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 SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) 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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background:

Suicide is preventable; however, it is the second leading cause of death for youth ages 10-14 years in the United States. Despite rising awareness and alarm from many sectors, youth suicide trends continue to increase. From 2007–2017, the suicide rate for youth ages 10-24 rose from 6.8 per 100,000 to 10.6 per 100,000, representing a 56% increase. While overall suicide rates declined in 2018-2020, rates for persons age 10-24 have continued to increase. Suicide among Black youth has been increasing at a faster rate than other racial/ethnic groups, and American Indian/Alaska Native (AI/AN) youth are at much greater risk for suicide compared to same-aged White peers. Rural and LGBTQ youth are also at greater risk for suicide. In addition, these vulnerable groups of youth face many barriers to quality mental health care and suicide crisis services.

There is a growing body of literature reporting on the benefits of preventive interventions (e.g., substance use prevention, interventions that aim to prevent internalizing/ externalizing behaviors) delivered early in life, on long-term mental health and substance use outcomes. Research findings demonstrate that (1) intervening early in development and targeting proximal risk and protective factors can have an impact on a broad array of distal outcomes; and (2) preventive interventions can have unanticipated beneficial effects on outcomes not specifically targeted by the intervention (cross-over effects). Indeed, there is a small body of evidence providing proof of concept that preventive interventions aimed at reducing a number of risk factors for suicide (e.g., substance use, externalizing, and internalizing behavior, dysfunctional family communication) can prevent STB. New technological and analytic approaches for integrating and harmonizing data sets hold potential for increasing statistical power and facilitating the detection of the impact of prevention interventions, in general, among important subgroups (e.g., sexual gender minority youth, racial/ethnic minority youth), and in the case of low base rate behaviors (e.g., psychosis, suicide ideation and behaviors). Previous initiatives focused on aggregating data sets (e.g., addressing long-term and cross-over effects of prevention interventions) have yielded important findings. However, few studies have sufficient sample sizes to answer whether there is an impact on later suicide morbidity and mortality as primary outcomes. Ultimately, empirical evidence is needed to determine whether and under what conditions interventions delivered early in life mitigate suicide risk.

Since youth suicide death is a highly significant but low base rate behavior, detecting the effects of preventive interventions delivered early in life requires large numbers of subjects and lengthy follow-up. Aggregating data sets allows for the examination of low base rate behaviors and also allows for analyses on subgroups; existing datasets typically do not have sufficient sample sizes, inclusion of underrepresented populations, or power to answer these questions in isolation. Having a large well-characterized integrated prevention trial dataset will facilitate answering the question regarding when and how preventive interventions implemented early in life reduce risk for suicide death, attempts and thoughts, at which stage of development, for whom, and under what conditions. Importantly, prevention trials of interest for this FOA should be grounded in research and theory and should specify and assess hypothesized mechanisms of action for the interventions; as such, data from these trials allow for exploration of mechanisms by which interventions might reduce risk for suicide.

Purpose/Research Objectives

The purpose of this Funding Opportunity Announcement (FOA) is to encourage research to integrate/harmonize existing large prevention trial data sets implemented earlier in life to examine whether they reduce risk for later suicide, including suicide thoughts and behaviors—fatal and nonfatal (STB), and related external injuries (e.g., nonfatal SUD/OUD/accidents, and all-cause mortality (e.g., National Death Index). This U01 will be competed and funded to: 1) obtain existing prevention trial data sets, with collaboration of the PIs who have rights to the original data sets; 2) anonymize and aggregate and harmonize prevention trial data sets; 3) utilize advanced computational/analytic strategies to examine whether intervening early reduces risk for STB and mortality, and using theory-based approaches, examine potential mediators and moderators of outcome trajectories; and 4) oversee preparation of a final harmonized prevention trial data that will be deposited into the NIMH Data Archive (NDA). This harmonized dataset will serve as an enduring resource to the research community.

The FOA seeks to support data integration, harmonization, and analysis to examine questions regarding the impact of preventive interventions delivered earlier in life on suicide risk and mortality outcomes. The goal is to support the integration and harmonization of data from prevention trials involving interventions at different points in development, with different intervention targets, and with different prevention strategies to examine questions regarding when and how it might be possible to intervene earlier in the life course to address proximal risk and protective factors that are likely to have effects on suicide morbidity and mortality and to examine potential moderators of effects (e.g., intraindividual differences; family, peer, school, and community contexts; and parameters of the intervention delivery). This FOA also encourages the examination of mechanisms by which interventions confer benefit; information about intervention targets and strategies that are most strongly associated with preventive effects could be used to refine preventive interventions to enhance their potency and efficiency. Ultimately, the results of this research will contribute to an evidence base that can be used by researchers to inform the development of optimized intervention strategies and by agencies and communities to guide efforts to reduce the risk for suicide morbidity and mortality.

NIMH is committed to supporting research that reduces disparities and advances equity in mental health interventions, services, and outcomes. Projects that include the integration of prevention data sets can increase analytic opportunities to better understand suicide risk among racial/ethnic minority groups, sexual and gender minorities, individuals living in rural areas, individuals from socioeconomically disadvantaged backgrounds, or other underrepresented groups. Such knowledge can be used to improve access to preventive and treatment intervention services, improve youth and adult mental health trajectories throughout the lifespan, and facilitate mental health equity.

NIMH encourages the use of state-of-the-art computational approaches. For applications that propose data harmonization and analytic/computational approaches for which there is limited feasibility information, a sound rationale should support why the proposed approach is the most appropriate and likely to generate an exceptionally high impact if successful.

Given the expectation that multiple datasets will be aggregated, there should be a clearly documented commitment by the data owners, and the informed consent documents should permit such aggregation as well as depositing the primary data into the NIMH Data Archive. The awardee will be expected to sign the NIMH Data Archive Data Submission Agreement that allows the PI and the Institution to deposit a single harmonized data set. Consultations with relevant Institutional Review Boards may be helpful. This FOA is focused on the integration and harmonization of databases where data can be publicly shared. The NIMH Data Archive is willing to work with applicants to determine what data can be shared (e.g., National Death Index acquired data).

Protection of Human Subjects: 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. The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-19-027). The application’s Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice. 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.

Scale and Scope of Studies Covered Under this Announcement

This FOA utilizes the U01 mechanism to support the integration and analysis of existing data sets from preventive intervention trials implemented earlier in life - prenatal through adolescence (before birth through age 18 years) to examine risk for later suicide, including suicidal thoughts and behaviors—fatal and nonfatal (STB), and related external injuries (e.g., nonfatal SUD/OUD/accidents, and all-cause mortality (e.g., National Death Index; NDI). It is expected that NDI searches will be conducted; see NOT-OD-20-057; Notice of Information: National Death Index Linkage Access for NIH-Supported Investigators).

The size and scope of the resultant integrated dataset should be large (i.e. thousands of participants) and broad. NIMH encourages applications that assemble and analyze data from a range of preventive interventions, to allow for the examination and comparison of approaches that involve intervening at different points in development, with different intervention targets, and with different prevention strategies. The goal is to assemble a dataset that incorporates data across trials that employ a variety of prevention approaches to support analyses that will inform future research and policy regarding when and how to intervene early in children’s lives to reduce the risk for suicide in an efficient and cost-effective manner. The size and scope of the harmonized dataset should also be justified based on requisite power for examining the question of whether preventive interventions implemented early in life reduce suicide risk and related questions about intervention mechanisms and preventive effects among subgroups, including groups who experience health disparities.

Detail the rationale and sampling strategy for identifying and selecting prevention trials for inclusion in the integrated data set, in terms of the empirical/theoretical basis suggesting the preventive interventions would have relevance for preventing STBs in later life, the trial design/methods, and the assessment of relevant putative intervention mechanisms and STB outcomes in the original data collection. The overall approach to analyzing the integrated data set should be theory-based; the application should specify and justify the outcomes being studied and the hypothesized mechanisms of action to be examined (i.e., the putative mechanisms by which the preventive interventions impact later risk for STBs).

Examples of responsive research include, but are not limited to, studies that:

• Examine whether early preventive interventions (e.g., home visiting, family- or school-based prevention interventions) that address known risk factors (child abuse and neglect, growing up in early adverse circumstances, bullying) reduce suicide risk in later childhood, adolescence, and adulthood.
• Combine data from school-based social and emotional learning prevention trials at different stages of development to determine whether they increase protection and reduce suicide risk.
• Aggregate prevention trial data sets focused on underrepresented populations to examine whether implementation of developmentally focused, culturally relevant, and resilience-focused preventive interventions reduce suicide risk.
• Combine school-based prevention trial data sets (e.g., social emotional learning (SEL) programs, substance use prevention, positive behavioral intervention and supports (PBIS)) to examine whether they reduced risk for suicide ideation and behaviors, including suicide.
• Test whether various preventive interventions, including, but not limited to, interventions focused on preventing substance use, misuse and disorder, lead to reduced risk for STB as well as overdose morbidity and mortality.
• Combine data from prevention trials focused on ameliorating risk associated with early adversity and/or trauma in childhood (e.g., parental death or divorce, child abuse and neglect), along with data from trials with other prevention goals (e.g., data from trials that address risk for behavior problems or substance misuse/abuse) to examine the longer-term impact on STB.
• Capitalize on larger samples in integrated data sets to examine moderators of response and the impact of prevention interventions on suicide outcomes in racial/ethnic minority populations, sexual and gender minority populations, and rural youth.

Non-Responsive Areas of Research

Applications proposing any of the following research topics will be identified as non-responsive and will not be reviewed:

• Applications that do not focus on the integration and re-analysis of existing data sets from preventive intervention trials implemented earlier in life (prenatal through adolescence) to examine risk for later suicide, including suicide thoughts and behaviors—fatal and nonfatal (STB), and related external injuries (e.g., nonfatal SUD/OUD/accidents, and all-cause mortality (e.g., National Death Index).
• Applications that propose the collection of new data rather than harmonization and analysis of existing data.
• Applications that propose analysis of data from a single study/trial or parallel analyses of separate studies/trials.
• Applications that propose integration of data from trials focused on a single intervention approach, rather than from a range of preventive interventions.
• Applications that propose analyses of existing integrated data sets without proposing to create an expanded, harmonized data sets.
• Applications that propose to use data from trials that did not include appropriate consent to permit aggregating and depositing the primary data into the NIMH Data Archive for sharing of the dataset with the broader research community.
• Applications that do not include plans to incorporate data from NDI searches.

Potential applicants are strongly encouraged to consult with NIH staff as early as possible when developing plans for an application (see Scientific/Research Contacts, Section VII). This early contact will provide an opportunity to clarify NIH policies and guidelines and help to identify whether the proposed project is consistent with NIMH program priorities and goals.

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 FOA.

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 Government

• 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 Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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 registration; 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 his/her 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.

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 SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

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 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 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 FOA. 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 SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement 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: NIMHpeerreview@mail.nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy:

Research supported through this FOA must focus on integrating and harmonizing existing large prevention trial data sets implemented earlier in life to examine whether they reduce later suicide risk, including suicide thoughts and behaviors—fatal and nonfatal (STB), and related external injuries (e.g., nonfatal SUD/OUD/accidents, and all-cause mortality (e.g., National Death Index). The following elements must be included in the application: 

Significance:

• Detail how the results will advance understanding of whether prevention interventions delivered earlier in life have an impact on suicide risk and mortality outcomes. Address the potential for informing understanding regarding preventive effects among understudied populations and for advancing knowledge regarding when (e.g., at which stage of development) and under what conditions early intervention can confer protection.
• Describe how the proposed research substantially advances understanding above and beyond the original analyses and results of the prevention trials that are included as part of the current project (how does the proposed research substantially extend beyond current and previous federally and privately supported activities?).
• Detail how the results will advance understanding regarding key targets or change mechanisms that account for broad and sustained outcomes and moderators of response, and accordingly, how the results might be used to guide future efforts at intervention refinement and/or deployment.

Investigators:

• Detail the investigative team’s expertise related to integrating prevention trial data sets and other relevant data (e.g., data from the National Death Index, other administrative data).
• Describe the proposed study team's expertise and experience with the proposed analytic and computational approaches.
• Address the team’s expertise related to examining intervention outcomes and cross-over effects (unanticipated beneficial effects), including expertise relevant to suicide prevention.

Innovation:

• Describe how the proposed research utilizes novel, transformative approaches that leverage and aggregate existing prevention datasets to advance our understanding of the long-term and cross-over effects of prevention interventions on suicide risk.

Approach:

• Detail the rationale and sampling strategy for identifying and selecting prevention trials for inclusion in the integrated data set.
• Specify the cross-over and long-term outcomes that will be examined, describe how these key outcomes were originally assessed in the original prevention trials, and detail plans for how these outcomes will be operationalized for the current analyses, including data from the NDI.
• Describe strategies that will be used to harmonize data across trials, including plans that will be used to integrate data from trials that used different measures to assess the same construct and/or to derive latent variables for key constructs of interest that were not directly assessed.
• Detail strategies that will be used to examine data across trials that involve intervening at different points in development, with different intervention targets, and with different prevention strategies to address questions regarding when and how to intervene to reduce risk and STB.
• Detail plans to examine change mechanisms and mediators that might account for suicide risk outcomes and sustained effects.
• Describe the characteristics of the samples with regard to gender, race, ethnicity, and developmental stage. Address plans for examining moderators of response and for examining differential impact of the interventions across subgroups, as appropriate.
• Provide detailed power analyses for key aims, including power for analyses that address cross-over- and long-term- outcomes, analyses to identify key change mechanisms (e.g., changes in targeted self-regulatory skills, family processes) or other mediators of effects (e.g., implementation fidelity, dose), and analyses to identify moderators of response and/or explore subgroup analyses.
• Provide documentation that appropriate consent to was obtained to permit aggregating and depositing the primary data into the NIMH Data Archive for sharing of the dataset with the broader research community.
• Describe? the plan to incorporate data from NDI searches.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) 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.

The following modifications also apply:

• The National Library of Medicine has a website that lists NIH Data Sharing Repositories, where data dictionaries of shared studies can be reviewed for potential relevance. The NIMH-supported National Data Archive constitutes a searchable repository of subject-level data sets from NIMH-sponsored and other research, including data from prevention trials. The data in the NIMH Data Archive can be used without recontacting the PIs who deposited the data. However, there are likely relevant data sets that have not been deposited into either the NIMH Data Archive or the other NIH data repositories. The NIMH Data Archive also offers tools, such as Global Unique Identifiers (GUIDs) to address participant privacy and allow data to be anonymized and shared via the NIMH Data Archive Tools. NIMH understands that the information needed to generate a GUID may not be available for all data sources. Sharing of datasets for broad research use is strongly encouraged, when appropriate. Inter-university Consortium for Political and Social Research (ICPSR) also maintains a data archive of more than 250,000 files of research in the social and behavioral sciences and can potentially be used as a resource for finding relevant data. The Compendium of Federal Datasets Addressing Health Disparities is a compilation of information on health equity data.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

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 SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. 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

Part I. Overview Information 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 Policy on Late Application Submission.

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 SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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 fieldof 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 FOA 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 SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIMH, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Section V. Application Review Information

1. Criteria

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

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

Overall Impact

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 review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA:

• How likely is it that the results will advance understanding of whether prevention interventions delivered earlier in life have an impact on suicide risk and mortality outcomes? To what extent will the proposed research inform understanding of for whom (e.g., among underrepresented and typically understudied populations) and under what conditions (e.g., at what stage of development) early intervention confers protection?
• To what extent will the results advance understanding regarding key targets or change mechanisms that account for broad and sustained outcomes and moderators of response in a manner that can guide future efforts at intervention refinement and/or deployment.

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Specific to this FOA:

• To what extent does the study team include appropriate expertise relevant for: 1) integrating/harmonizing data sets, 2) applying state-of-the art statistical/computational approaches for analyzing integrated data sets, and 3) examining cross-over effects associated with suicide related thoughts, behaviors, risk and mortality?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA:

• To what extent does the proposed research utilize novel, transformative approaches that leverage and aggregate existing prevention datasets to advance our understanding of the long-term and cross-over effects of prevention interventions on suicide risk?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

• How well does the application describe and justify the operationalization of suicidal thoughts and behaviors, including how these key outcomes were assessed in the original prevention trials and plans for how these outcomes will be operationalized for the current analyses, including the approach to using data from the NDI?
• To what extent does the application address the strategy for identifying and selecting prevention trials for inclusion in the integrated data set?
• How well does that application detail and justify strategies that will be used to harmonize data across trials, including plans that will be used to integrate data from trials that used different measures to assess the same construct and/or to derive latent variables for key constructs of interest that were not directly assessed?
• How well does the application address plans to examine change mechanisms and mediators that might account for suicide risk outcomes and sustained effects?
• How well does the application detail the sample characteristics with regard to gender, race, ethnicity, and developmental stage and address plans for examining moderators of response, including differential impact of the intervention across subgroups, as appropriate?
• How well does the application provide detailed and convincing power analyses for key aims, including power for analyses that address cross-over- and long-term- outcomes, analyses to identify key change mechanisms (e.g., changes in targeted self-regulatory skills, family processes) or other mediators of effects, and analyses to identify moderators of response and/or explore subgroup analyses?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

• 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.

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 VI. Award Administration Information

1. Award Notices

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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. 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, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that 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 FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 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.”

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recpients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Performance and proper conduct of all research in accordance with the Terms and Conditions of Award.
• Accept close coordination, cooperation, and participation of NIH program staff in the scientific, technical, and administrative management of the grant.
• Overseeing the overall budget, activities and conduct of the research; this includes implementing the research protocol, obtaining IRB approval, obtaining prevention trial data sets, and establishing and implementing approaches for data integration and harmonization, quality control, data analysis and interpretation, and publication of results.
• Submit progress reports.
• Provide administrative leadership and coordination of all meetings with NIMH staff.
• Sharing data, resources and software according to the approved sharing policies for the NIH, including preparation of a final harmonized prevention trial dataset that will be deposited into the NIMH Data Archive (NDA).
• Define the details for the project within the guidelines of this FOA.
• Oversee and perform the scientific activities.
• Administratively manage the grant.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• The NIH will assign a Project Scientist as the point of contact to work with the PD(s)/PI(s) to ensure the objectives of the program are being met. - The Project Scientist(s) will interact scientifically with the PDs/PIs and other named personnel of the award, as a partner in the research, including providing technical assistance, advice, and coordination of depositing of the harmonized data. However, the role of NIH staff will be to facilitate and not to direct the activities.
• A Program Officer will be assigned to this award.
• The Program Officer will be responsible for normal scientific and programmatic stewardship and guidance for the overall project within the NIMH.
• The Program Officer will be responsible for milestone negotiations to ensure that the milestones are achieved and goals are being met.
• The Program Officer is responsible for monitoring the agreed data sharing plan and timeline.
• NIMH staff will interact with the PD(s)/PI(s) on a regular basis to monitor progress. Monitoring may include: regular communication with the PD(s)/PI(S) and his/her staff, periodic site visits for discussion with the recipients'’ research team, fiscal reviews, and other relevant stewardship activities.
• The NIH reserves the right to terminate or curtail the award (or an individual part of the award) in the event of inadequate progress or data reporting.
• NIMH staff will make recommendations for continued funding based on overall study progress, including meeting of planned milestones.

Areas of Joint Responsibility include:

• Ensuring that sites and investigators as well as NIH and other research partners fully comply with federal regulatory requirements. This includes, but is not limited to those relating to human subjects protections and informed consent.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: the PI, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

All costs requested and all changes in budgets after the first year should be clearly identified and justified.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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.

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. NIH FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Adam Haim, Ph.D.
National Institute of Mental Health (NIMH)
Email: Haima@mail.nih.gov

Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: nick.gaiano@nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@mail.nih.gov

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.