National Institutes of Health (NIH)
Fogarty International Center (FIC)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Mental Health (NIMH)
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)
The National Institutes of Health (NIH) participating Institutes, Centers, and Offices (ICOs), in collaboration with the Global Alliance for Chronic Diseases (GACD), invite applications for implementation research that aims to improve the availability of effective, equitable, efficient, integrated, patient-centered, safe, and timely care for people living with multiple long-term conditions (non-communicable disease (NCD) multimorbidity) in low- and middle-income countries (LMICs) and/or within American Indian/Alaska Native (AI/AN) populations in the United States. This Notice of Funding Opportunity (NOFO) supports innovative approaches to identifying, understanding, developing, and implementing strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, tools, policies, and guidelines. In addition, studies to advance dissemination and implementation research methods and measures into application are encouraged.
This NOFO uses the bi-phasic, milestone driven R61/R33 grant mechanism. Awards made under this NOFO 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 NOFO must address both the R61 and R33 phases.
All applications must be within the scope of the mission of one of the Institutes/Centers listed above (see "Components of Participating Organizations," excluding the Fogarty International Center which manages this program but does not support awards). Applications will be accepted from US and World Bank-defined LMIC institutions only.
30 days before application due date
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
February 07, 2025 | February 07, 2025 | May 07, 2025 * | July 2025 | August 2025 | October 2025 |
November 05, 2025 | November 05, 2026 | January 07, 2026 * | March 2026 | May 2026 | July 2026 |
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.
Not Applicable
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.
IMPORTANT: Per NOT-OD-24-086 updated application forms (FORMS-I) will be used for this opportunity. The updated forms are not yet available and will be posted 30 calendar days or more prior to the first application due date. Once posted, you will be able to access the forms using one of the following submission options:
The National Institutes of Health (NIH) participating Institutes, Centers, and Offices (ICOs), in collaboration with the Global Alliance for Chronic Diseases (GACD), invite applications for implementation research that aims to improve the availability of effective, equitable, efficient, integrated, patient-centered, safe, and timely care for people living with multiple long-term conditions (non-communicable disease (NCD) multimorbidity) in low- and middle-income countries (LMICs) and/or within American Indian/Alaska Native (AI/AN) populations in the United States. This Notice of Funding Opportunity (NOFO) supports innovative approaches to identifying, understanding, developing, and implementing strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, tools, policies, and guidelines. In addition, studies to advance dissemination and implementation research methods and measures into application are encouraged.
This NOFO uses the bi-phasic, milestone driven R61/R33 grant mechanism. Awards made under this NOFO 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 NOFO 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. While it is not required (although encouraged) for applications submitted to this NOFO by LMIC institutions to have US partners, all applications submitted to this NOFO by US institutions are required to involve LMIC researchers as key personnel.
NCDs account for 60% of deaths globally. Importantly, this global burden is felt even more deeply in low- and middle-income countries (LMICs), and low-resource settings of high-income countries (HICs), such as within tribal nations—even though NCD risk factor burden is often lower in LMICs, due to the ongoing epidemiological transition from communicable to non-communicable disease risk factors as the primary drivers of health burden, mortality rate is much higher due in part to the lack of access to quality, integrated health services and the poor availability of early interventions and effective NCD prevention programs. While NCDs account for the greatest loss of disability-adjusted life years (DALYs) around the world, they are relatively ignored and under-resourced, especially in LMICs where the burden is rising at the fastest rates throughout the world. In response to this major concern, the Global Alliance for Chronic Diseases (GACD) (www.gacd.org) was formed in 2010 as a partnership of 15 Associate Member health research funding agencies around the world to coordinate funding for research and research training on NCDs in LMICs and among tribal nation communities of HICs. GACD supports research and intervention scaling to address the burden of NCDs practically, effectively, contextually, and sustainably. Specifically, GACD supports implementation research that examines what works, for whom and under what circumstances, and how interventions can be adapted and scaled up in ways that are accessible and equitable. Projects funded through the GACD program are encouraged to work toward both location-specific and globally transferable lessons across low- and high- income countries.
Since 2011, the GACD has awarded over $375 million in implementation science research grants focused on preventing and managing NCDs in low-resource contexts. GACD has now supported over 1,300 researchers at over 250 institutions in 80+ countries through investment in 182 funded research projects to-date. GACD Associate Members issue aligned funding announcements each year to address global health issues associated with chronic, non-communicable diseases; as such, funding announcement focus areas have included both targeted opportunities for specific NCDs and cross-cutting opportunities (please see https://www.gacd.org/funding for more information). Together, the GACD Associate Members aim to foster collaboration and coordination of research programs by agreeing on joint research priorities and funding world-class research.
This NOFO 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.
NCD multimorbidity refers to the co-occurrence of multiple long-term (chronic) conditions, at least one of which is an NCD. Chronic NCDs include cardiovascular disease, respiratory diseases, certain cancers, musculoskeletal disorders, diabetes, hypertension, hematological disorders, sleep disorders, and mental illness. The high prevalence of NCD multimorbidity is projected to rise with the aging world population and the increasing burden of NCDs. NCD multimorbidity has a profound impact on patients, and is associated with premature death, physical disability, substance abuse, poor quality of life, depression, and financial difficulties from high costs of care. It is also associated with difficulties in adherence to and high rates of adverse effects from treatment with multiple medications. In addition, due to poor health and the complexity of managing their conditions, patients with multimorbidity are high utilizers of health care, straining already over-burdened health care systems, especially in low-resourced contexts.
Addressing multimorbidity demands a shift from fragmented models of care, that treat individual health issues separately as they occur, to a more holistic integrated care model that provides a whole person focus on health management. The World Health Organization advocates that health systems move towards offering a continuum of quality NCD preventative, diagnostic, curative, rehabilitative, and palliative care services, that are available and accessible to all, independent of economic circumstances.
Evidence for how to manage NCD multimorbidity is emerging, mostly from research in HICs. This evidence suggests that primary healthcare, integrated and coordinated care, patient-centered interventions, digital health technology, and optimized medication therapy are key to improved management of NCD multimorbidity. However, implementing patient-centered strategies for treating NCD multimorbidity remains challenging and largely unexplored in disadvantaged contexts, especially in LMICs. Adapting and scaling such models is critical to improving quality of life; reducing disability; reducing the burden of care taking on (typically female) family members and reducing health system costs. Applicants responding to this NOFO are invited to meet this challenge.
Research Objectives and Scope
Summary
The aim of this NOFO is to invite applications for implementation research that will generate evidence about when, for whom, and under what circumstances, patient-centered approaches can improve integrated care for patients with NCD multimorbidity in LMICs and/or within AI/AN populations in the US.
Responsive applications will:
In addition, applicants are encouraged (though not required) to:
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 partners and other intended beneficiaries of the research project.
Study population and life course approach
The NIH, in partnership with GACD, aims to address health equity in LMICs and within AI/AN populations in the US. The study population may include patients with existing NCD multimorbidity (e.g., studies focusing on rolling out screening services for multiple NCDs). The study population may also include patients with chronic infectious disease(s) (e.g., studies that focus on integrating NCD management into an HIV or tuberculosis clinic) or a mixture of both.
Evidence-based interventions
Study teams should develop an implementation research plan to assess patient-centered, evidence-based interventions focused on patient management or self-management, or interventions that transform communities, clinical practice, and/or health systems.
The following are potential interventions or strategies that applicants may consider in their implementation plan (please note that this is not an exhaustive list):
It is expected that projects will focus on management of patients with existing multimorbidity and will not focus on prevention of multimorbidity (though projects focusing on the secondary prevention of increased severity of existing NCDs through risk factor management are appropriate). Projects that focus on screening initiatives should focus specifically on screening for multimorbidity and also investigate strategies for the timely management or referral of identified cases.
Applicants should describe the evidence that demonstrates the intervention is effective and justify why the intervention is likely to also be effective in the selected study population(s). Ideally, evidence of the interventions real-world effectiveness will be supported by a well-conducted systematic review where available. However, the GACD recognizes that the evidence for how to manage NCD multimorbidity is still emerging, particularly in LMICs. Using an implementation hybrid design in testing the effectiveness of an intervention that your team has adapted for local implementation is therefore usually appropriate.
The NIH and GACD do not limit applicants to any particular design for testing effectiveness of the intervention; however, a validated implementation research framework should underpin the study.
For more information regarding selection of implementation research frameworks, please see the Fogarty International Center Toolkit: Overcoming Barriers to Implementation in Global Health.
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
The proposed primary outcome measures should be implementation research outcomes to assess multimorbidity. With regard to multimorbidity, applicants are encouraged to explore any combination of chronic diseases, which can include multimorbidity of NCDs and chronic infectious diseases. The specific combination of diseases should be justified using local or regional epidemiological data about their co-occurrence. Outcome measures should appropriately address implementation tackling multimorbidity, and not focus on one condition.
Applications may also contain a strategy for measuring other secondary outcomes (or proxy outcomes) that demonstrate the interventions real-world effectiveness in the local context and target populations. To improve data standardization, wherever feasible, applicants are encouraged to use measures developed by the GACD for monitoring patient-centered multimorbidity outcomes in LMICs. Other health or non-health outcome measures, especially those identified as important by patient participants and/or critical for advancing health equity, are also welcome.
Collaborator and community engagement
For implementation research 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 interested, affected, or relevant parties and collaborators. These include decision makers such as policymakers, ministry officials, non-governmental organization leaders and community leaders. It is important to include collaborators/partners who can help sustain the projects implementation, facilitate scale up, and use the knowledge generated from the project after the award ends.
Collaborators/partners also include patients, their family members, and caregivers. Their contributions should be nurtured through meaningful engagement from the outset, not only as participants in the research undertaken. Patient engagement throughout the research project is critical to developing patient-centered models of care.
Applicants should show evidence of appropriate collaborator/partner engagement and include letters of support from proposed partners where possible. All partners should be engaged at every stage of the research project, from initial ideation of research questions, throughout the duration of the project, and afterward during the knowledge translation phase. Applicants should also provide a clear plan for continuing to engage with partners. More information about collaborator and community engagement, including links to resources for planning such engagement, can be found on the GACD resources 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 among 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 and AI/AN 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 partners 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:
The projects funded in response to this NOFO will collectively:
This NOFO 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 NOFO 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 NOFO 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 NOFO. 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:
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.
Potential applicants are strongly encouraged to contact NIH IC program staff (listed below) early in the application process to discuss the alignment of their technical proposal with the goals of this NOFO, the NIH IC, and the GACD program. NIH ICO-specific priorities include the following:
Fogarty International Center (FIC)
NOTE: While the Fogarty International Center manages this program on behalf of NIH, FIC does not accept applications for this funding opportunity. Applications may only be submitted to partner ICs for funding consideration.
National Heart, Lung, and Blood Institute (NHLBI)
The National Heart, Lung, and Blood Institute encourages innovative implementation research that is within scope of NHLBIs 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 i ntegrated management of HLBS multimorbidities: implementation research focused on integrating interventions in clinical, community, and public health settings for optimizing management and care for patients coping with multiple conditions. NHLBI is interested in interventions that demonstrate a commitment to patient-centered approaches that can improve integrated care for HLBS multimorbidity care. Multi-disciplinary and multi-sectoral partnerships among academics, policymakers, local authorities, for-profit institutions, non-profit organizations, and community groups from HICs, LMICs, and/or AI/AN Tribal Nations. are encouraged. Applications are encouraged that:
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-25-213 Implementation Research for Multi-morbidity Management in the Context of Non-communicable Diseases in Low- and Middle-Income Countries and US Tribal Populations (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 NIMHs experimental therapeutics approach to intervention development and testing (see NIMH Clinical Trials NOFOs). It is recommended that investigators contact NIMH Scientific/Research staff well in advance of submitting applications to discuss the match to NIMH priorities.
Office of Research on Womens Health (ORWH)
The Office of Research on Womens Health (ORWH), part of the NIH Office of the Director, collaborates with 27 NIH Institutes and Centers to promote rigorous research focused on womens health issues. ORWH is currently inviting applications to supplement active NIH awards from any of the listed Institutes and Centers listed in the announcement. The goal is to conduct research on non-communicable diseases (NCDs) and multimorbidity chronic NCDs that impact womens health across the lifespan. This includes conditions such as cardiovascular diseases, respiratory illnesses, cancers affecting women, musculoskeletal disorders, diabetes, hypertension, hematological disorders, sleep disorders, and mental health issues. Research proposals are especially encouraged from Low- and Middle-Income countries (LMICs) and among American Indian/Alaska Native (AI/AN) populations in the United States.
ORWH emphasizes the importance of interdisciplinary approaches to effectively address research questions. Applications seeking ORWH co-funding in response to this NOFO, should ensure that the proposed work is aligned with at least one goal and objective outlined in the NIH-Wide Strategic Plan for Research on the Health of Women 2024-2028
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:
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.
Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
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).
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. See Section IV.7 below if requesting $500,000 or more in direct costs in any year (excluding consortium F&A).
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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic applicant organizations are restricted to LMIC organizations/institutions, in which LMICs 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 Organizations) 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 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.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the 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.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
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.
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.
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:
The letter of intent should be sent to:
Brad Newsome, Ph.D.
Telephone: 301-480-8389
Email: brad.newsome@nih.gov
All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.
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.
All instructions in the How to Apply- Application Guide must be followed.
Applicants should include all institutions where research will occur as performance sites, including relevant U.S. and foreign institutions.
All instructions in the How to Apply- 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. 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:
Include plans for recruitment of the proposed study population with clear demonstration that the necessary study population is available for appropriate testing of implementation research strategy
All instructions in the How to Apply- Application Guide must be followed.
Provide evidence that the PD(s)/PI(s) and key personnel have:
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.
All instructions in the How to Apply- 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. Teams are also encouraged to include a junior 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.
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, with the following additional instructions:
Applications must address the following:
Clearly explain the intervention and its components. Applicants must also describe the evidence that demonstrates the intervention is efficacious and articulate the expected outcomes. Ideally evidence of the interventions real-world effectiveness will be supported by a well-conducted systematic review.
Indicate plans for 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 communities.
Implementation Strategies
Investigators
Without repeating information from the individual biosketches, describe 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.
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.
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.
Other Plan(s):
All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply- Application Guide.
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
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, NIHs 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.
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.
Applications must be submitted electronically following the instructions described in the How to Apply Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organizations profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
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.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Applicants are required to follow the instructions for post-submission materials, as described in the policy
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.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.
Reviewers will evaluate Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate criterion score.
Significance
Innovation
Specific to this NOFO:
Approach
Rigor:
Feasibility:
Specific to this NOFO:
Investigator(s)
Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.
Environment
Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.
Specific to this NOFO:
As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects; 2) adequacy of protection against risks; 3) potential benefits to the subjects and others; 4) importance of the knowledge to be gained; and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, evaluate: 1) the justification for the exemption; 2) human subjects involvement and characteristics; and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.
As applicable, evaluate the full application as now presented.
As applicable, evaluate the progress made in the last funding period.
As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.
Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group 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 submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicants federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicants integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipients business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
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).
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.
Not Applicable
Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
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: GrantsInfo@nih.gov (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: support@grants.gov
Brad Newsome, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-480-8389
Email: brad.newsome@nih.gov
Makeda J Williams, PHD
NHLBI - NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Phone: 301-435-4582
E-mail: willimak@mail.nih.gov
Vidya Vedham, Ph.D.
National Institute of Mental Health (NIMH)
Email: vidya.vedham@nih.gov
Regine A. Douthard, MD, MPH
Office of Research on Womens Health (ORWH)
Tel: 301-451-2729
Email: douthardr@mail.nih.gov
Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov
Bruce Butrum
Fogarty International Center (FIC)
Telephone: 301-496-1670
Email: butrumb@mail.nih.gov
Laurel Kennedy, M.A.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301 827 4777
Email: laurel.kennedy@nih.gov
Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-811
Email: tkees@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.