Part 1. Overview Information

Key Dates

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

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

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

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

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

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

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



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Key Definitions for this NOFO:

Youth: For the purposes of this announcement, youth are defined to include children, adolescents, and youth transitioning to adulthood (i.e., birth to 25 years old).

Evidence-Based Intervention: Evidence-based preventive and therapeutic 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 as well as evidence-informed preventive and therapeutic interventions, services, and implementation strategies.

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, schools, juvenile justice) 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(s) the manipulation of structural, organizational, procedural, and interpersonal factors and/or incorporate 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.

Implementation strategy: Methods or techniques designed to enhance adoption of a therapeutic, preventive, or services intervention. Examples include electronic clinical reminders, audit/feedback, training, and practice facilitation. Under this NOFO, testing implementation strategies is appropriate for approaches that target systems of care and/or multiple levels within a system or setting, as well as implementation strategies that target provider behavior (e.g., a provider training or support activity like academic detailing). 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): A trial design that takes a dual focus in assessing clinical effectiveness and implementation. Hybrid designs typically take 1 of 3 approaches: (a) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation (Type 1); (b) dual testing of clinical effectiveness and implementation interventions/strategies (Type 2); (c) testing of an implementation strategy while observing and gathering information on the clinical intervention’s impact on relevant clinical, functional, or population level outcomes (Type 3).

Deployment-focused: Deployment-focused design and testing systematically assesses and incorporates 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.

Task shifting versus task sharing: Youth receive mental health services from a range of potential providers in a variety of settings (e.g., specialty mental health clinics, primary care, emergency departments, schools, justice system settings). The application should justify the focus of the proposed intervention/services in terms of the alignment with the provider qualifications and setting capacity (e.g., settings outside healthcare systems or lacking clinical support might focus on identification, referral, and engagement with healthcare services or prevention). Task-shifting approaches that involve using research resources or other unsustainable resources to train and supervise non-clinicians in the delivery of therapeutic interventions will be considered low priority. Task-sharing models that propose and test clear roles for non-clinicians and incorporate scalable and sustainable approaches to training and supervision, safety monitoring, and credentialing to complement and extend the mental health workforce are responsive. Task-sharing research should include collection of information useful to policy makers to develop credentialling or other system policies to support the non-licensed clinician if the model is found effective.

Purpose

This NOFO is intended to support research that addresses barriers youth and families encounter when accessing empirically-supported practices for mental health. NIMH seeks applications with high public health impact that will study methods to increase access to, and quality of, empirically-supported practices for youth mental health, including but not limited to: youth and families who are affected by health disparities; those who experiencing food insecurities, housing instability, and homelessness; and those living in rural areas, inner cities, and other under-resourced areas.. Applications may propose research related to optimizing assessment of risk and mental illness; optimizing and implementing prevention, treatment, and service interventions and strategies; overcoming challenges related to workforce shortages and wait lists for treatment; integration of treatment and preventive interventions into settings where youth are most likely to be identified as needing care (e.g., schools, pediatric medicine, community organizations, social services, and juvenile justice), and service interventions that address systemic barriers to access and quality of mental health care (e.g., structural, policy, organizational, value in terms of cost/financing, management). Projects may also test the impact of policies and practices, interventions to facilitate care transitions and continuity across settings, and interventions to improve linkages/coordination across systems.

Background

As many as one in eleven children and adolescents in the United States are diagnosed with a mental health disorder, yet only a fraction of  youth ever receive treatment. Unmet treatment need for child and adolescent mental health problems is often greatest among populations with health disparities, those living in rural and inner-city areas, and those who experience housing and food insecurity. These trends were exacerbated during the COVID-19 pandemic, leading the American Academy of Pediatrics, the American Academy of Child and Adolescent Psychiatry, and the Children’s Hospital Association to declare a national emergency, while the Office of the U.S. Surgeon General issued an advisory statement on youth mental health. In addition, the rate of suicide among youth increased 62% from 2007 to 2021, 105,000 youth were treated in an ED for self-harm injuries in 2020, and the age at first attempt is decreasing. Youth and families encounter many access barriers to high quality, empirically-supported mental health interventions and services. These barriers include: (1) empirically-supported interventions that are not scalable or suitable for delivery in community settings; (2) empirically-supported preventive and therapeutic interventions that are not optimally effective or do not address the needs of youth and families; (3) a workforce that is not prepared to deliver empirically-supported mental health interventions for youth; (4) a poorly distributed workforce that is disincentivized to accept insurance, particularly Medicaid; (5) system and service barriers, including discontinuities across settings where youth are identified and receive mental health services (e.g., fragmented services across schools, primary care, specialty mental health clinics; discontinuities as youth transition to adulthood); and (6) a lack of decision support tools and quality measures to guide the delivery of interventions and services.

NIMH seeks applications to investigate methods for overcoming these challenges. Studies must evaluate the impact of optimized interventions in the typical consumer when delivered by the typical clinician, coach, lay person, or other provider in routine practice or in non-mental health settings (e.g. schools, pediatric medicine, community organizations, social services, juvenile justice, online settings and social media platforms). Accordingly, deployment-focused research in response to this NOFO must 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 to 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.

Specific Areas of Research Interest

Studies that address the barrier of empirically-supported interventions that are not scalable or suitable for delivery in community settings (e.g., community mental health, schools, pediatric medicine, juvenile justice and other youth-serving settings), including but not limited to: 

• Optimizing and testing interventions and services that are scalable and can be delivered with fidelity using available resources and personnel in community settings (e.g., incorporating technology and other design features that enhance implementation and scalability, and prevent threats to fidelity).
• Optimizing multi-component interventions to identify critical content that drives outcomes and can be feasibly administered with fidelity in community settings. 
• Exploring how technology, including mHealth and social media platforms, can be used to enhance the reach or therapeutic benefit of interventions (e.g., provider-facing technology to guide delivery; youth- or parent-facing technology to supplement in-person therapy and promote between-session skills use) and the role these technologies play in the continuum of care.
• Leveraging multi-level, cross-sector partnerships among schools, businesses, health care systems, community-based organizations, and other community resources to advance the implementation and/or scale-up of effective mental health services across the continuum of services.

Studies that address the barrier of empirically-supported preventive and therapeutic interventions that are not optimally effective or do not address the needs of youth and families, including but not limited to: 

• Multi-modal, integrated, or augmentative intervention approaches (e.g., combination treatments, sequenced interventions, stepped interventions), that address factors associated with suboptimal response among treatment-refractory groups in order to enhance effectiveness.  
• Modular preventive and treatment interventions that are personalized, efficient, effective, and can be more flexibly and feasibly implemented.
• Optimized interventions that substantially improve intervention response, adherence, and/or engagement for racial and ethnic minority groups, individuals limited by language or cultural barriers, sexual and gender minorities, individuals with disabilities, individuals living in rural areas, groups that have been economically/socially disadvantaged, and other underserved groups. 
• The development, refinement, and testing of algorithms and strategies for identifying youth with and at risk for mental health disorders and for matching youth to interventions of appropriate intensity/dose, based on risk status or the severity of the mental health problem as well as the capacity of the youth or family to engage in services.   

Studies that address the barrier of a workforce that is not prepared to deliver empirically-supported mental health interventions for youth, including but not limited to: 

• Developing and testing scalable approaches, including technology-supported approaches to promote training to competence and sustained implementation fidelity in assessment and delivery of preventive, therapeutic, and services interventions.
• Examining how technology might be used as scaffolding to support providers in implementing evidence-based practices with sustained fidelity. 
• Task sharing models that propose and test clear roles for non-specialty providers, staff, peers, or lay persons and incorporate scalable and sustainable approaches to training and supervision, safety monitoring, and credentialing to complement and extend the mental health workforce.
• Developing and validating pragmatic strategies for monitoring the quality of preventive, therapeutic, and services interventions to facilitate efforts at training, supervision, and quality monitoring/improvement.
• Developing, testing, or comparing scalable models for supporting providers in the delivery of research supported services and preventing provider turnover and burnout (e.g., Extension for Community Healthcare Outcomes [ECHO], practice communities).  

Studies that address the barrier of a poorly distributed workforce that is disincentivized to accept insurance, including but not limited to:

• Comparative economic evaluations of alternative implementation strategies that might be used to foster the delivery of the continuum of empirically-supported services in schools and other naturalistic settings and/or across phases of implementation.
• Examining the effectiveness of specific crisis services in the context of alternatives, including comparative effectiveness and cost-effectiveness analyses, to promote implementation of high value services.
• Testing the effectiveness of reimbursement/payment models along the continuum of mental health services, including assessment of positive impacts and unintended consequences. 
• Identifying optimal incentives, including financial and other incentives, to encourage mental health providers to participate in insurance or in underserved areas.
• Modeling or comparing the impact and return on investment of alternative strategies for increasing the number of providers (e.g., training initiatives, recruitment strategies to ensure a diverse workforce).

Studies that address system and service barriers, including discontinuities across settings where youth are identified and receive mental health services, including but not limited to:

• Developing, optimizing, and testing interventions and implementation strategies to enhance continuity in youth mental health care across developmental transitions (e.g., the transition to adulthood for youth with autism, severe mental illness, etc.).
• Innovative interventions and implementation strategies to reduce disparities in service access, quality, and outcomes for racial and ethnic minority groups, individuals limited by language or cultural barriers, sexual and gender minorities, individuals with disabilities, individuals living in rural areas, groups that have been economically/socially disadvantaged, and other underserved groups. 
• Services interventions that can be used in non-mental health settings to promote detection, engagement, and facilitated referral of youth in need of mental health treatment (e.g., to Certified Community Behavioral Health Clinics or other mental health specialty services). 
• Navigator interventions to facilitate help-seeking, access, and engagement, and shared decision-making for mental health services or other services to meet social needs.
• Interventions (including technology-based approaches) aimed at the patient-, family-, provider- and/or systems-level factors to address practical, systemic, and cultural barriers to, and facilitators of, risk detection, referral, and treatment of self-injurious behavior (SIB) and/or non-suicidal self-injury (NSSI), with attention to developmental factors in the targeted age group. 
• Comparing state and local policies regarding age of consent for services to examine how policies and practices impact service access and use among youth.
• Evaluating and comparing alternate payment models (APM) (e.g., integrated care, Accountable Care Organizations, etc.) for youth-centered services that facilitate cross-sector coordination between mental health, primary care, other health care, and social service providers. Studies may also examine strategies for combining funding from multiple sources, including braiding, blending, sequencing, or other financing strategies.
• Interventions that utilize restorative justice approaches to address system- and structural-level factors that impact service access, use, and delivery, or risk and severity of mental illness.

Studies that address a lack of decision support tools to guide the delivery of interventions and services, including but not limited to: 

• Utilizing administrative data sources (e.g., electronic health records, claims data) and data science and commensurate analytic approaches (e.g., predictive analytics, machine learning, etc.) to identify mental health risk and optimize delivery of mental health care. 
• Development and validation of decision support tools to guide the selection of empirically-supported practices to  be offered within a given practice setting, including across multiple tiers (e.g., universal, selective, targeted prevention) based on the current need and available resources.
• Development and validation of decision support to guide decision making for matching youth to intervention(s) and service(s) of appropriate intensity and focus, given the nature and severity of the presenting concerns.
• Developing and validating tools for risk stratification that incorporate risk algorithms (e.g., EHR data, other routinely collected information, or screening responses) and can be used to guide decisions regarding the optimal level of care for youth exhibiting suicidal thoughts and behaviors. 

Scale and Scope of Research

This NOFO uses the R01 research project grant mechanism to support both pilot stage and full-scale research projects. The application should clearly specify the goals of the project and justify the methods (e.g., sample size, analytic strategy) and the requested resources (i.e., 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 potential to inform practice. Study designs may also address hypotheses regarding predictors and moderators of outcomes.

This NOFO 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.

Studies focused on intervention effectiveness and implementation strategies at the person 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 intervention effectiveness and implementation strategies at the person level, at least one hypothesized mechanism of action (confirmation of target engagement) is required. For studies focused on service/system level interventions, applicants should provide a conceptual model that justifies the empirical relationship between system interventions and strategies and outcome(s), and must 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 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. 

For studies that test the effectiveness of therapeutic or preventative mental health interventions and related implementation strategies at the person level, NIMH 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 cultural fit for specific populations, or is likely to encounter implementation challenges in routine care, school, 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).

NIMH encourages optimization of service-ready interventions that can readily be integrated into practice and incorporate features specifically designed to prevent threats to implementation fidelity (e.g., using consumer-facing or provider-facing technology, including technology to support provider training and sustained implementation with fidelity). NIMH encourages applications that include plans to quantify the time and resources required for provider training, supervision, and implementation of the intervention.

NIMH encourages studies that maximize efficiencies by utilizing existing infrastructure to facilitate data collection, enhance the sustainability of the approach, and improve the feasibility of participant recruitment. For example, existing infrastructure may include practice-based research networks, electronic medical records, administrative databases, patient registries, and routinely collected school data.

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 educational organizations, third-party payers, public mental health policymakers, 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 is expected. Preliminary data should reflect an existing partnership between academia and the system or service setting. Studies should capitalize on existing infrastructure (e.g., practice-based research networks such as the NIMH-supported Early Psychosis Intervention Network [EPINET]; NIMH-sponsored ALACRITY Research Centers or Suicide Research Centers; SAMHSA’s Certified Community Behavioral Health Clinics, Project AWARE [Advancing Wellness and Resiliency in Education] program, or other grantee networks;  NIH's Communities Advancing Research Equity for Health; public and private health care systems, school systems, electronic medical records, administrative databases, patient registries, institutions with Clinical and Translational Science Awards) to increase the relevancy of the system intervention and implementation strategies tested.

In accordance with the NIMH Strategic Framework for Addressing Youth Mental Health Disparities, NIMH is committed to supporting research that reduces disparities and advances equity in youth mental health interventions, services, and outcomes. As such, this NOFO encourages research that seeks to reduce disparities in outcomes for racial and ethnic minority groups (e.g., American Indian or Alaska Native, Asian, Black or African American, Latino or Hispanic, and/or Native Hawaiian or Pacific Islander youth), individuals limited by language or cultural barriers, sexual and gender minorities, individuals with disabilities, individuals living in rural areas, groups that have been economically/socially disadvantaged, and other underserved groups. This NOFO strongly encourages intervention and services research that includes plans to address drivers of disparities in mental health outcomes and that tests research-informed strategies that are relevant across diverse individuals.

Primary outcome measures should be validated, generally accepted by the field, and considered in context of NIMH's requirements for use of common data elements. 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 (such as school, employment, family, peer 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, preventive, and/or services approaches).

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 youth (i.e., ages birth to 25 years).
• 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 youth.
• Applications that propose to test interventions and service delivery in research settings rather than routine care, community, school, 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).
• For studies that involve developing and 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 developing and 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.
• 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.
• Studies focused on stigma or health literacy that examine knowledge about or attitudes towards mental health and mental health care without also examining mental health policy, actual service access, engagement, quality and/or outcomes of care.

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, accelerate recruitment, or increase sample diversity), 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 prevention and treatment of mental illness have the potential to reduce morbidity and mortality associated with suicide attempts and deaths (see https://www.hhs.gov/programs/prevention-and-wellness/mental-health-substance-abuse/national-strategy-suicide-prevention/index.html). 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 PhenX Toolkit | National Institutes of Health.

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 and Conducting Research with Participants at Elevated Risk for Suicide: Considerations for Researchers). 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.

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 to Goal 3 and/or Goal 4.  DSIR priorities and key areas of interest are regularly updated on the DSIR webpage. Applicants interested in 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, the NIMH webpage on clinical research

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

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

[email protected] 

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

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 the target populations; 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 well-powered 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 disparities 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 fully-powered 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 definitive 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: (1) 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); (2) an empirical explanation of how the prognostic variable interferes with the response to the un-adapted intervention; and (3) 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 person-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.
• 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, equitability, 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:

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

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) 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 Management and 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 diverse, 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.

As appropriate, applications may include materials related to intervention delivery or training of providers in this section. As relevant, this may include screenshots of mobile interventions, technological specifications, training manuals or treatment algorithms, as relevant. Videos are not allowable. Applicants must upload the attachments for Intervention Manual/Materials, as applicable. If more than one set of Intervention Manual/Materials are used, they should be combined in this attachment. Applicants must use “Intervention Manual/Materials” to name these other attachments files. 

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.

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 HIV-related human subjects research funded by NIMH. 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. The NDA Data Submission Cost Estimation Tool is available to facilitate the calculation of these costs.. NIMH may seek further information regarding CDEs prior to award. Details for HIV-funded NIMH research can be found at NOT-MH-23-105 and the NIMH webpage on Data Management and Sharing for Applicants and Awardees. 

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 NIMH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Videos are not allowed as post-submission material

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 NIMH, 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.

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

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

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:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
2. 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.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

For Treatment Interventions:

Marcy Burstein, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-9699
Email: [email protected]

For Preventive Interventions:

Mary Rooney, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-1325
Email: [email protected]

For Services Interventions:

Mary Acri, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-910-8230
Email: [email protected]

Nicholas Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]
 

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811  
Email: [email protected]
 

Section VIII. Other Information

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

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