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.

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.

Background

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.

Research Objectives

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.

Applicants are encouraged to contact Scientific/Research contacts (listed at the bottom of this NOFO) as far in advance as possible to discuss responsive trial designs, research priorities, and alternative NOFOs. Information about the NIMH mission and priorities can be found in the NIMH Strategic Plan for Research. Applications to this NOFO should largely align with Objectives 3.2 and 3.3 of Goal 3 and Goal 4. Division/branch priorities and key areas of interest are updated on the Division of Translational Research - Geriatrics and Aging Processes Research Branch and Division of Services and Intervention Research webpages.

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 should 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.

Other Considerations

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

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 - 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

• 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)

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

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 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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

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

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

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 (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). 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.

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.

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

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:

Research Strategy

Applicants must include the following sections as part of the Research Strategy. Applicants should not duplicate study details from the PHS Human Subjects and Clinical Trials Information form in the Research Strategy section but may refer to these details to provide context as needed.

Factor 1. Importance of the Research

Significance:

• Justify the potential public health impact of the proposed work in terms of 1) reach and effect on older adults with SMI, and/or 2) meaningfulness of the anticipated outcome(s) compared to existing approaches and/or current state of science in the topic area.
• As appropriate, address the degree to which the proposed intervention, implementation approach, or service delivery strategy is scalable and could be disseminated into practice given typically available resources, typical service and financing structures, and typical service use patterns.
• For pilot studies, detail how the proposed research will generate data that will lead to a firm conclusion about the feasibility of a regular research project grant or full-scale clinical trial and provide information about the anticipated scope and goals of intended future work.
• For full scale studies, discuss how the results of the proposed work will lead to a firm conclusion about the tested hypothesis.
• For projects involving methods development and testing, describe the potential for broad use of results in studies of other target populations and/or outcomes.
• As appropriate, address the degree to which the proposed intervention, implementation approach, or service delivery strategy addresses differences  in access, ongoing engagement, and/or clinical or functional outcomes.

Innovation:

• Highlight how innovative research strategies and design/analytic elements (e.g., adaptive sequential randomization, equipoise stratification, technology-based assessments) are incorporated, as appropriate, to enhance the study's potential for yielding practice-relevant information.
• As relevant, describe how applications of technology or other innovative approaches are leveraged to facilitate the conduct of the research project (e.g., participant identification, data collection) and/or to increase the reach, efficiency, or effectiveness of the intervention or service delivery strategy that is being evaluated.

Factor 2. Rigor and Feasibility

Approach:

• For clinical trials testing person-level interventions or approaches (i.e., the recipients are patients, family members, providers, etc.), detail the plan to explicitly address whether the intervention engages one or more mechanisms of action. Include the following:
  • A conceptual framework that clearly identifies the mechanism(s) of action and the empirical evidence linking the mechanism(s) to the primary outcomes of interest (i.e., clinical symptoms, functional deficits, or patient-, provider- or system-level behaviors/processes that the intervention seeks to improve).
  • Plans for assessing engagement of the mechanism(s) including the specific measures, the assessment schedule, and evidence regarding the validity and feasibility of the proposed measures in the effectiveness context.
  • A statistical analysis plan for examining whether intervention-induced changes in the mechanism(s) are associated with changes in the outcomes. For full scale studies, these analyses might involve formal mediational analyses; for pilot trials, propose plans for a preliminary evaluation of the relation between changes in mechanism(s) and outcomes. The Research Strategy section of the application must include a description of the planned analytic approach for evaluating whether the intervention engages mechanism(s) of action, whereas the full details of the proposed statistical methods should be included in the PHS Human Subjects and Clinical Trials form.
  • In the case of multi-component interventions, specify the conceptual basis, assessment plan, and analytic strategy, as detailed above, for the mechanisms corresponding to each intervention component, as appropriate in the effectiveness context.
• For clinical trials testing system-level interventions or strategies (i.e., the intervention targets structural, organizational, or procedural factors rather than individual service users), describe how the project will explicitly test how, why, for whom, and/or in which settings or under what circumstances the system intervention may be effective. Potential approaches include but are not limited to mediation analyses (e.g., mediator mapping), moderator analysis, temporally organized dismantling designs, and partial/fractional or full factorial designs. This description must include the following elements:
  • A conceptual framework that clearly identifies the variables of interest and the directionality of the effects (e.g., the system or service mechanism(s) and the empirical evidence linking mechanism(s) to system-level behaviors/processes that impact access to quality care).
  • The measures used to assess the variables identified in the conceptual framework.
  • An analytic plan that explicitly assesses how, why, for whom, and/or in which settings or under what circumstances the system intervention may be effective consistent with a test of the system intervention. Provide justification for the sample size based on appropriate study assumptions; plans for interim and final analyses; methods of bias control; and methods for handling missing data (as applicable).
• Describe plans for deployment-focused design and testing that systematically assesses the perspective of community and practice partners (e.g., consumers, providers, administrators, payers) and setting characteristics (e.g., workforce capacity, clinical workflows) to help ensure that the resultant approach is feasible and scalable, robust against implementation drift, and has utility for end-users.
• As appropriate, describe provisions for fidelity monitoring via procedures that are feasible and valid for use in the proposed intervention or implementation setting.
• For studies proposing adaptations of existing interventions, justify the adaptation in terms of (a) theoretical and empirical support for the adaptation target (e.g., a prognostic variable that has been associated with non-response, partial response, patient non-engagement, or relapse); (b) an empirical explanation of how the prognostic variable interferes with the response to the un-adapted intervention; and (c) evidence to suggest that the adapted intervention will result in a substantial improvement in response rate, speed of response, efficiency or other aspects of care, or uptake in community/practice settings.
• For studies that involve the assessment of patient-level outcomes, provide plans for the assessment of suicidal behavior and related outcomes using strategies that can facilitate integration and sharing of data (e.g., see NOT-MH-15-009 for constructs and corresponding assessment strategies), as appropriate, or provide a rationale for excluding such measures if they are not included. In addition, describe provisions for clinical management when suicidal behavior is reported. In situations where it is not appropriate or feasible to include assessment of suicide outcomes due to the nature of the intervention, the target population, or unique issues related to participant burden or safety/monitoring concerns, the application should provide an appropriate justification for excluding these assessments.
• For applications that propose to develop, refine and evaluate new research tools, measures, or methods, describe how the research will lead to validated and deployable products, services, and/or methodologies that are broadly and efficiently usable in community practice settings.
• Applications that propose to integrate and/or analyze existing data sets should discuss how results will enhance and extend our understanding of factors affecting access, continuity, quality, delivery, efficiency, financing, value, fairness and impartiality, or outcomes of care. 

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:

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this Notice of Funding Opportunity (NOFO) are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-23-100). Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this NOFO are expected to use these technologies to submit data to NDA.

To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDA website provides two tools to help investigators develop appropriate strategies: 1) the NDA Data Submission Cost Model which offers a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent available from the NDA's Data Contribution page. Investigators are expected to certify the quality of all data generated by grants funded under this NOFO prior to submission to NDA and review their data for accuracy after submission. Submission of descriptive/raw data is expected semi-annually (every January 15 and July 15); submission of all other data is expected at the time of publication, or prior to the end of the grant, whichever occurs first (see NDA Sharing Regimen for more information); Investigators are expected to share results, positive and negative, specific to the cohorts and outcome measures studied. For more guidance on submitting data to NDA, refer to the NDA Data Sharing Plan on the NDA website. NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary.

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.

Section 2 - Study Population Characteristics

2.5 Recruitment and Retention Plan

Applications must provide a clear description of:

1. Recruitment and Referral sources, including detailed descriptions of the census/rate of new cases and anticipated yield of eligible participants from each source;

2. Procedures that will be used to monitor enrollment and track/retain participants for follow-up assessments;

3. Strategies that will be used to ensure a representative sample;

4. Potential recruitment/enrollment challenges and strategies that can be implemented in the event of enrollment shortfalls (e.g., additional outreach procedures, alternate/back-up referral sources);

5. Evidence to support the feasibility of enrollment, including descriptions of prior experiences and yield from research efforts employing similar referral sources and/or strategies.

2.7 Study Timeline

Applications must provide a timeline for reaching important study benchmarks such as: (1) finalizing the study procedures and training participating clinical site staff; (2) finalizing the intervention manual and assessment protocols, including fidelity measures/procedures, where applicable; (3) enrollment benchmarks; (4) completing all subject assessments and data collection activities, including data quality checks; (5) analyzing and interpreting results; and (6) preparing de-identified data and relevant documentation to facilitate data sharing, as appropriate.

Section 5 - Other Clinical Trial-Related Attachments

5.1 Other Clinical Trial-related Attachments.

For clinical trials applications must include materials related to intervention delivery or training of providers in this section. As appropriate, this may include screenshots of mobile interventions, technological specifications, training manuals or treatment algorithms. Videos are not allowable. Applicants must upload the attachments for Intervention Manual/Materials, as applicable. If more than one set of Intervention Manual/Materials is used, they should be combined in this attachment. Applicants must use the "Intervention Manual/Materials" to name these other attachments files. If there are no intervention manuals/materials, the applicant must provide an attachment with the "Intervention Manual/Materials" file name. Include a statement discussing why intervention materials are not included or relevant to the submission. 

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.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a "Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

NIMH expects investigators for this funding announcement to collect Common Data Elements (CDEs) for mental health human subjects research. Unless NIMH stipulates otherwise during the negotiation of the terms and conditions of a grant award, this Notice applies to all grant applications involving human research participants. The necessary funds for collecting and submitting these CDE data from all research participants to the NIMH Data Archive (NDA) should be included in the requested budget. A cost estimator (https://nda.nih.gov/ndarpublicweb/Documents/NDA_Data_Submission_Costs.xlsx) is available to facilitate the calculation of these costs. NIMH may seek further information regarding CDEs prior to award. Additional information about CDEs can be found at the NIMH webpage on Data Sharing for Applicants and Awardees and NOT-MH-25-055.

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. 

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

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 consider 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 factor 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(s) convened by the Center for Scientific Review, in accordance with NIH peer review policies and practices, 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.

Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO. 

Applications will be assigned 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 National Advisory Mental Health Council. 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.

The NIMH has published policies and guidance for investigators regarding human research protection, data and safety monitoring, Independent Safety Monitors and Data and Safety Monitoring Boards, reportable events, and participant recruitment monitoring (NOT-MH-19-027). The application's PHS Human Subjects and Clinical Trials Information should reflect the manner in which these policies will be implemented for each study record. These plans will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. The NIMH will expect clinical trials to be conducted in accordance with these policies including, but not limited to: timely registration to ClinicalTrials.gov, submission of review determinations from the clinical trial's data and safety monitoring entity (at least annually), timely submission of reportable events as prescribed, and establishment of recruitment milestones and progress reporting.

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.

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.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

Not Applicable

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 

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.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

National Institute of Mental Health (NIMH)
Division of Translation research (DTR)                                           
Email: DTRcommunications@nih.gov

National Institute of Mental Health (NIMH) 
Division of Services and Intervention Research (DSIR)
Email: NIMH.DSIR.inquiries@nih.gov

NOFOReviewContact@csr.nih.gov

National Institute of Mental Health (NIMH) 
Grants Management 
Email: NIMHNOFOGrantsManagement@mail.nih.gov

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.