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 SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The National Institutes of Health (NIH) participating Institutes and Centers (ICs), in collaboration with the Global Alliance for Chronic Diseases (GACD), invite applications for implementation research focused on addressing risk factors for common noncommunicable diseases (NCDs) in World Bank-defined low- and middle-income countries (LMICs) and American Indian/Alaska Native (AI/AN) populations in the United States (US). Air, water, and soil pollution; lack of greenspace; urban heat islands; lack of safe infrastructure for walking, cycling, and active living; lack of access to healthcare facilities, lack of health insurance, and cost of medications; housing condition; and wide availability of tobacco, alcohol, and unhealthy foods and beverages contribute to the NCD epidemic in city environments. In the context of this Funding Opportunity Announcement (FOA), "cities" include urban centers, informal settlements, slums, and periurban areas. This FOA supports applications that propose implementation research to reduce the risks of NCDs in the context of cities in LMICs and/or among AI/AN populations in US cities, with the potential to equip policymakers and practitioners with evidence-based strategies for prevention and/or management of NCDs among disadvantaged populations globally. NIH defines implementation research as the scientific study of the use of strategies to adopt and integrate evidence-based health interventions into clinical and community settings to improve individual outcomes and benefit population health.

This FOA uses the bi-phasic, milestone driven R61/R33 grant mechanism. Awards made under this FOA will initially support a one-year milestone-driven initiation (R61) phase, with possible transition to an implementation (R33) phase of up to four additional years. Only projects that meet the scientific milestones and award requirements of the R61 phase may transition to the R33 phase. Applications submitted in response to this FOA must address both the R61 and R33 phases.

Applications will be accepted from US and LMIC institutions only. Eligible LMIC institutions are defined by the World Bank at the following link: datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups

Introduction

NCDs account for 60% of deaths globally where 8 in 10 deaths caused by NCDs occur in LMICs. While NCDs account for the greatest loss of disability-adjusted life years (DALYs) around the world, research to study prevention and treatment is relatively under-resourced in LMICs and AI/AN communities where the burden is increasing. The GACD was formed in 2010 in response to this concern and supports research and associated training to accelerate and improve prevention and treatment of NCDs in under-resourced environments.

The GACD represents 15 of the world’s largest funding agencies, including the NIH, and is the first alliance to specifically address NCDs. Collectively, GACD partner agencies provide over 80% of global public funding for health research and, since 2010, have supported 110 projects in the areas of hypertension, lung diseases, diabetes, mental health, cancer, stroke, and hypertension/diabetes intervention scale-up. GACD has supported 1,200 researchers at 300 institutions in 70 countries through investment of over US $220 million through its partner agencies. NIH has supported 11 GACD awards across these NCD domains.

This FOA is aligned with the overall GACD initiative to support implementation research, defined as the scientific study of the use of strategies to adopt and integrate evidence-based health interventions into clinical and community settings to improve individual outcomes and benefit population health. Implementation research examines which strategies work, for whom, and under what circumstances to promote the uptake, scale-up and spread of effective interventions. Projects may also address how interventions can be adapted and scaled up in ways that are feasible, acceptable, accessible, sustainable, and equitable in a given national context.

Implementation research is especially relevant in LMICs, where it can help ensure that limited resources are invested in cost-effective interventions.

Implementation research is needed to account for the complexities of the systems in which interventions are implemented since other approaches often fail to address these. Results of implementation research support evidence-based policymaking that can build robust programs to improve public health. Additional information and resources on implementation research can be found on the GACD website.

Specific Challenge

Chronic NCDs, such as diabetes, cardiovascular disease, neurological disorders and stroke, respiratory diseases, certain cancers, and mental health disorders are the leading cause of morbidity and mortality in both LMICs and high-income countries (HICs), especially within AI/AN Tribal Nations. The COVID-19 pandemic has brought NCDs further into the spotlight, as the majority of those who have experienced severe illness and death have had one or more underlying NCDs. Reducing the burden of NCDs is therefore critical to building more resilient, equitable, and healthier societies.

More than half of the world’s population currently live in cities and this number is projected to rise to 68% by 2050. Recent climate related disasters, such as major flooding events, fires, and droughts, highlight how cities are at the forefront of the climate change crisis. There is an urgent need to equip local authorities and policymakers with strategies for maximizing the health-promoting potential of cities, while minimizing or reversing environmental degradation and health inequities.

Fortunately, cities provide tremendous social, cultural, and economic opportunity, and have the potential to become engines of good health and support climate change adaptation. Innovative health-focused programs, policies, and infrastructure, such as public smoking bans, bikeable streets, greenspace, and vehicle emission laws, can shape the behaviors of millions of people and decrease exposure to environmental contaminants. City leaders are beginning to demonstrate a commitment to climate action, for example, through their participation in the C40 Cities network. Applicants to this FOA are invited to conduct implementation research that leads to improved understanding of how specific interventions can be better adapted to different city environments and/or scaled within and across cities, taking into account unique local social, political, economic, and cultural contexts.

A number of behavioral change interventions, as well as those that increase the health-promoting potential of environments and decrease risks associated with unhealthy environments, are effective in reducing, delaying, or preventing the risk of NCD onset or disease progression. However, research is lacking in how to integrate such interventions into communities and health systems, and/or how to target these interventions within the context of the built environment and cities, especially in LMICs and within AI/AN populations within US cities. Applicants responding to this FOA are invited to meet this challenge.

Research Objectives and Scope

Summary

The aim of this FOA is to invite applications for implementation research focused on addressing common NCD risk factors associated with city environments and related health inequities among populations in LMICs and AI/AN populations in the US.

Responsive applications will:

• select one or more city/ies in which the research will be conducted and justify why a particular context is considered a city;
• select one or more evidence-based interventions known to reduce NCD risk factor(s) associated with city environments, justify the choice of intervention(s), and provide evidence of the intervention’s effectiveness, acceptability, feasibility, and potential for long-term health and other impacts;
• adapt intervention(s) for selected study population(s) based in one or more city/ies, taking into account the unique social, political, economic, and cultural context(s) while also justifying why these adaptations will not compromise the known effectiveness of the selected intervention(s);
• provide a research plan for investigating how to promote the uptake and/or scale-up of the intervention(s) in the selected study population(s), using validated implementation research frameworks;
• specifically address issues of equitable implementation to ensure interventions reach the populations that need them the most;
  • address health equity, defined by the WHO as the absence of unfair, avoidable or remediable differences among groups of people, whether those groups are defined socially, economically, demographically, or geographically or by other dimensions of inequality (e.g. sex, gender, ethnicity, disability, or sexual orientation);
  • address social determinants of NCDs in the relevant populations and assess culturally-tailored intervention strategies, including, for instance, studies that integrate tribal ecological knowledge (TEK) in AI/AN communities;
• have an appropriate strategy for measuring implementation research outcomes and potentially real-world effectiveness outcomes and indicators (related to NCD prevention and, if feasible, planetary health and/or non-health sectors), including stakeholder-relevant outcomes (e.g., functioning, health services use, and others);
• demonstrate a commitment to stakeholder and community engagement;
• provide opportunities for implementation research capacity building within project teams;
• demonstrate a commitment to reducing the research team’s ecological footprint with the proposed intervention, implementation strategies and research practices; and
• demonstrate equitable partnerships and shared leadership between high-income country (HIC)/LMIC and/or non-Tribal Nation/Tribal Nation members of the project team, and between the project team and external stakeholders, including written letters of support from these groups and associated Institutional Review Boards (IRBs), as appropriate.

In addition, applicants are encouraged (though not required) to:

• explore themes of planetary health and/or climate and health in the context of their projects, investigating how to best implement intervention(s) known to positively impact both human and ecological health and/or improve human resilience to the health impacts of climate change in city environments;
• conduct implementation research on multisectoral interventions that cut across health, environmental, social, employment, housing, and/or other sectors;
• explore the generalizability of implementation strategies by conducting studies in two or more cities, with adequate descriptions of city characteristics (e.g., built environment vs. informal settlements, population, sociodemographic diversity, etc.);
• focus on at-risk populations, such as individuals or communities living in informal settlements, urban post-disaster settings, or in situations of homelessness; and
• explore how to best implement digital technology interventions. (In July 2021, the GACD held a workshop focusing on best practices for planning and delivering sustainable and equitable digital health interventions for NCDs in LMICs and Indigenous communities. A summary report, which may assist with proposal planning, is available here).

NIH, through its partnership with GACD, is committed to supporting research undertaken through genuine multi-sectoral partnerships among diverse academics, policymakers, local authorities, for-profit institutions, non-profit organizations, and community groups from HICs, LMICs, and/or AI/AN Tribal Nations. Where possible, research questions should be driven by local stakeholders and other intended beneficiaries of the research project.

Study population and life course approach

The NIH, in partnership with the GACD, aims to improve health equity with selected study populations residing in LMIC cities and/or AI/AN populations residing in cities in the United States. The context of cities as the study site and focus may include informal settlements near urban centers, peri-urban environments, and city centers. Applicants must justify why their study area of focus is considered a city.

In all cases, the study population may include both people with existing NCDs, those without existing NCDs, or a combination of both, but the focus must be on addressing common NCD risk factors, such as depression, diabetes or impaired glucose tolerance, high cholesterol, high blood pressure, obesity, unhealthy diet, smoking, physical inactivity, and excess alcohol consumption. Applicants may propose implementation research focused on interventions that are implemented at the individual, family, community (e.g., work or school), population, and/or structural level within the context of cities. Applicants may also propose implementation research focused on NCD prevention/management in people living with stable, chronic HIV/AIDS or other infectious disease comorbidities.

Evidence-based interventions

The research to be undertaken will focus on the implementation of one or more evidence-based interventions in preventing or reducing exposure to one or more common NCD risk factors in the context of cities.

Proposals might focus, for example, on the WHO Best Buys and/or other evidence-based strategies and interventions (in the context of cities) that address: tobacco and nicotine avoidance; hypertension management, including reducing salt intake; limiting alcohol consumption, promoting regular physical activity, a healthy diet, and body weight; healthy sleeping patterns; clean air; and/or social and psychological well-being. Such strategies and interventions might focus on behavioral change and/or improving equitable access to resources necessary for health promotion.

Addressing health equity

Poverty, racism, ethnic discrimination, stigma, historical trauma, and other inequities are directly associated with detrimental health outcomes. All projects should consider the social determinants of health and discuss their potential impact on the effective implementation of the intervention(s). If there is a focus on a particular population (e.g. gender, race/ethnicity, Tribal Nation) then the reason for this should be justified.

In order to promote health equity, studies can aim to address differences in intervention access, uptake, and effectiveness in socially disadvantaged groups and develop strategies for reducing inequities. To facilitate this process at the data analysis stage, studies can be designed to address such differences (e.g., capturing sex/gender differences, intersectional impacts on health outcomes). Guidance for conducting sex/gender-responsive and intersectional research is available on the GACD call webpage.

Outcome measures

Inclusion of contextually appropriate implementation research outcomes (e.g., uptake, acceptance, feasibility, cost, etc.) is a key for driving appropriate assessment and potential scaling beyond the proposed research.

Where appropriate, outcomes (e.g., health or financial outcomes, uptake metrics, patient satisfaction, and others) should be measured in those targeted directly as well as others who are intended to benefit from the intervention (for example, the infants of mothers who received the intervention while pregnant, or the adult parents or grandparents of children who received the intervention).

Stakeholder and community engagement

For research evidence to have a strong likelihood of being taken up into policy or practice and informing the scale up of effective interventions, it is vital that project teams engage the appropriate stakeholders, including decision makers such as policymakers, ministry officials, tribal leaders, IRBs, and non-governmental organization leaders, who can help sustain the project’s implementation, facilitate scale up, and use the knowledge generated from the project after the grant ends. Engaging community partners and community-based organizations as key stakeholders is highly encouraged. Stakeholders also include end users and the direct beneficiaries of research, such as youth groups, diverse community members, patients, and their caregivers. All stakeholders should be engaged at all stages of the research project, from initial ideation of research questions, throughout the duration of the project, and afterwards during the knowledge translation and dissemination of findingsphase. More information about stakeholder and communityengagement, including links to resources for planning such engagement, can be found on the GACD webpage.

Implementation research capacity building

Implementation research is a relatively young discipline and the NIH and GACD are dedicated to increasing research capacity and capability in this field among researchers, health professionals, and public health leaders through skill building, knowledge sharing, and networking. As such, a key element of this program is to provide opportunities within each funded project to build implementation research capacity especially, but not exclusively, in lower resourced environments, such as LMICs or AI/AN communities, and amongst early career researchers from these communities.

Equitable partnership and governance

Equity considerations also extend to the governance of project teams in order to ensure fair and equal collaboration, especially between HIC/LMIC and/or non-Tribal Nation/Tribal Nation members (both collaborations within the research teams and with community partners). NIH-aligned resources for planning equitable research partnerships are available on the GACD call webpage. As such, the GACD and NIH encourage equitable governance arrangements within research teams, with input from stakeholders and community representatives to drive contextually-informed, equitable research and data ownership.

Compliance with international standards and best practices

It is expected that all research conducted under and funded by this initiative will comply with relevant internationally accepted standards and best practices. These include:

• Standards for Reporting Implementation Studies (StaRI) Statement;
• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice (ICH-GCP) and relevant NIH guidelines;
• standards relevant to specific study designs including SPIRIT and CONSORT for clinical trials, and STROBE for observational studies;
• ethics and other governance requirements as applicable in the countries where the research will be conducted;
• registration of all clinical trials before recruitment of the first trial participant in clinicaltrials.gov; and
• reasonable measures to ensure that sponsors, researchers, and institutions publish or otherwise disseminate the analysis of data and interpretation of research results (i.e., the findings) in a findable, accessible/interpretable, andtimely manner without undue restriction.

Expected impacts of this initiative

The projects funded in response to this FOA will collectively:

• contribute to the UN Sustainable Development Goal 3.4 to reduce premature mortality from NCDs by one third by 2030;
• reduce health inequities linked to socioeconomic status, sex/gender, race/ethnicity, age, and other social and structural factors within the context of cities;
• provide cities globally with evidence-based strategies and tools for promoting population health in equitable and environmentally sustainable ways, enabling cities to better address the challenges of rapid urbanization, growing social inequalities, and climate change;
• advance local, regional, or national preventative health policies addressing common risk factors for NCDs;
• provide evidence and recommendations to national programs and policies;
• inform health service providers, policy, and/or other decision makers on the effective adaptation and/or scaling up of interventions at in the context of cities;
• improve local capacity for implementation research, data harmonization, and stakeholder engagement for management and prevention of common NCD risk factors; and
• improve capacity for implementation research.

Structure

This FOA utilizes a bi-phasic, milestone-driven grant (R61/R33) mechanism consisting of a study start-up and developmental (R61) phase with possible transition to an implementation (R33) phase. Awards made under this FOA will support a maximum project period of 5 years, consisting of a 1-year R61 phase and 4-year R33 phase. Only R61 projects that meet the scientific performance milestones and award requirements of the R33 phase may transition to the R33 phase. Applications submitted in response to this FOA must address both the R61 and R33 phases and are strongly encouraged to use project management principles as appropriate.

Phases of Award

The R61 phase will support planning activities focused on sustainable uptake of proven-effective interventions throughout the community of interest. This phase should include activities such as the identification of the population in which the strategies to deliver and scale up proven-effective interventions will be tested, establishment of collaborative relationships, further honing and contextualization of the strategies to be tested during the R33 implementation phase, conduct of a health needs assessment (if applicable), and preparation of all details required for conducting a clinical trial, such as finalization of the protocol and the informed consent/assent document; the development of the manual of operations and procedures, case report forms and other resources necessary to the performance of the protocol; Data and Safety Monitoring Board (DSMB) review of the protocol; and Institutional Review Board approval of the trial.

The R33 phase will support implementation of the proposed clinical trial beyond the necessary planning and study start-up activities of the R61 phase.

Milestones and Transition to the R33 Phase

Delineation of phase transition milestones is a key characteristic of this FOA. The application is expected to propose a well-defined set of milestones for the R61 phase as well as the R33 phase. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be performance-based to enhance the likelihood that the project will be completed on-time and on-budget. It is understood that the proposed milestones for the R61 phase may be revised as activities in the R61 phase progress. In the event of an award, the PD/PI and NIH staff will negotiate the final list of milestones for each year of support. Near the completion of the R61 phase, the applicant will be required to submit a detailed transition request for the R33 phase.

Criteria used to determine which R61 projects will be continued into the R33 phase include the following:

• Successful completion of transition milestones (original or modified with prior approval) for the R61 period of the project;
• Potential of the plan for successful conduct of the R33 phase, including established partnerships;
• Successful completion of all study protocol materials and approval by relevant governance bodies (including, but not limited to, Data and Safety Monitoring Board (DSMB), Institutional Review Board (IRB), and NIH programmatic/grants management approvals);
• Original R61/R33 peer review recommendations;
• Availability of funds;
• NIH IC program priorities.

The quality of the planning, design, and documentation products for the R61 phase will be given key consideration when the NIH considers the transition to the R33 implementation phase. If at any time the project fails to make progress toward meeting milestones (e.g., developing a final protocol and/or manual of procedures including a detailed description of study procedures and process details; completing training of study staff, etc.), the NIH may consider ending support and negotiating an orderly close-out of the award.

For grants funded through this program, awardees may submit an R33 transition package no less than three months before the completion of the R61 phase. This R33 transition package should include an R61 progress report describing in detail the progress towards the R61 milestones, all information typically included in the annual Research Performance Progress Report (RPPR), and a description of how research proposed for the R33 phase will be supported by the completion of the R61 phase milestones. These materials will be evaluated by NIH Program staff, per the above criteria. It is anticipated that not all R61 awardees will be transitioned into the R33 phase. Applicants must be aware that use of a no-cost extension at the end of the R61 period could impact the award of the R33.

NIH IC-Specific Priorities

Participating NIH Institutes, Centers, and Offices (ICs) provided specific statements of interest for this FOA below. Applicants can obtain more information on research interests for each of the NIH participants in this FOA at their websites and through their Scientific/Research contact listed in this announcement. The proposed research must be relevant to the interests of at least one of the participating NIH ICs (other than FIC). Applicants should consult with the IC contact listed in this FOA to verify interest.

Fogarty International Center (FIC)

The Fogarty International Center Strategic plan (http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx) states the following relevant goals: 1) Buildresearch capacity through individuals, institutions, and networks to meet future and evolving global health challenges; 2) Stimulate innovation in the development and implementation of technologies and other locally relevant solutions to address global health problems; 3) Support research and research training in implementation science; 4) Advance research on prevention and control of the dual burden of communicable and non-communicable diseases and disabilities; and 5) Build and strengthen partnerships to advance global health research and research capacity.

National Heart, Lung, and Blood Institute (NHLBI)

The National Heart, Lung, and Blood Institute encourages innovative implementation research that is within scope of NHLBI’s Strategic Vision, and aligns with in-country national heart, lung, blood, and sleep (HLBS)-related non-communicable disease programs and policies for national population impact.

NHLBI is interested in supporting interventions in urban environments to reduce NCD risk: implementation research focused on individual, community, and/or structural level interventions that can reduce NCD risk and/or maximize the health-promoting potential of cities. Trans-disciplinary and multi sectoral partnerships among the health, urban planning, and behavioral sciences are encouraged. Applications are encouraged that:

• leverage one or more evidence-based interventions known to reduce NCD risk factor(s) linked to urbanization. Applications should clearly explain the choice of intervention(s) and provide evidence of the intervention’s effectiveness, feasibility, acceptability, environmental sustainability (particularly for projects focusing on the built environment), and potential for long-term health and other impacts;
• address adaptability and fidelity of the intervention(s) for a selected study population(s) based in one or more city/ies, taking into account the unique social, political, economic, and cultural context(s);
• provide a research plan for investigating innovative implementation strategies [e.g. how to promote the uptake, scale-up and spread of these intervention(s) in the selected study population(s)] using validated implementation research frameworks;
• address issues of equitable implementation to ensure interventions reach the populations that need them the most;
• have an appropriate strategy for measuring implementation research and effectiveness outcomes;
• demonstrate a commitment to stakeholder engagement;
• provide opportunities for implementation research capacity building within project teams;
• demonstrate equitable partnerships and shared leadership between HIC-LMIC members of the project team, and between the project team and external stakeholders;
• demonstrate a commitment to environmental sustainability;
• conduct implementation research on how best to increase the uptake of multisectoral interventions that cut across health, environmental, social, employment, housing, and/or other sectors; and
• explore how to best implement interventions harnessing digital technology adaptations (e.g., Artificial Intelligence, Big Data, telemedicine).

The R61/R33 Clinical Trial Required mechanism allows for novel, biphasic, and milestone-driven implementation research clinical trials for HLBS disease prevention and control at regional and/or national levels within LMICs and AI/AN populations. The initiation phase of the trial would be up to one year (R61), and a full enrollment and clinical trial execution phase would be up to four years (R33). For interest in mechanistic and non-clinical trials research, please refer to the companion funding opportunity: PAR-23-042: Implementation Research on Noncommunicable Disease Risk Factors among Low- and Middle-Income Country and Tribal Populations Living in City Environments (R01 Clinical Trial Optional).

National Institute of Mental Health (NIMH)

The National Institute of Mental Health encourages studies across the research spectrum, from basic through translational science to intervention development and efficacy, effectiveness, and implementation research. Mental disorders may be defined according to existing diagnostic criteria or along dimensions of neurobehavioral functioning according to the NIMH Research Domain Criteria (RDoC) framework. If existing diagnostic criteria are to be used, investigators should include plans for addressing heterogeneity within the diagnostic category or categories.

All applications that propose clinical trials to develop or test preventive, therapeutic, or services interventions, including studies that test dissemination and implementation strategies, are encouraged to follow the NIMH’s experimental therapeutics approach to intervention development and testing (see NIMH Clinical Trials FOAs). It is recommended that investigators contact NIMH Scientific/Research staff well in advance of submitting applications to discuss the match to NIMH priorities.

NIH Office of Disease Prevention (ODP)

The NIH Office of Disease Prevention is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention. In partnership with the 27 NIH Institutes and Centers, the ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. The ODP co-funds research that has strong implications for disease and injury prevention and health equity and that includes innovative and appropriate research design, measurement, and analysis methods. The ODP has a specific interest in projects that develop and/or test preventive interventions. For this FOA, the ODP is interested in clinical trials that advance implementation science and reduce the risks of NCDs in the context of cities in LMICs and/or among AI/AN Tribal Nation populations in cities in the United States, with the potential to equip policymakers and practitioners with evidence-based strategies for the prevention of NCDs.

The ODP provides co-funding for, but does not award grants. Applications must be relevant to the objectives of an NIH Institute or Center. Please reach out to the relevant NIH contact listed for questions regarding research priorities and funding. ODP only accepts co-funding requests from NIH Institutes and Centers. For additional information about ODP, please refer to the ODP Strategic Plan for Fiscal Years 2019 2023.

Applications Not Responsive to the FOA

Applications proposing the following types of projects will NOT be considered responsive and will be withdrawn by the Program Official of the funding institute prior to review:

• Applications that do not propose an NIH-defined clinical trial and provide assessable phased award transition milestones;
• Applications which are not focused on evidence-based interventions known to reduce NCD risk factor(s) associated with city environments, do not justify the choice of intervention(s), and do not provide evidence of the intervention's effectiveness, acceptability, feasibility, and potential for long-term health and other impacts;
• Applications that do not focus on implementation research or hybrid effectiveness-implementation studies (i.e., ones that do not have the primary aim of informing the selection of an intervention or evaluating the effectiveness of an already proven intervention to be implemented in a given city context). All proposals must contain a plan to implement and/or scale up an intervention already proven to directly impact human health or address the social determinants of health;
• Applications that do not specifically address issues of equitable implementation to ensure interventions reach the populations that need them the most;
• Applications that do not propose implementation research capacity building for LMIC and/or AI/AN Tribal Nation researchers;
• Applications that do not demonstrate equitable partnerships and shared leadership between high-income country (HIC)/LMIC and/or non-Tribal Nation/Tribal Nation members of the project team, and between the project team and external stakeholders, including written letters of support from these groups;
• Applications that do not demonstrate a commitment to stakeholder and community engagement;
• Applications that do not adapt intervention(s) for selected study population(s) based in one or more city/ies, and justify why a particular context is considered a city/ies, taking into account the unique social, political, economic, and cultural context(s) while also justifying why these adaptations will not compromise the known effectiveness of the selected intervention(s);
• Applications proposing research studies in LMICs but do not include an LMIC institution and associated key personnel as a part of the research team;
• Applications that do not utilize quantitative and qualitative methods and mixed methods designs;
• Applications that do not provide a research plan for investigating how to promote the uptake and/or scale-up of the intervention(s) in the selected study population(s), using validated implementation research frameworks;
• Clinical trials, validation studies or intervention studies of the efficacy of a new pharmacological agent or behavioral intervention; and
• Applications focusing on interventions using pharmacological agents and/or biomedical devices which do not show evidence of their effectiveness (including affordability) in low-resource contexts.

Applications that do not explicitly address the terms of this PAR will be considered non-responsive and will not be reviewed.

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 FOA.

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

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

Other

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

Non-domestic applicant organizations are restricted to organizations in LMICs, which are defined by The World Bank as low-, lower-middle-, or upper-middle-income economies - http://data.worldbank.org/about/country-classifications/country-and-lending-groups.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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.

• 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 his/her 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 FOA 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 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 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 FOA. 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 SF424 (R&R) Application Guide 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.

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:

Brad Newsome, Ph.D.
Telephone: 301-480-8389
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 FOA.

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.

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.

Applicants should include all institutions where research will occur as performance sites, including relevant U.S. and foreign institutions.

SF424(R&R) Other Project Information

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

The application must contain the following information, according to the instructions below. The information provided here will be considered by reviewers and is meant to supplement, not duplicate, information provided in the Research Plan. The following documents must be uploaded as separate pdf files with the names indicated below.

1. Milestone Plan. The filename "Milestone Plan" should be used to name this attachment. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. The Milestone Plan must describe objective, measurable annual milestones for each year of proposed research, divided between the activities of the 1-year R61 phase and the 4-year R33 phase, as outlined in Section I. Funding Opportunity Description. The milestone plan should address anticipated challenges to meeting milestones and propose potential mitigation or corrective action strategies.

Milestones may be refined and finalized in consultation with NIH Program Staff prior to award, if granted. Milestones may include, but are not limited to:

• Milestones that may be completed during the R61 phase include, but are not limited to:
  • Identification of the population in which the strategies to deliver and scale up proven-effective interventions will be tested
  • Demonstration that the necessary study population is available for appropriate testing of implementation research strategy
  • Establishment of collaborative relationships with key stakeholders including community partners
  • Establishment of skills development programs for practitioners
  • Identification of the strategies to be tested during the R33 implementation phase;
  • Collection of data to determine feasibility of study procedures and establish a timeline for accrual of study participants
  • Finalization of the health needs assessment
  • Finalization of the statistical analysis plan
  • Finalization of the study protocol
  • Acceptance of the protocol by NIH
  • Preparation of all documents required for conducting the proposed implementation research and/or clinical trial, if proposed, including:
    • Development of case report forms and other resources necessary to the performance of the trial
    • Preparation of informed consent(s), manual of operations, study procedure documents for practitioners, study-specific data management plan, etc.
    • Comprehensive clinical trial project management plan that includes a description of all relevant activities associated with trial launch, conduct, and completion, and on-time and on-budget performance metrics
    • All necessary regulatory approvals, as well as provision of the necessary drugs, devices or other resources
    • Finalization and Institutional Review Board/Data and Safety Monitoring Board approval of the trial protocol and related study documents
  • Study participant enrollment plan
• Milestones that may be completed during the R33 phase include, but are not limited to:
  • Study activation
  • Enrollment of the first patient participant
  • Enrollment and randomization, if applicable, of 25%, 50%, 75% and 100% of the projected study population
  • Achievement of retention target for the study population
  • Dissemination of research results
  • Completion of data collection time period
  • Completion of primary outcome data analyses
  • Reporting of results in clinicaltrials.gov

SF424(R&R) Senior/Key Person Profile

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

Provide evidence that the PD(s)/PI(s) and key personnel have:

• The necessary implementation research expertise for the proposed project;
• The expertise and capacity to form a multidisciplinary team that can facilitate collective efforts to determine best ideas or approaches;
• The capacity to foster and coordinate successful collaborations and manage complex projects, which will contribute to the coordinated completion of the aims, and therefore, the scientific objectives of the program.

Document the relevant experience of each PD/PI and all key personnel and clearly define their roles and responsibilities in their program. Applications proposing Multiple PD(s)/PI(s) are required to include at least one PD/PI who has a primary academic appointment in an LMIC or AI/AN Tribal Nation institution where the project will occur.

R&R Budget

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

The GACD will organize and lead the broader network, arranging cross-project working groups and annual joint meetings that all awardees are expected to attend. Accordingly, applicants must budget for annual costs of having two team members participate in one annual three-day face-to-face meeting of the GACD network for implementation research (international meeting location to vary annually). Attendance at this meeting is required for the PI and another key person from each awardee team, with participants from the LMIC or AI/AN Tribal Nation encouraged to attend. Teams are also encouraged to include a junior investigator team member in each annual meeting. For planning purposes, applicants should also budget to attend a start-up meeting in the Washington, DC area during year 1 of the grant in addition to the GACD Annual Meeting (international location to vary annually).

If applicable, budgets should include all costs associated with Data Safety and Monitoring Board (DSMB) and Institutional Review Board (IRB) activities, including preparing reports for the DSMB and IRB, meeting reimbursement for DSMB members, support for at least two DSMB meetings per year, and Clinical Study and Site monitoring. Applicants should assess the need for liability insurance for DSMB members and provide a plan commensurate with the risk of the trial. The budget should include provision for executing the plan proposed. Include a plan for assessing DSMB member conflict of interest and include associated costs in the budget.

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:

Applications must address the following to be considered responsive to this FOA:

• Describe the one or more city/ies in which the research will be conducted and justify why a particular context is considered a city, its relevance in the associated LMIC or AI/AN Tribal Nation setting or context, and how the proposed study is evidence-based and known to for addressing NCD prevention or mitigation across the lifespan.
• Clearly explain the one or more evidence-based interventions known to reduce NCD risk factor(s) associated with city environments, justify the choice of intervention(s), and provide evidence of the intervention’s effectiveness, acceptability, feasibility, and potential for long-term health and other impacts.
• Provide a concise description of the aims of the implementation research study to be conducted. Specific implementation strategies should be clearly delineated, explaining how the study addresses a particular aspect of delivering, scaling up, or sustaining one or more evidence-based interventions in LMICs or among AI/AN groups at the population level. Provide evidence that the proposed research is responsive to local needs, sociocultural and economic contexts, interests, and capacities.
• Clearly describe the expected implementation outcomes: acceptability, uptake and adoption, affordability, appropriateness and feasibility, costs, fidelity, penetrance, sustainability, etc. and any plans for dealing with missing data.
• Propose the use of indicators and measures of project context, reach, outcomes, and scale-up potential. The study should also include assessment of implementation costs and propose an economic evaluation and budgetary impact analysis as an integral part of the proposed research.
• Describe how the study is designed to inform understanding of key mediators/mechanisms of action of the implementation, scale up, or sustainment effort. Note that applicants proposing to conduct a clinical trial under this FOA must adhere to NIH’s requirements for clinical trials.
• Describe plans to consider multi-level contextual factors (e.g., socioecological factors).
• Describe how the project leverages existing programs and platforms (e.g. research, data, delivery platforms), if relevant.
• Describe how the study is designed to take into consideration relevant gender and cultural aspects, social determinants of NCDs, and issues related to at-risk populations.
• Provide a description of how the project is designed to promote a culture of evidence-informed learning and effective uptake of results by embedding real-time monitoring/evaluation throughout the intervention selection and scale up process.
• Discuss the potential challenges in preparing and implementing the research protocol and how these will be addressed.
• Incorporate considerations for capacity building for implementation research and knowledge translation, particularly within the countries and across the regions where the research will be conducted.
• Describe how suitable management and government structures will be established to ensure relevant stakeholders are appropriately engaged throughout the research. Applications should outline equitable governance arrangements in place for your projects.
• Describe how the proposed research will fully consider ethical issues (e.g., related to research with populations in at-risk circumstances; potential harmful or inequitable impacts of research outcomes; and appropriate mechanisms for protection of sensitive data while enabling data sharing for research purposes).
• Ensure conflicts of interest are appropriately minimized or managed to protect the scientific integrity and credibility of the research and fulfill ethical obligations to research participants, particularly in situations where interventions are supported by the private sector and/or there is the potential for commercial gains.
• Indicate plans for implementation research capacity building within the project, especially, but not exclusively, for early career researchers and for team members from lower resourced environments, such as LMICs or AI/AN Tribal Nation communities.

Investigators

Describe (while minimizing repetition from the individual biosketches) how the expertise and experience of the investigator team will be leveraged, organized, and managed to meet the objectives of the proposed project. Address the management and coordination of efforts. Identify the collaborative process for engagement and involvement of stakeholders to participate fully in all phases of the implementation strategy, including design, deployment, testing, and reporting of results.

Letters of Support

To be considered complete, applications must include letter(s) of support from collaborating partners, and/or other organization(s) indicating their relevant expertise and commitment to participate. Applications without the required letter(s) of support will not be reviewed.

If partial funding is to be provided by sources other than NIH, provide letter(s) of support from the source(s) signed by an authorized representative.

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.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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 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.

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 FOA 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.

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.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

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.

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 convened by the Center for Scientific Review (CSR), 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 will receive a written critique.

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

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

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

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 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 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.

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: Generaland 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:

• Federalwide Research Terms and Conditions
• 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 must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. 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.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/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 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 FOAs 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]

Brad Newsome, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-480-8389
Email: [email protected]

Andrea Horvath Marques, M.D., MPH, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-646-7320
Email: [email protected]

Elizabeth L. Neilson, PhD, MPH, MSN
Office of Disease Prevention (ODP)
Phone: 301-827-5578
Email: [email protected]

Makeda J Williams
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-435-4582
E-mail: [email protected]

Center for Scientific Review (CSR)

Email: [email protected]

Bruce Butrum
Fogarty International Center (FIC)
Telephone: 301-496-1670
Email: [email protected]

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-811
Email: [email protected]

Anthony Agresti
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-827-8014
E-mail: [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.