Advancing Research on Empirically-Supported Interventions for Older Adults Living with Serious Mental Illness (SMI) (R01 Clinical Trial Optional)

The purpose of this notice of funding opportunity (NOFO) is to foster research that will inform and support the optimization, delivery, sustainability, and effectiveness of empirically-supported practices for addressing the mental health needs of older adults with serious mental illness (SMI). To this end, NIMH seeks applications that propose work that is focused on practice-relevant questions and conducted within and/or across settings where older adults with SMI are likely to be identified as needing care (e.g., primary care and geriatric specialty clinics, assisted living and long-term care facilities, and community centers). Applications may propose research related to adapting, optimizing, and implementing efficacious treatment and services interventions and strategies to improve clinical and functional outcomes among aging populations; examining mutable factors that impact fair and impartial mental health care access, utilization, quality, and outcomes and may serve as targets for intervention development for older adults with SMI; and developing and testing innovative treatment and service interventions that address barriers to accessing quality mental health care. Projects may also focus on systems-level factors and approaches for addressing SMI and improving access to evidence-based interventions in later life, such as evaluation of health system policies and practices, interventions that facilitate care transitions and continuity across settings, and strategies to improve care linkages and coordination across systems.

Funding Opportunity Number: RFA-MH-27-180. Assistance Listing: 93.242. Funding Instrument: G. Category: HL. Award Amount: $3M total program funding.

RFA-MH-27-180: Advancing Research on Empirically-Supported Interventions for Older Adults Living with Serious Mental Illness (SMI) (R01 Clinical Trial Optional) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Mental Health ( NIMH ) Funding Opportunity Title Advancing Research on Empirically-Supported Interventions for Older Adults Living with Serious Mental Illness (SMI) (R01 Clinical Trial Optional) R01 Research Project Grant Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON) Companion Funding Opportunity See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose The purpose of this notice of funding opportunity (NOFO) is to foster research that will inform and support the optimization, delivery, sustainability, and effectiveness of empirically-supported practices for addressing the mental health needs of older adults with serious mental illness (SMI).

To this end, NIMH seeks applications that propose work that is focused on practice-relevant questions and conducted within and/or across settings where older adults with SMI are likely to be identified as needing care (e.g., primary care and geriatric specialty clinics, assisted living and long-term care facilities, and community centers).

Applications may propose research related to adapting, optimizing, and implementing efficacious treatment and services interventions and strategies to improve clinical and functional outcomes among aging populations; examining mutable factors that impact fair and impartial mental health care access, utilization, quality, and outcomes and may serve as targets for intervention development for older adults with SMI; and developing and testing innovative treatment and service interventions that address barriers to accessing quality mental health care.

Projects may also focus on systems-level factors and approaches for addressing SMI and improving access to evidence-based interventions in later life, such as evaluation of health system policies and practices, interventions that facilitate care transitions and continuity across settings, and strategies to improve care linkages and coordination across systems.

Funding Opportunity Goal(s) The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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

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

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

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

Check with your institutional officials regarding availability. Use Grants. gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Key Definitions for this NOFO: Older adult: For the purposes of this announcement, "older adult" is defined as individuals with SMI who are 50 years of age and older.

Serious mental illness (SMI): Serious mental illness (SMI) is defined as a mental, behavioral, or emotional disorder resulting in serious functional impairment, which substantially interferes with or limits one or more major life activities.

Disorders include schizophrenia, schizoaffective disorder, bipolar disorder, chronic major depression, obsessive compulsive disorder (OCD), panic disorder, posttraumatic stress disorder (PTSD), and borderline personality disorder. Evidence-Based Intervention: Evidence-based interventions are those that have demonstrated efficacy, safety, and tolerability, and are found to be effective in the general population.

Interventions include drug, devices, psychotherapies, behavioral treatments, and case management services. Empirically-Supported Practices: Empirically-supported practices include both evidence-based and evidence-informed therapeutic interventions, services, and implementation strategies.

Implementation strategies: One or more bundled methods or techniques designed to enhance the adoption and sustainability of a therapeutic or services intervention. Examples include electronic clinical reminders, audit/feedback, training, and practice facilitation.

Implementation strategies seek to improve: (1) acceptability, satisfaction, and perceived fit of extant evidence-based practices; (2) access to and engagement with evidence-based practices; (3) quality and fidelity to evidence-based care; and (4) uptake, scalability, and sustainability.

Hybrid effectiveness-implementation trials (hybrid trials) : Hybrid trials include methods for evaluating intervention effectiveness and implementation factors. In hybrid trials, participants are randomized to conditions at the level of the intervention, the level of the implementation strategy, or at both levels. In intervention settings where randomization is not feasible, a rigorous alternative may be appropriate.

Hybrid type 1 trials emphasize evaluating intervention effectiveness while also assessing consumer-, provider- and setting-level implementation factors. Hybrid type 2 trials place equal emphasis on evaluating intervention effectiveness and the effectiveness of an implementation strategy related to the intervention.

Hybrid type 3 trials emphasize evaluating implementation strategy effectiveness while also gathering patient or consumer outcome data to confirm intervention effectiveness. System intervention : System interventions target system(s) of care, rather than individuals (e.g., individual service users, family members, or providers).

The intervention focus could be across multiple organizational settings or systems (e.g., primary and specialty care, community clinics, assisted living or long-term care facilities) or at multiple levels within a single organization or system (e.g., patient-, provider-, clinic-, and health system-levels).

The independent variable(s), therefore, include the manipulation of structural, organizational, or procedural factors and/or the incorporation of multiple implementation strategies to improve the delivery, effectiveness, and efficiency of mental health services within or across systems. Examples of system interventions include the Collaborative Care Model and Coordinated Specialty Care.

Deployment-focused: Deployment-focused design and testing systematically assess and incorporate the perspectives of community and practice partners (e.g., consumers, providers, administrators, payers) and setting characteristics (e.g., workforce capacity, clinical workflows). This approach helps to ensure that the resultant interventions are feasible and scalable, and that the study results have utility for end-users.

Despite the heightened risk of medical comorbidity, poor functioning, institutionalization, early mortality, and economic costs associated with SMI in late life, older adults with SMI remain under-identified and undertreated due to multiple factors.

While effective preventive, therapeutic, and services interventions exist for younger and middle-aged adults with SMI, few have been adapted to address the unique needs of older adults and tested.

For example, age-related cognitive and physiological changes, co-occurring health conditions, presenting symptom profile and severity, and other individual and interpersonal factors (e.g., perceived stigma associated with mental health and its care, social network and supports, mobility and transportation availability, and financial and residential status) are often not adequately addressed in spite of evidence supporting their association with intervention outcomes and the extent to which older adults seek, receive, and adhere to mental health care.

Structural- and system-level factors also serve as barriers to caring for older adults with SMI, and include: inadequate access to preventive and specialty mental health care services; poor coordination of services required to meet the needs of those with SMI; limited number of geriatricians, mental health and other providers (e.g., primary care providers, occupational therapists, assisted living and nursing home staff, emergency department and hospital staff) with the knowledge and expertise to identify and provide care to older adults with SMI; and unique challenges associated with the transition from general adult health care and housing to geriatric services.

For instance, variations in reimbursement policies and service coverage can complicate and impede care delivery, with many assisted living communities that serve older adults not accepting individuals with SMI and assisted living communities serving adults with disabilities (including mental health) not serving individuals over the age of 65.

Although some progress has been made in establishing an evidence base for interdisciplinary, integrated care models that incorporate empirically-supported practices to address the various factors associated with caring for older adults with SMI, these efforts tend to be specific to late-life depression or anxiety (i.e., Collaborative Care, Program to Encourage Active, Rewarding Lives (PEARLS), Healthy Ideas), with few studies focusing on the refinement and implementation of comprehensive, evidence-based practices for older adults presenting with other types of SMI.

Moreover, implementation of and access to evidence-based interventions for SMI (e.g., Assertive Community Treatment, Cognitive Behavioral Social Skills Training (CBSST), Integrated-Illness Management and Recovery (IIMR), and Helping Older People Experience Success (HOPES)) for older adults in community practice or service settings (e.g., geriatric health, mental health and supportive housing services) remains limited.

Given the rapidly growing older adult population, there is an urgent public health need for therapeutic and services research focused on further adapting, tailoring, and optimizing existing efficacious interventions as well as testing innovative implementation strategies for the delivery, organization, adoption, and sustainability of evidence-based mental health care for older adults with SMI.

This NOFO seeks to support research related, but not limited, to: adapting, optimizing and implementing efficacious treatment and services interventions and implementation strategies to improve mental health outcomes among aging populations; examining mutable factors that impact access, continuity, utilization, quality and outcomes and may serve as targets for future service intervention development for older adults with SMI; and refining and testing innovative treatment and service interventions and implementation strategies that target challenges and systemic barriers to access and quality of mental health care.

Projects may also focus on systems-level factors and approaches for addressing SMI and improving access to evidence-based interventions in later life, such as evaluation of health system policies and practices (including those pertaining to reimbursement and incentive models), workforce development and enhancement (e.g., training in geriatric mental health, task sharing) and incentives to provide services to older adults with SMI, system interventions that facilitate care transitions and continuity across settings, and strategies to improve care linkages and coordination across systems serving older adults with SMI.

Evidence-based and efficacious novel interventions have poor uptake in routine practice, and when deployed, often suffer from "voltage drop," or the documented decrease in the effects of treatment between controlled efficacy trials and implementation into routine practice.

Thus, of particular interest is research on mental health intervention, service, and system models that have the potential to substantially impact practice and public health in terms of the magnitude of likely improvements in key outcomes (e.g., clinical benefit, safety/tolerability profile, value, and efficiency, or scalability potential), as compared to existing approaches.

Studies must evaluate the impact of interventions in the typical consumer when delivered by the typical clinician, lay person, or other provider in routine clinical practice (e.g., geriatric and specialty MH clinics) or in non-mental health settings (e.g. primary care, emergency departments, assisted living, nursing home, and long-term care facilities, private residential settings, community agencies and social services, senior centers, and places of worship) where older adults with SMI are served, interact, and reside.

Moreover, deployment-focused research in response to this NOFO should incorporate the perspectives of community and practice partners and address characteristics of the implementation setting.

Online-only interventions may be appropriate for evaluation when an existing sustainable infrastructure is available to continually connect consumers with the intervention and support ongoing maintenance and delivery outside the research enterprise.

Studies that incorporate technology into the intervention design should align with NOT-MH-18-031 : NIMH High-Priority Areas for Research on Digital Health Technology to Advance Assessment, Detection, Prevention, Treatment, and Delivery of Services for Mental Health Conditions.

Areas of interest include, but are not limited to: Projects that seek to adapt and test established evidence-based practices to improve the mental health outcomes of older adults with SMI.

Projects that test multi-modal or integrated treatment intervention approaches, such as combination treatments or sequenced pharmacological, psychosocial, and/or neuromodulation interventions, to evaluate if combination or sequencing results in synergistic effects on clinical or functional outcomes.

Projects that develop, refine, and test algorithms and strategies for (1) identifying older adults with SMI in various care settings and (2) matching older adults to interventions of appropriate intensity/dose, based on risk status, severity of the presenting mental health problem, as well as the capacity of the older adult or, if applicable, family and other informal support providers, to engage in services.

Projects, for example, may utilize administrative data sources (e.g., electronic health records, claims data) and data science approaches (e.g., predictive analytics, machine learning, etc.) to determine risk and optimize the delivery of appropriate care for SMI.

Projects that test/compare sustainable staff training and supervision approaches (e.g., technology-assisted training, expert telephone consultation, training approaches for alternate or extender staff) that can be used to train providers to initial competence in evidence-based practices, to monitor intervention quality, to address turnover, and to promote sustained fidelity in the delivery of mental health services across a range of clinical modalities, including telehealth, for older adults with SMI.

The cost-effectiveness of various approaches can also be considered.

Projects that involve multidisciplinary teams of providers and test multi-component strategies for optimizing and/or streamlining evidence-based mental health service delivery interventions for older adults with SMI with other cognitive, medical (e.g., cardiometabolic disease), or behavioral health (e.g., substance use) needs and seek to improve adoption, contextual fit, scalability, affordability, and sustainability of integrated care.

Projects that incorporate modular or stepped-care approaches for matching service and treatment components of varying intensity to patients' preferences, presenting symptoms, or areas of greatest need across systems .

For instance, studies may simultaneously or sequentially implement and coordinate targeted case management interventions and evidence-based care across settings serving older adults experiencing social, financial, housing, and food insecurities. Trials may involve family/social network support and psychoeducation, psychiatric rehabilitation, or other social services that are integrated with behavioral health interventions.

Projects testing multi-component system interventions that target different levels and sources of barriers to increase equal access to and quality of mental health services for older adults with SMI.

For example, an intervention may include a combination of measurement-based care, provider incentives, case-mix management strategies, transportation services/mobile units, and combined digital and human interventions to improve the delivery of interventions and mitigate waiting lists. Projects that test novel approaches for complementing or extending the geriatric mental health workforce.

Studies may test, for example, task sharing models that involve clear roles for non-specialty providers and staff (e.g., direct care workers such as nursing assistants and home health aides), community health workers, peers, or lay persons and incorporate scalable and sustainable approaches for training and supervision, safety monitoring, credentialing, and reimbursement.

Projects that examine financing and payment structures and strategies, including alternative payment models, that incentivize the implementation and sustainment of evidence-based practices for SMI in late life and examine their effects on clinical, functional, and health services (e.g., access, continuity, and equivalent care) outcomes.

Evaluation and comparison of models that facilitate cross-sector coordination between mental health, primary care, long-term care, other healthcare, and social service providers is encouraged. Studies may also examine strategies for combining funding from multiple sources, including braiding, blending, sequencing, or other financing strategies.

Scale and Scope of Research This NOFO uses the R01 research project grant mechanism to support full-scale research projects and pilot studies.

The application should clearly specify the goals of the project and justify the methods (e.g., sample size, analytical strategy) and the requested resources (funds, investigator effort, project period) as appropriate to the proposed stage of science (i.e., pilot-stage project or full-scale project).

Pilot-stage projects s hould be designed to examine the feasibility of the research approach (e.g., feasibility of recruiting and retaining participants), should provide an opportunity to refine and pilot test the experimental protocols (e.g., assessment protocols and the experimental intervention protocol, as relevant), and should yield pilot data necessary for informing subsequent, well-powered studies.

Full-scale projects should be supported by pilot data and should be statistically powered to provide a definitive answer, such that the findings have the potential to inform practice. Study designs may also address hypotheses regarding predictors and moderators of outcomes. This NOFO also invites both clinical trials and projects that do not involve clinical trials.

Depending on the research question, a variety of data sources (e.g. electronic health records or claims data, prospectively collected participant-level data) and methodologically rigorous approaches may be indicated. These may include randomized controlled trials (RCTs), quasi-experimental designs with non-randomized comparison groups, time-series designs, and other designs of equivalent rigor and relevance.

Projects seeking to develop new components or unbundle or test the unique contributions of existing components (and/or combinations of components) of multi-component service delivery interventions may use designs such as the following: factorial designs and their derivatives (e.g., fractional factorial); Multiphase Optimization STrategy (MOST); Sequential, Multiple Assignment, Randomized Trials (SMART); randomized encouragement; and interrupted time series designs or other quasi-experimental approaches.

Proposed measures of key constructs and variables (e.g., mechanisms or mediators, moderators, and primary outcomes) should be validated, generally accepted by the field, and considered in context of NIMH's expectations for the use of common data elements (see NOT-MH-20-067 ).

Given the emphasis on practice-relevant questions, outcomes of interest extend beyond symptom reduction to include short- and long-term assessment of patient-centered outcomes, including changes in functioning across domains (e.g., global, interpersonal/social, and family functioning) and other key outcomes of interest/importance to key stakeholders (e.g., staffing, efficiency, safety, value, access, engagement, or other factors related to the eventual implementation, scaling, and sustainment of new treatment and/or services approaches).

NIMH encourages the use of measures that are as direct and objective as is feasible in the intended intervention setting and/or span more than one level of assessment when appropriate.

Finally, to expedite the translations into practice, this NOFO is intended to support research that reflects a deployment-focused model of system design and testing that meaningfully considers the perspective of key end users and beneficiaries of the research (e.g., service users, health system decision makers, professional practice and community organizations, third-party payers, public mental health policy makers, front line clinicians, representatives from the population of interest) and the characteristics of the settings (e.g., resources, including workforce capacity; existing clinical workflows) where optimized mental health interventions and services are intended to be implemented.

Collaborations between academic researchers and clinical or community practice partners or networks are expected. Preliminary data should reflect an existing partnership between academia and the system or service setting.

Studies should capitalize on existing infrastructure to maximize efficiencies, facilitate procedures and enhance the sustainability of the approach, and increase the relevancy of the intervention and implementation strategies tested.

Potential partners include practice-based research networks such as the NIMH-sponsored ALACRITY Research Centers or Suicide Research Centers, SAMHSA's Certified Community Behavioral Health Clinics , NIH's CARE for Health ; institutions with Clinical and Translational Science Awards; and public and private health care systems' electronic medical records, administrative databases, and patient registries.

Guidance on Clinical Trials Applicants interested in proposing clinical trials or alternative funding mechanisms covering other stages in the NIMH clinical research pipeline are encouraged to review the information on Support for Clinical Trials at NIMH and the NIMH webpage on clinical research .

Consistent with the NIMH experimental therapeutics approach, for studies proposing trials testing intervention effectiveness and implementation strategies at the individual patient (e.g., patient recipient of psychotherapy or a brief engagement intervention to improve help-seeking and mental health treatment literacy) or provider (e.g., provider recipient of an in-person or app-based training on evidence-based psychotherapy) level , at least one hypothesized mechanism of action (confirmation of target engagement) is required.

Moreover, clinical trials of intervention effectiveness and implementation strategies at the individual/personal level must include a hybrid effectiveness-implementation trial design that proposes to simultaneously evaluate the clinical impact of the intervention on symptoms, functional outcomes, or risk factors associated with a mental disorder and implementation factors or strategies that impact intervention access, engagement, quality, or sustainability.

For studies focused on testing the effectiveness of service/system-level interventions, applicants should provide a conceptual model that justifies the empirical relationship between the system interventions and strategies and outcomes. They must also propose analyses that assess how the interventions and strategies are associated with and account for changes in outcomes.

In both person-level and system-level intervention types, methodology should go beyond assessing only whether an intervention is effective, but also what factors the intervention is addressing to mitigate issues like outcome, access, and quality barriers that contribute to the person-level intervention voltage drop that is observed when interventions are deployed in healthcare, community, and other settings.

Moreover, please note that this NOFO supports intervention development work when there is a compelling empirical justification for the proposed augmentation, optimization, personalization, or sequencing approach.

This justification may be based on evidence that the unmodified intervention or strategy is associated with suboptimal clinical response, engagement, or adherence, is a poor fit for specific populations, or is likely to encounter implementation challenges in routine care, community, or online settings (see recommendation 2. 4.

1, page 19 regarding the empirical justification for intervention adaptations in the NAMHC Workgroup Report , From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illnesses). Applications Not Responsive to this NOFO include: The following types of studies are not responsive to this NOFO.

Applications proposing such studies will be considered non-responsive and will not be reviewed or considered for funding. Applications that are not focused on interventions and/or services for older adults (i.e., ages 50 and above) with SMI.

Psychopathology-focused studies whose purpose is to examine risk, protective, and etiological factors, rather than focusing on informing and/or testing interventions and services for older adults with SMI.

Studies that involve developing novel interventions that are grounded in emerging findings from basic science, rather than involving empirically-supported interventions and targets that are appropriate for testing and delivery in practice settings.

Applications that propose to evaluate and test interventions and service delivery in research settings rather than routine care, community, or online settings and/or propose the use of research therapists or include other features specific to research or academic contexts (i.e., studies that incorporate features or involve resources that are not representative of typical practice settings or substantially impact generalizability).

Studies focused on attitudes towards mental health and mental health care without also examining mental health service access, engagement, quality and/or outcomes of care. For studies that involve testing person-level preventive or therapeutic interventions or implementation strategies : Applications that do not propose a hybrid effectiveness-implementation trial design.

For studies that involve testing person-level preventive or therapeutic interventions or implementation strategies: Applications that do not propose an evaluation of the mechanism(s) of action and its impact on the primary outcomes, including the following components:(1) specified mechanism(s) of action; (2) measurement plans designed to assess the mechanism(s) of action and clinical outcomes in the intervention setting; and (3) analytic plan for evaluating whether intervention-induced mechanism(s) of action are associated with outcomes.

For studies that involve testing system-level interventions: Applications that do not: (1) explicitly test how, why, for whom, and/or in which settings or under what circumstances the system intervention may be effective (e.g., using moderator, mediator analysis, temporally organized dismantling designs); and (2) include an explicit analytic plan and specify the variables to be measured.

Multi-site trials: This NOFO may be used for support for multi-site trials that require participation of two or more collaborative research sites for completion of the study (e.g., in order to increase sample size or accelerate recruitment), with subcontracts to support enrollment and data collection at additional research sites and multiple PI/PD arrangements for research site PIs who contribute complementary research expertise, as appropriate.

Suicide-Related Outcomes: Effective treatment of mental illness has the potential to reduce morbidity and mortality associated with suicide attempts and deaths. Lack of attention to the assessment of these outcomes has limited our understanding of the degree to which effective mental health interventions might offer prophylaxis.

Accordingly, NIMH encourages research that includes assessment of suicidal behavior in clinical trials using strategies that facilitate data sharing and harmonization (see NOT-MH-23-100 and NOT-MH-15-009 ). Data and Safety Monitoring: The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring ( NOT-MH-19-027 ).

The application's PHS Human Subjects and Clinical Trials Information, including the Data and Safety Monitoring Plan, should reflect the policies and guidance in this notice. Applications with data collection plans that involve multiple respondent groups should include human subject protections, consenting procedures, and planned enrollment tables for each participant group.

Plans for the protection of research participants and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NIMH intends to commit $3,000,000 in FY 2027 to fund up to 5 or 6 awards. Application budgets are not limited but need to reflect the actual needs of the proposed project.

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

Section III.

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

Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) Foreign Organizations/ International Collaborations NIH will no longer issue awards (new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025. Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors. Foreign Organizations/International Collaborations 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. NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16. 8 Collaborative International Research Awards .

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

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. Foreign organizations must obtain a NATO Commercial and Government Entity (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