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

Purpose

The mission of NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. The purpose of this notice of funding opportunity (NOFO) is to encourage exploratory (R33) grant applications that focus on psychosocial intervention development consistent with the NIMH emphasis on the experimental therapeutic approach for the treatment and prevention of mental disorders in adults and children. In this approach, clinical trials should be designed so that even negative results will provide information to guide further intervention development efforts. The focus of this NOFO is on the early phases of intervention development, during which emergent research on mechanisms and processes underlying mental disorders is translated into clinical hypotheses and novel interventions are tested in a clinical population or population at-risk.

Research Objectives

Targets may include, but are not limited to, potentially modifiable behavioral, cognitive, affective and/or interpersonal factors or processes, neural circuits or neural activity subserving specific behaviors or cognitive processes, and/or other neurobiological mechanisms associated with risk for, causation of, or maintenance of a mental disorder. Eligible psychosocial intervention strategies might include in-person or technology-assisted delivery (e.g. digital therapeutics), provided the target and/or the intervention strategy is novel. Digital technologies that meet the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act, may be accepted under this NOFO.  It is important to note that such digital technologies with the intended use of treating or preventing mental illness are FDA-regulated, even if they are non-significant risk (NSR).  In the case of technology-assisted delivery, if optimization of the technological aspects of the delivery is the focus of study, this would be more appropriate for PAR-25-184: “Early Stage Testing of Pharmacologic or Neuromodulatory Device-based Interventions for the Treatment of Mental Disorders (R61/R33 Clinical Trial Required).” This NOFO supports the development and testing of novel psychosocial interventions, as defined above, as monotherapies or as augmentations to a standard treatment (which may be psychosocial, pharmacological, neuromodulation, biologic, or other somatic modality). Studies must include an examination of a defined intervention target/mechanism based on empirical evidence of disease processes or mechanisms that confer risk, causation, or maintenance of a disorder, and a clear hypothesis about how an intervention directed at changing the target/mechanism can lead to clinical benefit in persons with or at risk for mental disorders.

This NOFO provides support for up to 3 years for studies to confirm target engagement in a larger sample, assess the relationship between target engagement and changes in measures of clinical benefit, and examine preliminary signal of efficacy. Results from the R33 should provide evidence to determine whether further development of the intervention is warranted, and if it is, to inform the design of a subsequent confirmatory efficacy trial. This NOFO encourages highly innovative projects, with the recognition that such projects may entail a greater failure rate (e.g., failure to reach pre-specified milestones for continued development). NIMH values this early, efficient, and objective testing of an intervention's ability to alter a well-defined and objectively measured target/mechanism to help inform decisions about which interventions should be further developed. 

Studies testing multimodal interventions (e.g., a novel psychosocial intervention designed to augment an established drug- or device-based intervention) are acceptable under this NOFO if the psychosocial intervention being tested is novel. A clear and careful description of the combination of therapies, and how the combination parameters will be assessed must be included. Studies must demonstrate how effects of the combined therapies on target engagement are positively synergistic (versus negative or net-neutral) or fill a gap left by the monotherapies, and use contextually appropriate comparison conditions (e.g., comparing the effects of the combined therapies relative to each monotherapy) when research methods allow for them. For all combination therapies, applicants should follow all other guidance/requirements of the NOFO including defining measures of target engagement and describing how they will test various doses/combinations. The rationale for the selection of doses/combinations being assessed should be well-supported by empirical evidence (i.e., preliminary data, clinical and/or preclinical studies, or existing evidence from the literature), a conceptual model, or rationale.

For multimodal interventions in pediatric populations, a novel intervention should be paired with a previously established intervention. For drugs and devices, an established intervention is defined through FDA approval/clearance of the intervention, for a specific indication, age range, and dosing.

Information about the mission, strategic plan, and research interests of the NIMH can be found at the NIMH website. Applicants are also strongly encouraged to review the information on the NIMH clinical trials website.

This NOFO is not intended to support research on novel (i.e., not established) pharmacological interventions or neuromodulatory devices, alone or in combination with other treatment modalities, nor is it intended to support research on the use of an FDA-cleared device outside of its intended use (e.g. using MRI to deliver neurofeedback). . For a detailed description of the appropriate NOFOs to support these areas of research, see a list of other NIMH clinical trials NOFOs in related announcements and reference the companion funding opportunities listed at the beginning of this NOFO.

NIMH Priorities for Developing and Pilot-testing Interventions

NIMH requires applicants follow an experimental therapeutic approach to develop and test interventions. Clinical trials following this approach should explicitly address whether the intervention engages the target/mechanism presumed to underlie the intervention effects (target engagement) and relates change in the target/mechanism to clinical benefit.

Targets

The term "target" refers to a factor that an intervention intends to modify, based on a hypothesis that modification of that factor will result in improvement of symptoms, behavior, or functional outcomes, or lower risk for the onset of mental disorders. Targets/mechanisms can range from molecular, neural, or neurophysiological systems to cognitive, behavioral, or emotional processes, to interpersonal/social group processes or contextual factors. A target may be a disease mechanism, a factor related to a disease mechanism, or a factor that confers significant risk. An appropriate target is an intervening variable that has either been demonstrated to be associated with risk for a mental disorder, with a clinical symptom or functional deficit, or is hypothesized (based on empirical evidence) to impact the biological or psychological pathway through which a clinical or functional benefit would be expected to occur. Thus it is hypothesized that change in the target will mediate the intervention's clinical or functional impact. While exposure to broad, societal/environmental circumstances might be used to identify at-risk populations, NIMH will not accept applications that propose to directly target or intervene on broad, societal adverse exposures, such as strategies to reduce poverty or violence. "Target engagement" refers to verification that the intervention has had the predicted effect on the target/mechanism. In the experimental therapeutic approach, once target engagement is demonstrated, measures of target engagement are then related to clinical outcomes to begin to test the hypothesis that modification of the target/mechanism is sufficient to alter the clinical outcome under study.

Valid and reliable measures of change in the target/mechanism will provide useful information about the potential for further development of the intervention. In the assessment of target engagement, NIMH encourages the use of measures that are as direct and objective as is feasible in the clinical research setting. NIMH encourages hypotheses and measures of potential mechanisms across molecular, biological, cognitive, psychological, affective, social, and/or behavioral domains of analysis that might account for change in the target and clinical outcome. The type of measures will depend on the conceptual model, the nature of the target mechanism, and the availability of valid, reliable measures of change in the target/mechanism. Measures might include self-reports, lab-based neurocognitive tasks or other behavioral measures, psychophysiological measures, neuroimaging or other brain-based measures, sensor-based or other observational measures of interpersonal processes or contextual/environmental factors, or valid proxy measures as alternatives. Specifically encouraged are empirically validated measures of the construct that extend beyond self-report and other subjective measures, where possible.

Tests of multiple targets/mechanisms are allowed when appropriate. Each proposed novel target/mechanism must be supported by an empirically-supported rationale, a testable hypothesis, and valid and reliable measures of change. Applications to evaluate more than one target should define their go/no-go criteria clearly, define milestones accordingly, and justify the decision to make proceeding to the next stage of intervention development contingent on the specified effect of the treatment on them. Applicants are strongly encouraged to review the information on the information on the NIMH website focused on clinical trials.

The clinical endpoint or outcome will vary according to the type of intervention. In the case of preventive interventions, the proximal target might involve a risk factor that has been associated with the etiology or onset of a MH disorder. Accordingly, the intervention's efficacy might be evaluated in terms of whether the intervention, mediated by changes in the target, resulted in decreased onset of the MH disorder/condition/phenotype (i.e., the clinical endpoint). Alternative conceptualizations might propose proximal targets/mechanisms that are intervening variables purported to be instrumental in reducing the risk state itself (i.e., with the clinical endpoint defined in terms of a reduction of risk).

Intervention Approaches

The primary purpose of this NOFO is to support the development of novel intervention approaches that involve novel strategies and/or novel targets. Novel intervention approaches must be theoretically supported and hypothesis-driven with an emphasis on why the novel approach is expected to substantially improve outcomes via engagement of the target/mechanism. NIMH is particularly interested in the development of novel interventions that focus on operationally-defined, empirically-supported functional domains or symptoms of mental disorders as opposed to broad diagnostic categories in which not all subjects may share the same underlying disease process. For example, NIMH Research Domain Criteria (RDoC) constructs may inform mechanism-based hypotheses and the selection of interventions, outcome measures, and clinical subjects. Intervention targets related to RDoC constructs are of interest for this NOFO, but other, non-RDoC constructs may be suitable as well, especially if they maximize the probability that these subjects share the same mechanism of disorder. However, applications that involve using a new assessment method or new level of analysis to better understand established mechanisms of an established intervention should submit mechanistic clinical trial applications under the parent R01 announcement; (see Support for Clinical Trials for more information about NIMH’s use of parent announcements for mechanistic trials).

While the principal purpose of this NOFO is to support the development of novel strategies, adaptations of efficacious interventions may be supported under specific conditions. Adaptations of existing interventions might be supported if they are based on empirical evidence suggesting that efficacy or specificity of the intervention could be substantially improved for a defined subpopulation of patients (e.g., non-responders) by engaging a novel target/mechanism (e.g., by engaging a target that has not previously been known to be critical or considered feasible to address in that subpopulation or disorder). However, applications that involve testing modifications of existing intervention approaches, for the purposes of extending the approach to new settings, for improving intervention adherence or engagement, or for intervening on provider-, system-, community-, or societal-/structural- level factors, are referred to NIMH NOFOs for effectiveness research (see NIMH Support for Clinical Trials).  NIMH also encourages the use of these effectiveness NOFOs for applications for refinement and testing of approaches that are primarily comprised of research-informed strategies that may not have been extensively tested in the proposed combination and for cases where there is strong pilot data and the goal is to conduct further testing in a community practice setting.

It is important to note that while this NOFO will support pilot testing of novel technology-assisted intervention approaches where the focus is on the psychosocial intervention being delivered, it is not intended to support the translation of existing efficacious treatments into technology-based applications (e.g., mHealth).

The purpose of studies supported by this NOFO is to replicate target engagement demonstrated in preliminary studies of the proposed intervention and to determine whether engaging the target affects clinical outcome(s) of interest. Studies supported by this NOFO should not be powered as definitive tests of clinical efficacy but rather should determine the magnitude of the relationship between changes in the target mechanism(s) and changes in clinical or functional outcomes in a clinical or at-risk population. In addition to the primary aim of linking target engagement and clinical benefit, secondary aims may include: 1) intervention refinement and standardization (e.g., further manual or protocol development along with fidelity scales); 2) further testing of the feasibility, safety, and acceptability of the intervention; 3) preliminary testing of the association between a change in the target/mechanism and clinical benefit; 4) evaluating the feasibility of recruitment, randomization (if appropriate), retention, assessments, and reporting of adverse events; and 5) developing measures of functional target engagement and of clinical benefit feasible for use in larger efficacy and effectiveness trials. The specific activities and intervention parameters appropriate for the study will depend on the type of intervention under study and the stage of the study proposed. The dosage/delivery parameters (e.g., number, frequency, and duration of sessions) of the intervention should be justified using preliminary data, other empirical data, and the conceptual model. The results of the study should inform a decision about whether the intervention shows the potential for improving clinical outcomes, including evidence of safety, acceptability, and feasibility, and a preliminary signal of efficacy, and regarding the strength of the association between target engagement and clinical benefit. The study should also inform the design of a subsequent confirmatory efficacy trial if indicated.

The number of trial sites should be limited to minimize variability of the data.

Areas of interest include, but are not limited to

• Studies that are highly innovative and address an unmet therapeutic need, or otherwise have the potential for substantially improving outcomes for people with mental disorders. Innovation is reflected in the choice of a novel target/mechanism or a novel approach to altering a known target/mechanism. Adaptations of efficacious interventions may be considered high priority if they are based on empirical evidence that efficacy or specificity could be substantially improved for a defined subpopulation of patients (e.g., non-responders, children) with a different intervention target/mechanism or different approach to the known target/mechanism.
• Studies based on a strong conceptual rationale, including empirical support, for choice of the target/mechanism and potential for the intervention to have an impact on that target/mechanism.
• Studies supported by preliminary evidence of target engagement and propose a rigorous test of target engagement to replicate the preliminary findings. The research strategy should utilize reliable, valid measures of target engagement, including dose and/or protocol optimization to definitively test the ability of the intervention to engage the target/mechanism.
• Studies that evaluate whether the intervention has therapeutic potential (feasibility, acceptability, and preliminary signal of efficacy), as well as other information needed to conduct a confirmatory efficacy (e.g., variability and sensitivity of measures, randomization methods) in a patient population.
• Studies that refine and pilot test the experimental protocol, methods, and measures. The study should utilize measures of treatment fidelity and psychometrically-sound outcome measures that capture changes in the disorder, functional domain, or symptom(s) within the context of a trial.
• Studies that examine whether intervention-induced changes in the target/mechanism are associated with changes in clinical symptoms or function, as predicted by the conceptual framework. Include other variables as appropriate that may inform an understanding of mediators and moderators of intervention effect.
   

Applications Not Responsive to this NOFO

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

• Applications whose scope of work does not include the measurement of intervention target(s)/mechanism(s), the choice of which is supported by empirical evidence of its potential role in the disorder or symptoms in question, and of its potential to address an unmet therapeutic need.
• Applications whose scope of work includes an initial test of target engagement.
• Applications whose scope of work does not address the intervention's ability to alter the target/mechanism (replicate the prior findings) in a larger clinical population.
• Applications that develop or evaluate pharmacological agents or biologics, or neuromodulatory devices.
• Applications whose scope of work includes nonhuman animal studies.
• Applications whose scope of work includes interventions that target or intervene on broad, societal adverse exposures, such as strategies to reduce poverty or violence.
• Applications whose scope of work includes examining novel pharmacological compounds, other biologics (e.g., nutraceuticals), or neuromodulatory devices.
• Applications whose scope of work is limited to the translation of existing interventions onto technology-based platforms (e.g., mHealth).
• Applications whose scope of work is focused on the use of an FDA-cleared device outside of its intended use (e.g. using MRI to deliver neurofeedback).
• Applications that add a new level of analysis to assess or better understand known mechanisms of an established intervention (e.g., a study that adds brain-based assessments such as imaging or psychophysiological measures) to evaluate underpinnings/correlates that are associated with changes in processes commonly targeted by established therapies

Other Considerations

Applicants are strongly encouraged to consult with NIMH staff when developing plans for an application (see Agency Contacts, Section VII). This early contact will provide an opportunity to clarify NMH policies and guidelines and discuss whether the proposed project is consistent with NIMH program priorities.

PD(s)/PI(s) submitting applications consistent with the experimental therapeutic approach but whose scope does not fall within that of the current NOFO are encouraged to contact Scientific/Research staff or go to the NIMH website providing information about clinical trials for researchers for further information.

Effective prevention and treatment of mental disorders have the potential to reduce morbidity and mortality associated with intentional injury (i.e., suicide attempts and deaths). Lack of attention to the assessment of these outcomes has limited our understanding regarding the degree to which effective mental health interventions might offer prophylaxis. Accordingly, where feasible and appropriate, applicants are strongly encouraged to include assessment of suicidal behavior in clinical trials in response to this NOFO using strategies that can facilitate integration and sharing of data (e.g., see NOT-MH-15-009 and https://www.phenxtoolkit.org/ for example constructs and corresponding assessment strategies).

Applicants are encouraged to leverage existing resources and infrastructure such as those provided by institutions with Clinical and Translational Science Awards (CTSAs) and/or other existing consortia/networks to promote efficient cross-disciplinary collaborations.

The NIMH is committed to enhancing the reliability of NIMH-supported research through rigorous study design and reporting (NOT-MH-14-004).

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 (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly. Plans for the protection of research participants and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• 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.

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: Provide a concise description of the exploratory clinical trial as well as how the proposed intervention could fill an important unmet need for those living with mental illnesses.

Research Strategy: 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: In this section of the Research Strategy:

• Describe the unmet mental health need that will be addressed by the intervention. Describe the intervention's potential to significantly reduce the burden of mental disorders.
• Propose a novel intervention with a strong, well-supported theoretical rationale that is ready for early-phase testing and/or propose an adaptation/extension of an intervention with established efficacy that will be used to test engagement of novel targets/mechanisms that have an empirically-supported rationale, a testable hypothesis, and psychometrically-sound measures of change.
• Propose clear hypotheses that are refutable. Describe how the project will advance knowledge of intervention and/or disease mechanisms, whether the trial results are positive or negative.
• Address the potential benefit of the intervention approach in terms of the clinical meaningfulness of the anticipated effect on clinical benefit and the clinical meaningfulness of the expected increment in clinical benefit compared to existing approaches.

Innovation: In this section of the Research Strategy:

• Provide a compelling scientific rationale for the approach chosen. Describe a novel, well-specified intervention target/mechanism and/or a novel approach to engaging an established target/mechanism.
• If the project concerns an adaptation or extension of an intervention with established efficacy, describe how the study will focus on novel targets/mechanisms. Describe how the approach would address an unmet mental health need (e.g., among a subgroup of individuals who are refractory to the standard intervention and/or in whom the efficacy of the intervention has not been established but who may share a common mechanism of disorder that it may usefully target).

Factor 2. Rigor and Feasibility

Approach: In this section of the Research Strategy: 

• Describe the elements of the experimental therapeutics approach to be used in the investigation. The elements critical to this approach are described in the specific requirements below.
• Clearly define each target/mechanism and the rationale for intervening on that target/mechanism, such as evidence that the target/mechanism is implicated in conferring risk, causing, or maintaining the functional domain or symptom(s) of interest and/or that variability in the expression of the target is associated with variation in symptom severity or presentation.
• Specify the objective, quantifiable, and reproducible measures of both target engagement and the intervention's clinical benefit that will be used.
• Describe how the study will rigorously test intervention target engagement. Describe hypotheses that are scientifically grounded and theory-driven about the hypothesized mediators, moderators, or mechanisms of the intervention's effect.
• Describe the protocol parameters that are relevant to configuring the intervention (such as intensity, duration, and/or frequency of sessions in some types of therapies; number, difficulty level and/or intervals between trials in computer-administered intervention applications; various other potential ways of specifying the intervention "dose") and how those parameters of the protocol will be optimized in order to convincingly test the intervention's capacity to engage the specified target.
• In the case of technology-assisted delivery, describe the protocol parameters that are relevant to configuring the technology (such as the software and algorithms) in sufficient detail that enables replication.
• Describe how associations between target engagement and clinical benefit will be evaluated. Describe how sufficient data will be collected in order to inform a decision about the therapeutic potential of the intervention for further clinical development. Provide the scientific rationale for the measures to be used and describe how each proposed measure will contribute to assessment of the relationships between intervention, target engagement, mechanism-based functional outcomes, and/or clinical benefit. Describe the selection of the control condition and how it is likely to contribute to addressing the research questions relevant to this phase.

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

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 allowed as post-submission material. Applicants must upload the attachments for Intervention Manual/Materials as separate files, 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. 

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.

Applicants Requesting $500,000 or more for direct costs (less consortium F&A) 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 to follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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

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

Post Submission Materials

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

Videos are not allowed as post-submission material.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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.

• 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]

Alexander Talkovsky, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-7614
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.