Part 1. Overview Information

Key Dates

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

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

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

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

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.

Introduction

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.

Specific Challenge

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:

• Select one or more evidence-based interventions (or complex intervention) known to promote integrated multimorbidity management. Applicants should 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. While it is recognized that the evidence for how to manage NCD multimorbidity is still emerging, particularly in LMICs, a period of testing the effectiveness of an intervention that your team has developed/adapted for local implementation is still appropriate.
• Explore the implementation of these intervention(s) for a selected study population(s) based in one or more LMICs and/or within AI/AN populations in the US, taking into account the unique social, political, economic, and cultural context(s) in which the study will take place. Applicants should justify why any adaptation will not compromise the known effectiveness of the selected intervention(s);
• Provide a research plan using validated implementation research frameworks or hybrid design research;
• Have an appropriate strategy for measuring implementation research outcomes and real-world multimorbidity effectiveness outcomes and indicators;
• 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;
• Engage an appropriately expert and skilled research team which can ensure a suitable multidisciplinary approach and that demonstrates equitable partnership and shared leadership between HIC and LMIC researchers, and/or non-Tribal Nation and AI/AN members of the project team and external collaborators/partners through a clear governance strategy, including written letters of support from these groups and associated Institutional Review Boards (IRBs), as appropriate;
• Provide a collaborator/partner engagement strategy with evidence of support/engagement from key partners for delivering patient-centered care and a pathway to sustain the proposed intervention after the project funding period ends;
• Provide opportunities for implementation research capacity building for early-career researchers and team members from lower-resourced environments, such as LMICs or AI/AN communities.

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

• Use mixed methods to answer research questions;
• Adopt a life course approach, adapting the intervention to one or more key life stage(s) critical for reducing the onset or progression of multimorbidity;
• 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 application planning, is available here];
• Explain how the team will minimize their environmental footprint when conducting this research project.

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):

• Strategies for improving multimorbidity identification, stratification/staging, management, and/or monitoring such as investigating strategies for adapting and implementing the protocol(s) described in the WHO Package of Essential NCD Interventions (WHO PEN) that address multimorbidity management. Projects may focus on integrating NCD care into clinics that typically focus on the management of infectious diseases, such as HIV or tuberculosis clinics, or the integration of NCD care into maternal and child health clinics;
• Strategies to streamline and improve quality of care among individuals with multimorbidity to reduce fragmentation of services, including task-sharing and/or the use of clinical decision-making tools;
• Strategies that optimize appropriate medication and (non-pharmacological) therapeutic prescribing, adherence, and/or reduced drug interactions/ adverse effects;
• Interventions that improve transitions through the health system, from community to primary to tertiary care and beyond, such as to home care or hospice;
• Health behavioral change interventions that target different risk factor clusters (e.g., exercise, nutrition, tobacco, alcohol and substance abuse).

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 intervention’s 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 intervention’s 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 project’s 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:

• 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, and timely manner without undue restriction.

Expected Impacts of this Initiative

The projects funded in response to this NOFO will collectively:

• Contribute to the United Nations Sustainable Development Goal 3.4 to reduce premature mortality from NCDs by one third by 2030;
• Decrease the fragmentation of care for patients living with multiple chronic conditions, and ensure continuity of care across all stages of disease progression;
• Expand the availability of effective, equitable, efficient, integrated, patient-centered, safe, and timely care for patients living with NCD multimorbidity;
• Reduce health inequities; and
• Improve local capacity for implementation research, data collection and harmonization, and collaborator/community engagement for NCD multimorbidity management.

Structure

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:

• 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

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 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 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:

• leverage one or more evidence-based interventions known to reduce NCD multimorbidity risk factor(s) linked to fragmented models of care for HLBS diseases. Applications should clearly explain the choice of intervention(s) and provide evidence of the intervention’s effectiveness, feasibility, acceptability, environmental sustainability, and potential for long-term health and other impacts;
• address adaptability and fidelity of the intervention(s) for a selected study population(s) based on HLBS multimorbidities, 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 partner and community 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 partners;
• conduct implementation research on how best to increase the uptake of multisectoral interventions for HLBS multimorbidities 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-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 NIMH’s 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 Women’s Health (ORWH)

The Office of Research on Women’s Health (ORWH), part of the NIH Office of the Director, collaborates with 27 NIH Institutes and Centers to promote rigorous research focused on women’s 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 women’s 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 Not Responsive to the NOFO

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 which are not focused on evidence-based interventions known to reduce NCD risk factors(s) multimorbidity, 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 context). All applications 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 researchers;
• Applications that do not demonstrate equitable partnerships and shared leadership between HIC-LMIC and/or non-Tribal Nation-AI/AN members of the project team, and between the project team and external collaborators, including written letters of support from these groups;
• Applications that do not demonstrate a commitment to collaborator and community engagement;
• 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.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

• 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 Organizations)

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.

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

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

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

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

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

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Brad Newsome, Ph.D.
Telephone: 301-480-8389
Email: [email protected]

Page Limitations

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.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply- Application Guide must be followed.

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 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

• Collection of any data to determine feasibility of study procedures and establish a timeline for accrual of study participants
• Finalization of a health needs assessment
• Finalization of a study protocol
• Acceptance of the protocol by NIH
• Finalization of study-related documents, including consent/assent documents, that are ready for submission to IRB and/or applicable oversight committees (such as a Data and Safety Monitoring Board)
• Finalization of the statistical analysis plan
• Near-final drafts of all documents necessary to implement the study (e.g., Manual of Procedures, study procedure documents for practitioners, study-specific data management plan)
• Practitioner skills development
• Study activation
• Enrollment of the first patient participant
• Enrollment and randomization, if applicable, of 25%, 50%, 75% and 100% of the projected study population
• Retention target for the study population
• Completion of data collection time period
• Completion of primary outcome data analyses
• Reporting of results in ClinicalTrials.gov, if applicable

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- 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 milestones, 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 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.

R&R Subaward Budget

All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply- Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

Applications must address the following:

• Describe the evidence-based intervention(s) being employed within the research study known to promote integrated multimorbidity management, its relevance in the associated LMIC or AI/AN population setting or context, and provide evidence of the intervention's effectiveness, acceptability, feasibility, and potential for long-term health and other impacts.

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 intervention’s real-world effectiveness will be supported by a well-conducted systematic review.

• Provide a concise description of the aims of the implementation research study to be conducted. Explain how the study addresses a particular aspect of delivering, scaling up, or sustaining one or more evidence-based interventions in LMICs or within AI/AN populations.
• Provide evidence that the proposed research is responsive to local needs, sociocultural and economic contexts, interests, and capacities.
• 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 NOFO must adhere to NIH’s requirements for clinical trials.
• Describe how the project leverages existing programs and platforms (e.g. research, data, delivery platforms), if relevant.
• 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.
• Incorporate considerations for capacity building for implementation science 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.
• Describe how the proposed research will fully consider ethical issues (e.g., related to research with populations in vulnerable 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 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

• Identify the implementation strategies that will be tested and discuss how the proposed implementation strategy represents an improvement over currently used strategies and/or standards of care.
• Describe the conceptual framework of the proposed validated implementation strategy.
• Specify how the proposed implementation strategy will be adaptable and responsive to the context and account for cultural and organizational factors.
• Identify key implementation facilitators and barriers that could affect the adoption, adaptation, integration, scale up and future sustainability of the implementation strategy.
• Describe plans to consider contextually-relevant implementation elements such as workflow impact, process adjustments, mitigation strategies, and implementation research measures that are applicable in diverse global settings
• Describe plans to consider multi-level contextual factors (e.g., socioecological factors)
• 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.
• Describe plans to document and evaluate the quality, fidelity, and delivery of the implementation strategy
• Discuss the potential challenges in preparing and implementing the research protocol and how these will be addressed

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:

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

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

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.

PHS Assignment Request Form

All instructions in the How to Apply- Application Guide must be followed.

Foreign Organizations

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.

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

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

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

Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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 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 organization’s 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 [email protected].

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.

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. 

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.

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 submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

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 applicant’s 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 applicant’s 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.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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 recipient’s 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).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

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.

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 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.

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]

Makeda J Williams, PHD
NHLBI - NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Phone: 301-435-4582
E-mail: [email protected]

Vidya Vedham, Ph.D.  
National Institute of Mental Health (NIMH)
Email: [email protected] 

Regine A. Douthard, MD, MPH

Office of Research on Women’s Health (ORWH)

Tel: 301-451-2729

Email: [email protected]

Center for Scientific Review (CSR)

Email: [email protected]

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

Laurel Kennedy, M.A.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301 827 4777
Email: [email protected]

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

Section VIII. Other Information

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

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