Interventions on Health and Healthcare Disparities on Non-Communicable and Chronic Diseases in Latin America: Improving Health Outcomes Across the Hemisphere (R01 - Clinical Trial Required) is sponsored by National Institutes of Health (NIH), U.S. Department of Health and Human Services. Supports collaborative research to address NCD health disparities among Latin American and U. S.

Hispanic/Latino populations, emphasizing innovative interventions and international partnerships.

PAR-25-342: Interventions on Health and Healthcare Disparities on Non-Communicable and Chronic Diseases in Latin America: Improving Health Outcomes Across the Hemisphere (R01 - Clinical Trial Required) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Minority Health and Health Disparities ( NIMHD ) National Institute of Nursing Research ( NINR ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

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

Office of Research on Women's Health ( ORWH ) Funding Opportunity Title Interventions on Health and Healthcare Disparities on Non-Communicable and Chronic Diseases in Latin America: Improving Health Outcomes Across the Hemisphere (R01 - Clinical Trial Required) R01 Research Project Grant January 28, 2026 - NIH Removing AIDS Application Due Dates from NOFOs. See Notice NOT-OD-26-029 .

March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 .

August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility. Assistance Listing Number(s) Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) is being reissued in accordance with the simplified review criteria in effect for application due dates after January 25, 2025.

The purpose of this Notice of Funding Opportunity (NOFO) is to support innovative and interdisciplinary team research focused on clinical, health services, and/or community-based interventions that address health and healthcare disparities related to non-communicable and chronic diseases (NCDs) with the highest disease burden and mortality in Latin America and among U.S. Hispanics/Latinos.

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

Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

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

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

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Therefore, the overarching goal of this NOFO is to support innovative and collaborative research 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.

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 effective 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 across the region and how they reduce disparities in access, utilization and quality of healthcare and increase 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 mitigating health disparities. 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 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 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 into the future.

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

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

Office of Research in Women's Health (ORWH) Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Required: Only accepting applications that propose clinical trial(s). Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited but need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period.

The maximum project period is 5 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award.

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

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

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

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

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

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

3. Additional Information on Eligibility Applicant organizations may submit more 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. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

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

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

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

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

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- Application Guide must be followed.

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

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. Section III.

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4. Submission Dates and Times Part I.

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

Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration.

NIH and Grants. gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.

gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications .

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide. 5.

Intergovernmental Review (E. O. 12372) This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7. 9.

1 Selected Items of Cost. 7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply Application Guide.

Paper applications will not be accepted. Applicants must complete all required registrations before the application due date. Section III.

Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide . If