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

The purpose of this NOFO is to invite milestone-driven feasibility and infrastructure development (R61) research followed by a well-powered clinical trial (R33) to test the effectiveness of system interventions or strategies to improve the organization, delivery, coordination, and outcomes of mental health care for target populations. System interventions - which may span, for example, structural, policy, and organizational domains - attend to issues about the access, equity, engagement/utilization, value (cost/financing), management, or quality and safety of mental health services, with the goal of improved care processes and clinical, functional, and population level outcomes.  Accordingly, the focus of system interventions may include multiple factors/levels related to care delivered within or across a variety of care settings, such as health systems and organizations, mental health and community clinics, schools, and child welfare or juvenile justice systems.  Projects may, for example, test the impact of policies and practices, interventions to facilitate care transitions and continuity across settings, and interventions to improve linkages/coordination across systems.

Key Definitions for this NOFO

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, includes the manipulation of structural, organizational, or procedural factors and/or 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 those guided by the Collaborative Care Model and Coordinated Specialty Care.

Implementation strategy: One or more bundled methods or techniques designed to enhance the adoption of a therapeutic, preventive, or services intervention.  Examples include electronic clinical reminders, audit/feedback, training, and practice facilitation. Testing of implementation strategies is only appropriate in this NOFO when they target systems of care and/or multiple levels within a system or setting, rather than focus solely on the individual-level (e.g., service users or providers), and seek to improve (1) acceptability, satisfaction, and/or perceived fit of extant evidence-based practices and interventions, (2) access to, engagement with, and/or value of extant evidence-based practices and interventions, (3) quality and fidelity to evidence-based care, and/or (4) uptake, scalability, and sustainability of evidence-based practices or programs.

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, given typically available resources (e.g., trained, skilled providers), typical service and financing structures, and typical service use patterns, and that the study results have utility for end-users.

Background

Mental health services are delivered in the context of and informed by a complex system spanning multiple interconnected (and often mutable and adaptive) elements, domains, and processes. As such, system interventions differ from therapeutic interventions (e.g., treatment and prevention interventions) and many services interventions and implementation strategies.  In the latter case, the target recipient of the intervention or strategy is 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). In contrast, system interventions and implementation strategies target the system of care. The intervention focus could be on multiple organizational settings (e.g., primary and specialty care, community-based clinics and programs, academic settings, juvenile and criminal justice system, child welfare system, geriatric services) or multiple levels within a single organizational setting (e.g., patient-, provider-, clinic-, and health system-levels).  Examples of existing system interventions include the Collaborative Care Model and Coordinated Specialty Care.  Further, the system intervention could involve the manipulation of structural, organizational, or procedural factors and/or incorporate multiple implementation strategies to improve the delivery, effectiveness, and efficiency of mental health services. Approaches to test the effectiveness of system interventions and approaches to further understand how, why, for whom, and/or in which settings or under what circumstances the system interventions may be effective will differ from those used to study interventions that focus primarily on the individual.

Research Objectives

This NOFO utilizes the R61/R33 to support milestone-driven feasibility and infrastructure development research followed by a well-powered clinical trial testing the effectiveness of system interventions or strategies to improve the organization, delivery, coordination, and outcomes of mental health care for target populations. Milestones should be associated with clear, quantitative criteria for measuring success and efficacy that can be used for go/no-go decision making. 

R61 activities may include but are not limited to the following: development of research-practice partnerships with community and clinical collaborators, policymakers, and end-users; demonstrating feasibility of infrastructure (e.g., ability to acquire data from electronic health records); piloting components of the system intervention (e.g., workflow tools, screening measures, and/or integration of specific evidence-based interventions); and demonstrating feasibility and pilot effectiveness of recruiting and retaining participants for the trial and delivering the system intervention as intended.   

Contingent on meeting objective go/no go milestones set forth in the R61, the R33 phase will definitively test the effectiveness of innovative system interventions that aim to improve access, equity, continuity, quality, value, and/or clinical, functional, or population outcomes. Accordingly, the interventions - which may target and span multiple settings (e.g., community and practice clinics) and domains (e.g., structural, organizational, policy, broader health system) - should be designed with the intent to demonstrably improve factors such as mental health service organization, delivery, coordination, management, utilization, and, ultimately, clinical/functional outcomes. This NOFO also invites research testing multi- or system-level implementation strategies (i.e., not solely individual-level strategies, such as provider training in evidence-based practice(s)) to better scale and sustain preventive, therapeutic, and/or service interventions, with the goal of improved access, adoption, and outcomes for individual patients as well as target populations.

This announcement assumes that specific individual-level interventions or treatments that the system-level intervention is supporting already have sufficient demonstrated evidence of impact on a mental health condition. The research covered under this announcement is explicitly deployment-focused and should address practice-relevant questions. Research proposed in response to this NOFO should not only test the effectiveness of system interventions, but also must advance knowledge about how, why, for whom, and/or in which settings or under what circumstances the strategies may be effective.  System interventions that have the potential to substantially impact practice and public health in terms of the magnitude of likely improvements in key outcomes (e.g., access, equity, efficiency, or scalability potential), as compared to care as usual or dismantled versions of the system intervention, are encouraged.

Scale and Scope of Research

This NOFO invites only NIH-defined clinical trial research.  Projects that seek to study system-level interventions using non-clinical trial designs must apply through alternative NOFOs (e.g., https://grants.nih.gov/grants/guide/pa-files/PAR-23-095.html). Comparison conditions are strongly encouraged and should be well-justified, reflective of current practice, and, given the research question might include treatment-as-usual or enhanced treatment-as-usual.

NIMH is committed to supporting research that reduces disparities and advances equity in mental health interventions, services, and outcomes. Accordingly, this NOFO encourages system intervention trial research, such as testing innovative multicomponent service delivery models and implementation strategies, that take into account Social Determinants of Health (e.g.,neighborhood and built environment and socioeconomic stability) and seek to reduce disparities in service access, quality, and outcomes for racial and ethnic minority groups, individuals impacted by language or cultural barriers, sexual and gender minorities, individuals living in rural areas, socioeconomically disadvantaged persons and other underserved groups.

Applicants should provide a conceptual model that justifies the empirical relationship between system interventions and strategies and outcome(s). Applicants must also propose analyses that assess how the interventions and strategies are associated with and account for changes in outcomes. In the spirit of the NIMH experimental therapeutics approach, applications must employ relevant research methods that seek to understand how and/or in what circumstances the system-level intervention is effective. That is, methodology should go beyond assessing just whether an intervention is effective (or not), but what factors the system interventions are addressing to mitigate issues like access and quality barriers that contribute to the dampened positive impact we see when interventions are deployed in healthcare, community, and other settings. Potential approaches include but are not limited to mediation analysis (e.g., mediator mapping), moderator analysis, temporally organized dismantling designs, partial/fractional or full factorial designs, adaptive trials, etc.  Other methods to examine the direct effects of each of the intervention components on the ultimate intervention outcome (versus modeling such effects through target/mediator variables) could also be employed in this manner.

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, work, family, peer functioning) for children, adolescents, and adults, 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).

To facilitate 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, third-party payers, public mental health policymakers, front line clinicians, representatives from the affected populations) 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. Studies should capitalize on existing infrastructure to increase the relevancy of the system intervention and implementation strategies tested. Potential partners include: 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 (e.g., NOT-MH-22-170) and other grantee networks; NIH’s new primary care research network (https://commonfund.nih.gov/clinical-research-primary-care); institutions with Clinical and Translational Science Awards; or other infrastructure related to public and private health care systems, school systems, electronic medical records, administrative databases, and patient registries). 

Applicants are encouraged to contact Scientific/Research contacts (listed at the bottom of this NOFO; VII. Agency Contacts) 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 Goal 4. Both the Center for Global Mental Health Research (CGMHR) and Division of Services and Intervention Research (DSIR) priorities and key areas of interest are regularly updated on their respective web pages. 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 and the NIMH webpage on clinical research.

Areas of Interest Include, but Are Not Limited to:

• Trials testing multicomponent system- or service-level interventions that target different levels and sources of barriers to increase access and quality of mental health care and services. For example:
  • A multicomponent service intervention may combine strategies to support task sharing models in pediatric medicine that include provider level support, measurement-based care, outreach strategies, and customized interventions for the population of interest.
  • A system-level intervention may include the combination of measurement-based care, provider incentives, case-mix management strategies, and combined digital and human interventions to improve the delivery of interventions and mitigate waiting lists.
• Hybrid effectiveness-implementation trials testing the effectiveness of system interventions and implementation strategies focused on the organization or multiple levels within or across systems (rather than focusing solely on the individual level).
• Trials that leverage existing infrastructure (e.g., practice-based research networks, electronic medical records, administrative databases, patient registries, organizational processes), incorporate strategies/methods from emerging fields (e.g., data science, informatics, digital health, human factors or systems engineering), and subsequently test the effectiveness of system-level interventions as part of a learning healthcare system.
• Trials that test the relative contribution of constituent components of system-level interventions to overall effectiveness of existing multicomponent evidence-based service delivery interventions.
• Trials that incorporate modular or stepped-care approaches for matching service and treatment components of varying intensity to patient’s preferences or areas of greatest need across systems. For instance, studies may simultaneously or sequentially apply and coordinate targeted case management interventions and evidence-based care across settings serving populations experiencing social, financial, employment, housing, and food insecurities. Trials may also involve supported employment, psychiatric rehabilitation, or other social services that are integrated with behavioral health interventions.
• Trials that employ system- or service- level approaches to address potential sources of disparities in mental health care equity and quality within and/or across settings and domains (including determinants of health such as housing, social and community context, socioeconomic stability, and service delivery structure and access)  to improve mental health outcomes.
• Trials that employ a combination of provider-, organizational-, policy-, and other system-level interventions or implementation strategies to increase the uptake, fidelity, and sustained use of evidence-based mental health interventions.
• Trials that test strategies for optimizing and/or streamlining evidence-based mental health service delivery interventions for people with mental illness and other medical (e.g., cardiometabolic disease) or behavioral health (e.g., opioid use disorder) needs to improve adoption, contextual fit, scalability, affordability, and sustainability of integrated care.
• Trials that test financing and payment strategies, including alternative payment models, that incentivize the implementation and sustainment of evidence-based practices and their effects on clinical, functional, and health services (e.g., access, continuity, and equity of care) outcomes.

Applications Not Responsive to this NOFO

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 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 a detailed analytic plan and specify the variables to be measured. 
• Applications that propose to test interventions or implementation strategies in academic 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 (e.g., those that are not representative of typical practice settings or substantially impact generalizability).
• Applications that propose to test implementation strategies that focus only on the individual-level (e.g., provider training, coaching, or audit-and-feedback) 
• Applications that propose health literacy interventions without explicitly examining the impact on service access, engagement, quality and/or outcomes of care.
• Projects that do not involve a clinical trial (e.g., projects that do not use a clinical trial design to test the effectiveness of a system intervention)

Phases of the Award & Milestones 

This funding opportunity uses a R61/R33 Exploratory/Developmental Phased Award mechanism. Support cannot exceed 5 years, which includes the R61 phase (up to 2 years), followed by an R33 phase (up to 4 years) upon successfully meeting the R61 milestones. In this instance, the R33 is to test the effectiveness of system interventions with a fully powered design, and is not considered developmental. Applicants must provide a clear vision via objective milestones for how the research would progress if successful.

The R61 Phase

The R61 is a one- or two-year planning phase that will support activities that demonstrate feasibility. It is expected that work during this phase will largely focus on issues related to (1) collecting feasibility or pilot data for the R33 clinical trial, (2) engagement with end users to ensure buy-in, sustainability, scalability, etc.; (3) testing hypotheses for which preliminary data are not otherwise available; (4) demonstrating ability to access key datasets or build critical infrastructure; and (5) develop effective recruitment, retention and randomization methods. Applications must delineate milestones that signify the completion of major elements necessary to support a larger scale project in the second phase (e.g., successful piloting of an intervention or intervention component; accessing or improving timeliness of a specific dataset; establishing Memoranda of Understanding [MOU] with key end users, etc.).

The R33 Phase

The primary objective of the R33 phase is to definitively test the system intervention that was refined during the R61 phase. Specifically, the R33 phase will include an appropriately powered clinical trial testing the effectiveness of system interventions and/or implementation strategies.  For transition to the R33 phase, recipients must submit the transition package no less than two months before the completion of the R61 phase. The transition plan should include the R61 progress report describing in detail the progress towards the R61 milestones and a description of how research proposed for the R33 phase will be supported by the completion of the R61 phase milestones. These materials will be evaluated by NIMH program staff to determine if the milestones were met.

Transition to the R33 phase requires administrative review by NIMH staff and is not guaranteed. R33 funding decisions will be based on the original R61/R33 peer review recommendations, successful completion of transition milestones, any proposed changes to the R33 research based on R61 findings, program priorities, and availability of funds. It is expected that not all applications will continue to the R33 phase.

Other Considerations

Multi-site trials: This NOFO may be used to support 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.  

Mental health services applications: Support for hybrid effectiveness implementation clinical trials evaluating preventative, therapeutic, and services interventions where the recipient of the clinical intervention is the individual and/or the proposed implementation strategies focus only on the individual-level (e.g., provider training or support) is provided through PAR-25-177, “Full-Scale Hybrid Effectiveness-Implementation Trials for Mental Health Inventions (R01 Clinical Trial Required” and PAR-25-178, “Pilot Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 Clinical Trial Required.” Support for mental health services research not using a clinical trial design is provided through PAR-23-105: Innovative Pilot Mental Health Services Research Not Involving Clinical Trials (R34 Clinical Trial Not Allowed) and PAR-23-095: Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed).

Suicide-Related Outcomes: Effective prevention and treatment of mental illness have 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) 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.

Technical Assistance

NIMH intends to hold a web-based pre-application webinar for applicants to “Effectiveness Trials to Test Mental Health Systems Interventions (R61/R33 Clinical Trial Required”. Information on how to attend the optional webinar will be published through a Guide Notice.

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)

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

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

Timeline & Milestone Plan (Required - 2 page maximum)

Applicants should include a Timeline and Milestone Plan, clearly specifying proposed milestones and when those milestones are expected to be achieved. Milestones for both phases should be specified, though it is expected that R33 milestones may change based on results from the R61 phase for awards that transition to the R33 phase.

Stakeholder Engagement Plan (Required - 2 page maximum)

Applications should include detailed plans for engaging key stakeholders, including patients, families, providers, payers, and community leaders, as appropriate to the specific goals of their study.

SF424(R&R) Senior/Key Person Profile

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

R&R 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:

Specific Aims:

In the single page attachment allowed for the specific aims, provide an overview of the overarching research question of interest. Include clearly marked headers for R61 Specific Aims and R33 Specific Aims with brief descriptions of the aims specific to each phase of the study.

Research Strategy
Applicants must include the following sections as part of the Research Strategy. Applications should not duplicate information provided in the attachment described in PHS Human Subjects Clinical Trial Information form, but may reference it to provide context as needed.

Factor 1. Importance of the Research

Significance:

• Address a single set of research questions and goals, with the R61 phase establishing feasibility and necessary data to support transition to the R33 phase. Given the tight integration between the R61 and R33, only one Significance section is needed.
• Justify the potential public health impact of the system intervention in terms of the estimated hypothesized effect size (in terms of key outcomes, such as access, efficiency, or scalability), compared to already available interventions. Address the potential benefit of the system/service delivery approach in terms the clinical, functional, or population level meaningfulness of the anticipated increment in effects compared to existing approaches.
• Address the degree to which the proposed system intervention will be effective (e.g., includes evidence-based components), is scalable and could be disseminated into practice, given typically available resources (e.g., trained, skilled providers), typical service structures (including MH financing), and typical service use patterns.
• As appropriate, address the degree to which the proposed intervention addresses disparities in access, ongoing engagement, and/or clinical, functional, or population level outcomes.

Innovation:

• Highlight how innovative research strategies and design/analytic elements (e.g., adaptive sequential randomization, technology-based assessments, etc.) are incorporated, as appropriate, to enhance the study’s potential for yielding practice- and policy-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 system or service delivery strategy that is being evaluated.

Factor 2. Rigor and Feasibility

Approach:

• Detail separate Approach sections for the R61 and R33 phases. It is not necessary to repeat any information or details in the R33 section that are described in the R61 section. Include a Timeline & Milestone plan as an attachment as described in the SF424(R&R) Other Project Information. The approach sections may reference this attachment and should limit what is repeated from this attachment, except where necessary for clarity.
• 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 analysis (e.g., mediator mapping), moderator analysis, temporally organized dismantling designs, and partial/fractional or full factorial designs. 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.  
  • 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).
• Provide justification that the intervention is a system intervention that focuses on organization(s) or multiple levels within and across systems (versus a treatment, prevention, or service delivery intervention where the primary recipient is an individual).
• Describe how the setting (e.g., routine care, community practice, school, online) and staff characteristics are representative of typical practice.
• Describe provisions for the assessment and monitoring of the fidelity of intervention delivery via procedures that are feasible and valid for use in clinical and community practice settings.
• Describe design features that will be incorporated to help ensure that the approach can be feasibly implemented in practice, that it is scalable, and that it is robust against implementation drift (e.g., using technology as scaffolding or expert consultation via existing resources/other sustainable means to support delivery).
• Describe plans to involve collaborations and/or input from community practice partners/providers, consumers/service users, and relevant policymakers in a manner that informs the research (e.g., to help ensure the interventions/service delivery approaches are acceptable, appropriate, feasible, and scalable) and helps to ensure the results will have utility.
• Detail plans for using standardized measures to assess and examine consumer-, provider- and setting- level factors/characteristics that might be associated with uptake, implementation fidelity, and sustained use of the approach that is being tested. 
• As appropriate, detail plans to assess whether the intervention reduces disparities/promotes equity in access, ongoing engagement, and/or clinical or functional outcomes in individuals or target populations.
• Incorporate outcome measures that are validated and generally accepted by the field and are also applicable to the system(s)/services under study, including stakeholder-relevant outcomes (e.g., access, quality, value, patient functioning and health services use).  If NIMH’s common data elements cannot be incorporated, provide a strong justification.
• For studies that involve the assessment of patient-level outcomes, plans are expected 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. Accordingly, provide the rationale for the selection of suicide-related constructs and corresponding assessment instruments (e.g., measures of ideation, attempts), the time periods assessed (e.g., lifetime history, current), and the assessment schedule for administration (e.g., baseline, during intervention, post-intervention, follow up), taking into account the nature of the target population, participant burden, etc. Address 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 (e.g., services interventions that target provider behavior or systems-level factors), the target population (e.g., very young children), or unique issues related to participant burden or safety/monitoring concerns, the application should provide an appropriate justification for excluding these assessments.
• For the R61 Phase (Phase 1): Describe specific, quantifiable, achievable, time-bound, and scientifically justifiable milestones that will allow both program staff to assess progress in the R61 phase of the award and establish the feasibility or empirical basis for pursing the R33. Milestones should not restate R61 specific aims, or only reflect progress in terms of accomplishing tasks or in terms of the study timeline (e.g., meeting target enrollment). Milestones should include a description of specific, quantitative threshold values for any measures proposed for go/no-go decision-making.
  • Examples of Milestones/Deliverables for the R61 Phase:
    • Dates by which MOUs are fully executed and benchmarks for securing letters of support, data access or sharing agreements, and demonstration of active engagement and partnership as relevant to the goals of the study, including partnerships with departments, agencies, health systems, or end users that justify the feasibility of the R33.
    • Criteria/preliminary data demonstrating feasibility of the R33 phase, including but not limited to: recruitment, enrollment, and retention targets; benchmarks for demonstrating acceptability of and fidelity to research, assessment, data management, and/or clinical protocols; or, for applications where preliminary pilot data are not available, thresholds that would justify further testing of the proposed intervention in the R33 phase.  
• For the R33 Phase (Phase 2): Describe the methodology, including: a) the scientific rationale for the measure(s) used to assess the impact of the intervention; and b) the measure(s) and analytic plan proposed to assess the intervention’s effect on relevant clinical, functional, and population-level outcomes. Information on measurement validity and reliability should be included in the application. Describe measurement schedules. The approach should be summarized clearly in the application.

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 by NIMH under this 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 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 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 are used, they should be combined in this attachment.  Applicants must use the “Intervention Manual/Materials” to name these other attachments files. As appropriate, this may include screenshots of mobile interventions, technological specifications, training manuals or treatment algorithms.

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

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

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) do not need to 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 How to Apply-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. 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]

Division of Services and Intervention Research:

Shahrzad Mavandadi, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-827-1167
Email: [email protected]

Center for Global Mental Health Research:

Leonardo Cubillos, MD MPH
National Institute of Mental Health (NIMH)
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.