received for chronic conditions and diseases.
• Help-seeking patterns and barriers regarding formal healthcare as well as integrative or indigenous medicine.

Research teams are expected to include both US- and Caribbean-based investigators. It is expected that Caribbean-based investigators will assume primary responsibility for the design of and data collection for the Caribbean cohort, while US-based investigators are expected to identify appropriate US datasets that the Caribbean cohort will be aligned with, and, if relevant, to provide scientific expertise and technical assistance to less research-intensive Caribbean institutions to successfully execute research activities. Given that the bulk of research activities will take place in the Caribbean, it is expected that at least 60% of direct costs will be directed to Caribbean-based institutions and personnel.

Areas of specific interest include but are not limited to the following:

• Data collection in Caribbean countries/US territories that have the highest levels of immigration to the mainland US, including Cuba, Puerto Rico, the Dominican Republic, Haiti, and Jamaica, as well as other Low and Middle Income countries or US territories (see listing of Caribbean countries by World Bank income group: http://mdgs.un.org/unsd/mdg/Host.aspx?Content=Data/Regional/latin.htm).
• Data collection at multiple sites to allow for examination of chronic disease across countries or language groups (i.e., English-, Spanish, or French-speaking).

In addition, different Institutes and Centers at NIH are interested to support research in the following specific areas:

The National Institute on Minority Health and Health Disparities (NIMHD) is interested in projects that examine the impact of different determinants (biological, behavioral, socio-cultural, environmental, physical environment, health system) at multiple levels (i.e., individual, interpersonal, community, societal) on health outcomes in Caribbean populations (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for examples of health determinants of interest). Health conditions of particular interest include but are not limited to diabetes, chronic kidney disease, osteoarthritis/inflammatory arthritis, and HIV/AIDS, as well as behavioral risk factors (diet, physical activity, tobacco use, alcohol and substance use) that are relevant to multiple chronic diseases.

The National Cancer Institute (NCI) coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. Projects that align to cancer-related data sets like Surveillance, Epidemiology, and End Results (SEER) and The National Health and Nutrition Examination Survey (NHANES) in addition to the Federal Interagency Health Equity Team data-related resources are of interest to the NCI. Research that investigates disparities along the cancer continuum (prevention, detection, diagnosis, treatment and survivorship) are of interest to the NCI.

The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership for a research, research training, and education program to promote the prevention and treatment of heart, lung, blood, and sleep diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI encourages research designed to answer the breadth of scientific questions related to heart, lung, blood, and/or sleep diseases, disorders, and phenotypes. The NHLBI seeks applications that will address questions relevant to the NHLBI mission, address gaps in the NHLBI's portfolio of clinical and epidemiology cohort studies, and should align with the NHLBI's Strategic Vision. NHLBI's strategic priorities emphasize the continuum of research from basic molecular biology research to implementation science related to heart, lung, blood diseases and sleep disorders (e.g. Sickle Cell Disease and other hemoglobinopathies; cardiovascular diseases; hypertension prevention and control; asthma; chronic obstructive pulmonary disease (COPD), sleep apnea; and other cardiopulmonary diseases and conditions), self-management of symptoms and disease conditions, and prevention of these diseases and disorders in various populations. The NHLBI also has significant interests in implementation science research for the prevention, control, and treatment of heart, lung, blood diseases and sleep disorders, particularly research that addresses the development of interventions or strategies that address the translation of proven effective evidence-based interventions into clinical, community, and/or other settings; addresses impediments to uptake, scale up, and sustainability of evidence-based interventions in various contexts; and/or examines disparities is disease burden, models possible treatment paradigms, and/or proposes interventions in small island developing states. Through this funding opportunity announcement, the NHLBI encourages research that will investigate innovative hypotheses, as well as innovative research; as such, applications should propose studies investigating hypotheses not addressable in the large cohort studies currently funded by the NHLBI. Please refer to the NHLBI website for more details on the research priorities of the NHLBI: https://www.nhlbi.nih.gov/about/documents/strategic-vision.

The National Institute on Aging (NIA) is especially interested in applications for studies that would

• Incorporate study designs and content useful for comparative studies of cognitive decline and assessment of dementia;
• Employ designs and content useful for comparative studies of the antecedents, treatment and trajectories of multimorbidity at older ages;
• Make use of methods and variable definitions that are harmonized to the extent possible to measures used in other NIA-funded longitudinal studies, such as the Health and Retirement Study, Midlife in the United States, and the National Health and Aging Trends Study. The website Gateway to Global Aging Data provides a concordance: https://g2aging.org/, and many data resources can be reached through the National Archive of Computerized Data on Aging: http://www.icpsr.umich.edu/icpsrweb/NACDA/.

The mission of the National Institute of Nursing Research (NINR) is to promote and improve the health and quality of life of individuals, families, and communities. Of relevance to this FOA is that nursing science transcends the boundaries of illnesses and research disciplines to better understand the experiences of individuals and families living with illnesses and to develop personalized approaches that maximize health and well-being, reduce symptoms, and promote self-management for individuals at all stages of life, across diverse populations and settings. Additional information on NINR's research interests and focus can be found at http://www.ninr.nih.gov/AboutNINR/NINRMissionandStrategicPlan.

Specific topics of interest to the NINR include, but are not limited to:

• Studies designed to assess behavioral, biological and genomic risk factors of chronic illnesses (e.g., genetic markers, diet, physical activity, lifestyle) in Caribbean populations
• Research on the barriers to and/or factors facilitating self-management of chronic illnesses (e.g., socioeconomic status, family and/or caregiver support, environmental determinants) in Caribbean populations
• Secondary data analysis of existing datasets: 1) to improve understanding of symptom assessment, symptom management, and/or symptom advancement associated with chronic illnesses in Caribbean populations and 2) to discover biological, clinical, psychosocial, behavioral and economic factors related to symptom burden experienced by Caribbean populations with chronic illnesses
• Research on understanding the biological, physiological, environmental and behavioral issues in relation to women's health and wellness in Caribbean populations

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

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

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)

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)
• 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 Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF424 (R&R) Application Guide.

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

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. 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 NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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

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

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

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

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

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

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

The budget allocation to institutions (as the application organization or through consortia) and personnel (through consortia or consultant agreements) outside of the Caribbean region should not exceed 40% of annual direct costs.

For projects involving US-Cuba research collaborations, support for institutions and individuals in Cuba are not permitted and must be provided by non-NIH sources.

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

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

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

Research Strategy: Identify and delineate the roles of US-based and Caribbean-based investigators and other collaborators, including the provision of technical support to investigators from non-research intensive institutions in the Caribbean as well as plans for ensuring equitable partnerships and shared decision-making across collaborators. Include communication plans for coordination between Caribbean and US partners, capabilities for sharing information and methods for transferring information and data. Describe how the Caribbean-based data that have been or will be collected are aligned with and can be compared with data from publicly available datasets on US populations. Identify research questions of relevance to individuals of Caribbean descent in the US or the Caribbean that can be addressed in the current project and/or in future research. Describe the plan for analyzing Caribbean-based data in the current project. Describe how the collection and analysis of Caribbean-based data will ultimately contribute to the improvement of minority health and/or reduction of health disparities in the US.

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, with the following modification:

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

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Use only for applications with due dates on or before January 24, 2018. When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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

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

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the project address research questions of relevance to populations of Caribbean descent in the Caribbean and the US? Will the project provide a foundation for ongoing and/or future population health and comparative research with US and Caribbean populations? Are the proposed collection and analysis of Caribbean-based data likely to contribute to the improvement of minority health and/or reduction of health disparities in the US?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are the roles of US- and Caribbean-based investigators clearly delineated and appropriate? Are there appropriate plans to ensure an equitable partnership and shared decision-making across collaborators? Is there an acceptable communication plan to coordinate between Caribbean and US collaborators?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? Does the Caribbean-based data collection align with relevant and appropriate datasets from the US? Is the plan for analyzing Caribbean-based data well-described and appropriate?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is appropriate technical assistance available from collaborators for investigators from non-research intensive institutions in the Caribbean? Are there adequate capabilities for sharing information and methods for transferring information and data?

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

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not applicable

Not Applicable

Not Applicable

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.

Not Applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

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

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center For Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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.
• Will receive a written critique.

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.
• Representation of countries and populations within the Caribbean.

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.

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 grantee's business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Jennifer Alvidrez, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9567
Email: jennifer.alvidrez@nih.gov

Damali Martin, PhD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-6746
Email: martinda@mail.nih.gov

Helen Hunter Cox, M.H.S.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8163
Email: helen.cox@nih.gov

Georgeanne Patmios, MA
National Institute on Aging (NIA)
Telephone: 301-496-3138
Email: Georgeanne.Patmios@nih.gov

Sung Sug (Sarah) Yoon, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: sungsug.yoon@nih.gov

Delia Olufokunbi Sam, PhD
Center for Scientific Review
Telephone:301-613-6206
Email: olufokunbisamd@mail.nih.gov

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@nih.gov

Carol Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
Email: perryc@mail.nih.gov

Jennifer Cho
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-827-8024
Email: jennifer.cho@nih.gov

Jeff Ball
National Institute on Aging (NIA)
Telephone: 301-402-7732
Email: ballj@nia.nih.gov

Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: osterk@mail.nih.gov

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.