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:

Scalability: Scalability refers to features of the approach that support implementation fidelity. Strategies to enhance scalability include but are not limited to consumer-facing technology for intervention delivery and provider-facing technology for implementation support, training, or consultation.

Implementation strategies: Implementation strategies seek to improve (1) intervention acceptability, satisfaction, and perceived fit, (2) intervention access and engagement, (3) intervention quality and fidelity, and/or (4) intervention uptake and scalability.

Hybrid effectiveness implementation trials (hybrid trials): Hybrid trials include methods for evaluating intervention effectiveness and implementation factors. In hybrid trials participants are randomized to conditions at the level of the intervention, the level of the implementation strategy, or at both levels. In intervention settings where randomization is not feasible, a rigorous alternative may be appropriate. Hybrid type 1 trials emphasize evaluating intervention effectiveness while also assessing consumer-, provider- and setting-level implementation factors. Hybrid type 2 trials place equal emphasis on evaluating intervention effectiveness and the effectiveness of an implementation strategy related to the intervention. Hybrid type 3 trials emphasize evaluating implementation strategy effectiveness while also gathering patient or consumer outcome data to confirm intervention effectiveness.

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, scalable, can be disseminated into practice, 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.

Mechanism of action: A mechanism of action, or target mechanism, is a factor that an intervention intends to modify based on a hypothesis suggesting that modification will result in improved mental disorder risk, symptoms, or functional outcomes or enhanced implementation outcomes.

Purpose

NIMH seeks applications for pilot research to optimize and test the effectiveness of therapeutic or preventative mental health interventions and related implementation strategies in routine care, community, school, or online settings where individuals can readily access mental health services. This NOFO supports intervention development work when there is a compelling empirical justification for the proposed augmentation, optimization, personalization, or sequencing approach. This justification may be based on evidence that the unmodified intervention or strategy is associated with suboptimal clinical response, engagement, or adherence, is a poor 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). Online-only interventions may be appropriate for pilot development and testing when an existing sustainable infrastructure is available to continually connect consumers with the intervention and support ongoing maintenance and delivery outside the research enterprise. Studies that incorporate technology into the intervention design should align with NOT-MH-18-031: NIMH High-Priority Areas for Research on Digital Health Technology to Advance Assessment, Detection, Prevention, Treatment, and Delivery of Services for Mental Health Conditions.

Scale and Scope of Research

NIMH supports pilot research to optimize, personalize, or sequence preventative or therapeutic interventions and related implementation strategies in accessible settings where individuals can feasibly be connected to mental health interventions. With appropriate justification, this NOFO may support effectiveness research in the absence of extensive efficacy data. This includes, but is not limited to, studies of interventions comprised of research-informed strategies that have not previously been tested in combination or with the proposed target population, or interventions with strong pilot efficacy data that can be used to justify deployment-focused research as a logical next step to expedite the translation of research into practice.

Proposed pilot research must include plans to assess the feasibility and acceptability of the modified approach in the intervention setting, conduct a preliminary evaluation of the intervention or implementation strategy’s impact on the outcomes of interest, and explore the intervention’s impact on at least one hypothesized mechanism of action. NIMH encourages pilot research that also seeks to establish the feasibility and acceptability of research methods that may be applied in a future well powered clinical trial. Given sample size limitations, applications are not required to include effect size estimates or plans for well-powered mediation or outcome analyses. 

Proposed pilot research may include plans for deployment-focused development and testing that span a series of three steps. Step 1: systematically evaluate of the characteristics of typical intervention consumers, providers, and the intended delivery setting and obtain feedback from community and practice partners. Step 2: operationalize and develop the experimental intervention or implementation strategy and iteratively refine the approach within the context of a case series or similar methodology (e.g., to establish dosing, refine intervention manuals and training materials). Step 3: conduct a pilot hybrid trial to generate preliminary outcome and implementation data as a prerequisite to a fully powered hybrid trial. Applications submitted in response to this announcement must include Step 3 at a minimum and may also include any of Steps 1 – 2 as appropriate.

Applications must include a hybrid trial design that proposes to simultaneously evaluate (1) the clinical impact of the intervention on symptoms, functional outcomes, or risk factors associated with a mental disorder, (2) implementation factors or strategies that impact intervention access, engagement, or sustainability, and (3) at least one hypothesized mechanism of action. The proposed pilot development work must incorporate the perspectives of community and practice partners and address characteristics of the implementation setting. NIMH encourages pilot hybrid trials that maximize efficiencies by utilizing existing infrastructure to facilitate data collection, enhance the sustainability of the approach, and improve the feasibility of participant recruitment. Examples of existing infrastructure include practice-based research networks, electronic medical records, administrative databases, patient registries, and routinely collected school data. Consistent with NIMH’s commitment to supporting research that reduces mental health disparities and advances health equity, this NOFO strongly encourages applicants to include plans to address drivers of disparities in mental health outcomes and include strategies to optimize interventions in under-resourced settings and across racial and ethnic, sexual and gender minority, geographical, and socioeconomic groups.

Consistent with the NIMH experimental therapeutics approach, this NOFO requires trial designs that include a preliminary evaluation of a hypothesized mechanism of action. Applications must specify (1) at least one hypothesized mechanism of action for the intervention and/or implementation strategy, (2) measurement plans designed to feasibly assess the mechanism of action and primary outcomes in the intended intervention setting, and (3) an analytic plan designed to evaluate both changes in the mechanism of action and the association between changes in the mechanism of action and the primary outcome(s). The nature of the proposed mechanism will vary depending on the characteristics of the experimental intervention or implementation strategy. For preventive and therapeutic interventions, mechanisms include factors that have been empirically associated with mental disorder risk, etiology, maintenance, or severity. These might involve specific psychological, behavioral, or interpersonal processes or neurobiological entities. For implementation strategies, mechanisms may include mutable consumer- or provider- behaviors or intervention delivery approaches that are intervened upon to improve intervention access, engagement, quality, fidelity, or scalability.

Proposed measures of mechanisms and primary outcomes should be validated, accepted by the field, and considered in context of NIMH's expectations for the use of common data elements. At times a validated measure may not be available for a proposed mechanism of action or a proposed study population. In these instances, applications should provide a justification for the selected unvalidated measure and propose plans to further validate the measure as part of the pilot research methods. NIMH encourages the use of measures that are as direct and objective as is feasible in the intended intervention setting and/or span more than one level of assessment when appropriate. Examples include behavioral observation data, computer-based tasks, electronic health records, or other administrative sources. As appropriate, study designs may include Research Domain Criteria (RDoC) or RDoC-like constructs when defining the participant inclusion, mechanisms of action, and outcomes.

Applicants are encouraged to contact Scientific/Research contacts (see Section 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. DSIR priorities and key areas of interest are regularly updated on the DSIR web page. Additional priorities for intervention research are detailed in the "NAMHC Workgroup Report "From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illnesses." 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.

Areas of interest include, but are not limited to:

• Multi-modal or integrated intervention approaches, such as combination treatments or sequenced pharmacological, psychosocial, and/or neuromodulation interventions, to evaluate if combination or sequencing results synergistic effects on outcomes.
• Effectiveness and implementation of best practices for youth mental health in school, juvenile justice, foster care, pediatric medicine, and other settings serving youth.
• Effectiveness and implementation of best practices for older adults served through accessible settings and providers.
• Interventions that utilize social media and other digital technology to facilitate or augment service delivery.
• Innovative interventions and implementation strategies that seek to reduce mental health disparities in intervention access, quality, and outcomes for racial and ethnic minority groups, individuals limited by language or cultural barriers, sexual and gender minorities, individuals living in rural areas, groups that have been economically/socially marginalized, and other underserved groups.
• Personalized, modular or stepped-care approaches for matching treatment components of varying intensity to patient preferences or areas of greatest need.
• Augmentation strategies for treatment-refractory groups that are designed to address factors empirically linked with suboptimal response.
• Approaches that incorporate risk information to stratify and assign participants to preventive interventions in routine care, school, or community settings.
• Patient- and provider-level interventions designed to promote service access, use, engagement, and retention or improve quality or outcomes of care.
• Provider-level interventions, such as training and supervision approaches, to increase the uptake, fidelity, and sustained use of evidence-supported interventions.
• 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.

Applications Not Responsive to this NOFO

Studies that are not responsive to this NOFO and will not be reviewed include the following:

• Applications that do not propose a hybrid effectiveness implementation trial design.
• Applications that propose to test interventions or implementation strategies 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.
• Applications that do not propose an evaluation of the mechanism(s) of action and its impact on the primary outcomes, including the following components section of the application: (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) a description of the analytic plan for evaluating whether intervention-induced mechanism(s) of action are associated with outcomes. 
• Applications that propose adaptations of existing interventions without a compelling empirical justification.
• Applications that use patented medications that lack superior efficacy or safety relative to currently available off-patent medications.
• Applications that propose to test health literacy interventions without explicitly examining the impact on service access, engagement, quality and/or outcomes of care.
• Applications that propose to evaluate service level interventions that incorporate multiple implementation strategies to increase access, use, reach, adoption, and implementation of mental health services.

Other Considerations

Full scale hybrid implementation effectiveness trial applications: Support for well powered hybrid implementation effectiveness trials is provided through PAR-25-177.. 

Mental health services applications: Support for clinical trials evaluating service level interventions that target system-level factors or incorporate multiple implementation strategies to increase access, use, reach, adoption, and implementation of mental health services is provided through PAR-25-285: Effectiveness Trials to Test Mental Health System Interventions (R61/R33 Clinical Trial Required). Support for mental health services research not using a clinical trial design is provided through PAR-25-284: Innovative Pilot Mental Health Services Research Not Involving Clinical Trials (R34 Clinical Trial Not Allowed) and PAR-25-283: 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 (see www.suicide-research-agenda.org). 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 https://www.phenxtoolkit.org/).

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 subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.

Technical Assistance

NIMH intends to hold a web-based pre-application webinar for applicants to PAR-25-178 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.

Facilities and Other Resources: The description of the resources and environment should address how the study utilizes existing infrastructure (e.g., CTSAs, practice-based research networks, electronic medical records, administrative databases, patient registries) or utilizes other available resources to increase the efficiency of participant recruitment and data collection or provide a justification in the event that such efficiencies cannot be incorporated. 

SF424(R&R) Senior/Key Person Profile

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

In the biosketch, describe Senior/Key Personnel experience and expertise at collaborating with community practice partners/providers, consumers, and relevant policy makers to conduct effectiveness studies, as appropriate 

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: The Research Strategy must include the following information. 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:

• Justify the practical effect on public health of the intervention or service approach in terms of the magnitude and clinical meaningfulness of the anticipated effects on the key outcomes (e.g., clinical benefit, safety/tolerability, value and efficiency, or scalability), compared to existing approaches.
• Address the degree to which the proposed intervention or implementation strategy is scalable and could be disseminated into practice, given typically available resources (e.g., trained, skilled providers), typical service and financing structures, and typical service use patterns.
• 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.
• As appropriate, address the degree to which the proposed intervention 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, in order 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:

• Detail the plan to explicitly address whether the intervention engages the one or more mechanisms of action. Include the following:
  • A conceptual framework that clearly identifies the mechanism of actions and the empirical evidence linking the mechanisms 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).
  • The plans for assessing preliminary engagement of the mechanism(s) and outcome(s), the assessment schedule, and evidence regarding the validity and feasibility of the proposed measures in the effectiveness context.A statistical analysis plan for exploring whether intervention-induced changes in the mechanism(s) are associated with changes in the outcomes. The Research Strategy section of the application must include a description of this planned analytic approach, whereas the full details of the proposed statistical methods should be included in the PHS Human Subjects and Clinical Trials Information Form.   
• In the case of multicomponent 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.
• Articulate the process for determining the intervention's initial degree of "fit" and the iterative process that will be used to adapt/refine the intervention or implementation strategy. 
• Describe provisions for the assessment and monitoring of the fidelity of intervention delivery via procedures that are feasible and valid for use in the community setting. 
• Describe design features that will be incorporated to help ensure that the approach is feasible, scalable, and robust against implementation drift in the community setting  (e.g., using technology as scaffolding or expert consultation via existing resources/ other sustainable means to support delivery).
• 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, and to ensure the results are compelling to and have utility for end-users.
• Consistent with hybrid effectiveness implementation methods, describe plans for using standardized measures to assess and examine consumer-, provider- and setting- level factors that might be associated with uptake, implementation fidelity, and sustained use of the approach.
• Incorporate outcome measures that are validated and feasible in the effectiveness context, including stakeholder-relevant outcomes (e.g., functioning, health services use).
• For studies proposing adaptations of existing interventions, provide the empirical justification for the proposed adaptation based on data describing characteristics of client subgroups, settings, care providers or other relevant variables that are associated with non-response, partial response, relapse, or poor uptake (see page 19 of NAMHC Workgroup Report "From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illnesses."). Justify the adaptation in terms of (a) theoretical and empirical support for the adaptation target (e.g., a prognostic variable such as a neurocognitive functioning variable, that has been associated with non-response, partial response, patient non-engagement, or relapse); (b) a theoretical/empirical explanation of how the prognostic variable interferes with the response to the un-adapted intervention (i.e., a clear hypothesis regarding the mechanism by which the prognostic variable moderates response to the un-adapted intervention or functions to disadvantage a subgroup); and (c) evidence to suggest that the adapted intervention will result in a substantial improvement in response rate, speed of response, efficiency or other aspects of care, or uptake in community/practice settings when compared to the un-adapted interventions or existing intervention approaches.
• As appropriate, detail plans to assess whether the intervention reduces disparities in access, ongoing engagement, and/or clinical or functional outcomes.
• 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 and https://www.phenxtoolkit.org/ for constructs and corresponding assessment strategies), as appropriate, or provide a rationale for excluding such measures if they are not included. Accordingly, the application should 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. The application should also 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.

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.

The following additional instructions must also 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

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 this 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.

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

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

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

Post Submission Materials

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

Videos are not allowable 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 policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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 Studies involving therapeutic and preventive interventions:

Joel Sherrill, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-2477
Email: [email protected]

For Studies involving services interventions:

Michael Freed, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3747
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.