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

Background:

Epidemiologic studies have shown that psychiatric disorders constitute a significant public health burden across diverse populations worldwide. These disorders are characterized by marked genetic heterogeneity, with both common and rare variation contributing to the complex phenotypic outcomes. For reasons such as population homogeneity and ease of ascertainment, most genome-wide genetic studies to date have mainly focused on cohorts of European ancestry. However, no single population is sufficient to fully uncover the variants underlying neuropsychiatric diseases in all populations. The absence of diverse ancestries in genomic studies has therefore negatively impacted their ability to illuminate the full genetic architecture of complex neuropsychiatric traits. Populations with different ancestral origins vary in terms of allele frequencies, biological adaptations, and other properties that affect the detectability and importance of risk variants. Lack of ancestrally diverse genome-wide data can lead to the misidentification of causal variants due to cryptic population stratification or simply overlooking a causal variant altogether, since rare variants are likely to be more recent in origin and more geographically localized. Furthermore, inclusion of global populations of non-European ancestry in genome-wide studies is necessary for comprehensive gene discovery efforts to identify true disease causal variants. Native populations of non-European origin will allow for fine-mapping of genetic loci through population differences in variant frequencies, as well as testing of both the effects of more recent rare alleles within those populations and whether ancient functional alleles that are not present in European populations confer risk of mental illness when coupled with these more recent alleles of severe effect (e.g., compound heterozygosity, digenic inheritance, or oligogenic inheritance). Inclusion of diverse representation of global ancestral populations in genetic studies will ultimately advance the goal of global mental health equity.

To address this gap, in 2019 NIMH released two Notices of Funding Opportunity (NOFOs; PAR-20-026 and PAR-20-027) which served as the basis for establishing the NIMH Ancestral Populations Network (APN-1, https://www.nimh.nih.gov/about/organization/dnbbs/genomics-research-branch/ancestral-populations-network-apn). The second phase outlined in this NOFO and the companion NOFO PAR-24-241(U24) aims to build on the prior success of APN-1 and expands these efforts by targeting unexplored gap areas. The next phase of the APN will prioritize diversifying the geographic, clinical, and genomic representation of NIMH supported studies to further increase our understanding of the genetic architecture of mental illnesses and enhance the value and utility of the scientific resources to be generated for the field. 

 Research Objectives:

This NOFO seeks applications proposing coordinated efforts to accelerate gene discovery for psychiatric disorders in cohorts of non-European ancestry to ultimately advance the goal of global mental health equity (the principle underlying the continual process of ensuring that all individuals or populations have optimal opportunities to attain the best health possible). Projects should apply cutting-edge genome-wide approaches and incorporate clinical assessments, including structured clinical interviews (e.g., Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders [DSM] [SCID], Diagnostic Interview for Genetics Studies [DIGS], Family Interview for Genetic Studies [FIGS]), and other phenotypic instruments as appropriate. Recruitment of new subjects or re-contact of existing subjects for the purpose of collecting new biospecimens or obtaining more complete clinical data is permitted. Projects are also encouraged to leverage existing data resources (e.g., medical records, genetic data, or phenotypic data). Projects are encouraged to coordinate with other ongoing NIH and NIMH consortia efforts in psychiatry and genetics worldwide and to leverage existing infrastructure and collaborative networks where research-grade psychiatric diagnostic assessments are performed and are primed to conduct genomic analysis in ancestral populations (e.g., APN-1). 

Specifically, the next phase of the Ancestral Populations Network (APN-2) seeks to expand the previous APN-1 phase scientific accomplishments, by supporting studies that (i) aim to further enhance and broaden previous supported genomic and phenotypic characterization of non-European ancestry populations worldwide (including both US and non-US based), (ii) propose studies that aim to diversify previously supported NIMH genomics discovery efforts, by targeting new, non-European populations, with broader inclusion of psychiatric disorders and phenotypes of relevance to serious mental illnesses, and/or (iii) propose novel genome-wide characterization by technologies or analytical pipelines not used previously in APN-1.

Projects should form research teams that demonstrate strong representation and leadership roles for investigators from all participating sites, with substantial opportunities for providing input and decision making throughout the research project.Broad sharing of biomaterials, genetic data, and phenotypic data with the NIMH Repository and Genomics Resource (NRGR), NIMH Data Archive (NDA) and other NIH databases, for use by the global scientific community is expected for all projects supported through this initiative as permitted by national and local policies and regulations (NIH Data Management and Sharing Policy DMSP policy, and NRGR Biospecimen notice (NOT-MH-21-265)).

As part of this initiative, all applications must include career development and local community engagement elements as integral components of their study design. Research infrastructure elements are encouraged but not required.

• Career Development Element (required): Studies must take into consideration the career development needs of their project members, including but not limited to the needs of early career project members from low resource settings ( Low and Middle Income Countries (LMICs) as defined by the World Bank: https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-) and/or individuals from  groups underrepresented in the biomedical research workforce (see, e.g., Notice of NIH's Interest in Diversity, NOT-OD-20-031 ) to foster an inclusive research training environment for all program participants. All proposed activities should be in scope of the project scientific aims. These can include, but are not limited to, (i) training opportunities as part of the ongoing study activities (e.g., project relevant clinical or genetic analysis training); (ii) sponsorship of attendance in relevant project focus courses, external trainings, or scientific meetings; (iii) career advancement mentorship (e.g., scientific paper writing, grant writing).
• Infrastructure Development Element (encouraged): In addition, studies are encouraged (but not required) to propose activities to enhance local scientific research infrastructure, with an emphasis on low resource settings (Low and Middle Income Countries (LMICs) as defined by the World Bank: https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups) and keeping in scope with the project scientific aims. This can include but is not limited to, set-up of new/upgraded relevant equipment, supplies and relevant analytical cores, including training of relevant core staff; creation of local biospecimen repositories including required training for relevant staff while adhering to NIH/NIMH data sharing requirements (such as NIMH data sharing policy and NIMH biospecimen sharing policy). If studies, choose to add such activities a strong rationale for the specific selections should be provided including details on how these activities will benefit the specific project scientific aims.
• Local Community Engagement in planned research Element: Applicants should include a comprehensive community engagement plan as appropriate for the proposed study design and specific study performance site(s). Studies are strongly encouraged to engage local community representatives throughout the project, from study design to engagement in project specific awareness, recruitment, and dissemination of results. Collaboration with a diverse set of local stakeholders is recommended. This may include, but is not limited to, health and development agencies, local government agencies, non-profit organizations, advocacy groups, families and individuals with relevant lived experiences. A plan to evaluate the effectiveness of the proposed engagement activities and contributions should be included and a process for optimizing procedures should be described.

Organization and Management of the Ancestral Populations Network-2 (APN-2):

All awards supported under this NOFO and the companion NOFO (PAR-24-241 (U24) will be governed by the (APN-2 Network Steering Committee [NSC]). The role of the NSC will be (i) to make decisions related to network-wide activities based on majority vote and (ii) to facilitate between the different network projects and network working groups.

APN Coordinating Center (APN CC), funded via the companion NOFOPAR-24-241 (U24), will be responsible for developing and implementing best practices for data integration and harmonization across network projects, to enhance rigor and reproducibility and generate a resource for network members and the scientific community. The APN-2 CC functions will be done in full coordination with the APN NSC and will require their approval via a majority vote.

Protection of Human Subjects: Applications with data collection plans that involve multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, and administrators) should address provisions for human subjects protections and consenting procedures for all participant groups accordingly. The NIMH published updated policies and guidance for investigators regarding human research protections 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 must 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.

Applications considered NOT responsive to this NOFO are those:

• That do not include both career development and community engagement elements.
• Proposing to develop, test or validate clinical interventions.
• That propose research using animal models.

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 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 individuals from 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 How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement 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 How to Apply - 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:

nimhpeerreview@mail.nih.gov

Page Limitations

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

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

Applications should allocate funds for APN-2 Network collaborative activities. These include but are not limited to: (i) common collection and analysis of specific data measures across all APN-2 network projects; (ii) coordination with the network coordinating center (APN-2 CC) for data harmonization efforts (this includes common and individual measures each project will collect); (iii) travel to an annual APN-2 network meeting for key study personnel, and potentially to additional network-specific meetings as applicable. 

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy:

Applicants are required to submit research projects that will accelerate gene discovery for psychiatric disorders using population cohorts of non-European ancestries. Applicants must:  

• Describe unique features in the proposed population that will contribute to accelerating gene discovery for psychiatric disorders across ancestrally diverse global populations.
• Describe the plans for assessing genome-wide contributions of disease risk using cutting-edge technologies and approaches. Please review the recommendations of the National Advisory Mental Health Workgroup on Genomics, which were approved by the National Advisory Mental Health Council.
• Describe the rationale, strategies, and methodologies for collecting and analyzing the genomic data that will be utilized in the proposed analyses.
• Describe innovative strategies that will be utilized for the analysis of ancestrally diverse data and how admixture in the study populations will be addressed.
• Describe how the proposed analyses and methods will support the identification of a full spectrum of ancestry-specific genomic associations for psychiatric disorders.
• Describe how individual ancestry of study participants will be determined and what measures will be implemented to account for potential ancestry- driven confounding effects in the analyses.
• Describe how the planned analyses will provide insight into ancestry-specific genetic risk architecture and shared genetic risk across global populations.
• Describe plans for generating new genomic data (e.g., whole genome sequencing). If generating data from existing samples, describe plans to ensure the DNA samples are of sufficiently high quality to anticipate high-quality sequencing results.
• If existing genomic data will be leveraged, describe how it will be harmonized across contributing sites or studies for the analysis.
• Describe the rationale, strategies, and methodologies for collecting the clinical/phenotypic data that will be utilized in the proposed analyses.
• Describe the data that will be utilized, such as structured interviews (e.g., Structured Clinical Interview for DSM [SCID], Diagnostic Interview for Genetics Studies [DIGS], Family Interview for Genetic Studies [FIGS]), and/or other phenotypic data such as dimensional measures (e.g., as represented in PhenX Toolkit, NIH Toolbox, RDoC).
• If existing clinical/phenotypic data will be leveraged, describe how they will be harmonized across contributing sites or studies for the analysis.
• Applicants, where applicable, are required to collect and incorporate in their study design Social Determinants of Health (SDOH) measures (https://health.gov/healthypeople/priority-areas/social-determinants-health), as appropriate for the target populations, study settings and environments. Applicants should provide a strong rationale for the selection of the specific SDOH measures to be collected and provide a detailed plan on how these will be incorporated in the study design, with further information on how these will inform study results and reduce potential biases.

Additional Application Elements:

Career Development and Infrastructure Development Elements: 

Applicants must provide a detailed description of the following as applicable to their study design and specific performance site(s):

• The selected activities and strong rationale for the specific selection, including details on how these activities are in scope of the project scientific aims and will benefit specific project members.These activities can include but are not limited to: (i) training opportunities as part of the ongoing study activities (e.g., project relevant clinical or genetic analysis training); (ii) sponsorship of attendance in relevant project focus courses, external training, or scientific meetings; (iii) career advancement mentorship (e.g., scientific paper writing, grant writing).
• Experience and expertise of any mentor team proposed to successfully conduct the proposed activities.
• Details about allocated resources and environment that will support the success of the proposed activities.
• Explanation on how the proposed activities will enhance individual or group abilities to successfully participate in (a) the current project, (b) similar research projects, and/or (c) to contribute to their career growth in psychiatric genetics.

Local Community engagement element:

 Applicants must include a comprehensive community engagement plan as appropriate for the proposed study design and specific study performance site(s). Details should be provided on:

• The rationale for the specific selected community engagement strategies.
• Selection of specific stakeholders on the study community groups/advisory boards, how appropriate and representative are they to the specific study and the specific site environment.
• The specific activities and budget resources that the selected local community group will oversee and/or be engaged in as part of recruitment and/or research training applicable to the study. 
• A plan to evaluate the effectiveness of the proposed engagement activities and contributions should be included and a process for optimizing procedures should be described.

Applicants must also include an annual Milestones Section. Milestones should be well described, specific, measurable, and should include scientifically justified benchmarks. Milestones may include the following: generation of genomic datasets for identification of the full spectrum of genetic variation associated with the disease; computational analysis; validation and quantification of such variation. The milestones should be regarded as criteria for evaluating the progress and direction of the Research Project and should not be just a restatement of the specific aims. Achievement of milestones will be evaluated by NIMH, and funding of non-competing award years will depend on milestone accomplishment.

Multiple PD/PI Leadership Plan

When designing the study team, strong consideration should be given to equitable collaborative team formation and leadership opportunities for all participating researchers from all participating sites (as defined in section I of this NOFO). If an application is a multiple principal investigator (MPI) application, a detailed and justified leadership plan should be provided, outlining the specific roles of all individuals. A detailed conflict of resolution section must be included, following NIH guidelines for MPI leadership plans.

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. Applicants should refer to the  NIH Data Management and Sharing (DMS) policy and NIMH NOT-MH-23-100 for additional information. 
• All applications, regardless of the amount of direct costs requested for any one year, must include a Data Management and Sharing Plan. All projects will be expected to incorporate broad data and sample sharing as permitted by national and local policies and regulations to generate a resource for promoting global gene discovery efforts. Sharing will be expected to occur in a timely manner likely to provide maximal scientific value for expanding understanding of genetic based ancestral differences
• Plans should include sharing clinical and genotypic data and bio-samples with the NIMH Repository and Genomics Resource (NRGR https://www.nimhgenetics.org/), and NIMH Data Archives (NDA, https://nda.nih.gov/), as appropriate.
• The NIH Genomic Data Sharing Policy (NOT-OD-14-124) will apply to any large scale human or non-human genomic data generated under this project, as well as the use of these data for subsequent research (https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing/).

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.

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.

7. Other Submission Requirements and Information

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 for responsiveness by the National Institute of Mental Health, NIH. Applications that are incomplete, non-compliant, and/or nonresponsive will not be reviewed.  

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

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

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

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov. 

Post Submission Materials

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.

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).

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.

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. 

Specific to this NOFO:

Career development and research infrastructure elements: 

• How appropriate are the selected activities and are they sufficiently described?
•  How well do the proposed activities align with the project scientific focus and aims?
• As applicable, how suitable is the proposed mentor team to successfully achieve the proposed activities?
• As applicable, how adequate are the proposed resources and environment?
• How will the proposed activities enhance individual or group abilities to successfully participate in (a) the current project, (b) similar research projects, and/or (c) to contribute to their career growth in psychiatric genetics?

 Local Community engagement component:

• How appropriate is the proposed community engagement plan and proposed activities for the specific study and proposed setting(s)?
• To what extent is the composition of the proposed community group(s)/advisory board(s) for the study design appropriate, and to what extent does it reflect an understanding of the local communities or populations to be engaged in the study?
• How appropriate is the evaluation plan for the effectiveness of community engagement activities?
• To what extent did the applicants provide sufficient, convincing information about their strategies to optimize the community engagement activities  as needed based on their proposed evaluation plan? Examples of community engagement activities include collaboration with local community representatives for study design, recruitment, and dissemination of results.

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIMH in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. 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.

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

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. 

.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 (HHS) grant administration regulations at 2 CFR Part 200, 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 recipients 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 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• Define objectives, approaches, and to plan and conduct the proposed research and assume responsibility and accountability to the applicant organization and to the NIMH for performance and proper conduct of all research supported in this initiative, in accordance with the Terms and Conditions of Award.
• Provide interim progress updates when requested by NIMH or at a frequency determined by NIMH.
• Provide leadership in thoughts, ideas, and actions, working with the Steering Committee for the cooperative agreement.
• Coordinate and attend at least monthly Steering Committee meetings. The PD/PIs will be responsible for preparing concise proceedings or minutes (two or three pages), which will be delivered to all members within one week of the meeting.
• Attend and participate in in-person meetings amongst the PIs awarded under this initiative and the companion NOFO (U24), with the frequency determined by the Steering Committee.
• Accept close interaction with, and participation of, a NIMH Project Scientist in the APN-2 Network Steering Committee (Network SC) to facilitate coordination among the grantees and other projects with related goals.
• Communicate and publish major findings in a timely manner. Publication or oral presentation of work done under this agreement will be accompanied by an appropriate acknowledgment of NIMH support, including the assigned cooperative agreement award number.
• Share data and resources generated under this project with the scientific community, as permitted by law, in a timely manner and as directed under the applicable NIMH and NIH policies sharing policies.

PD(s)/PI(s) agree to participate in the cooperative research program, including serving on the Steering Committee, participating in Steering Committee in person and virtual meetings, adhering to Steering Committee policies and decisions, and accepting the participation and assistance of NIMH staff in accordance with the guidelines described under Cooperative Agreement Terms and Conditions of Award: NIH Responsibilities.

All clinical research performed outside of the U.S. must, in addition to U.S. Federal regulations, comply with the host country regulations for protection of human subjects and conduct of clinical research.

The PD(s)/PI(s) will ensure that on-site administrative structure, scientific capacity, and training are available to enable the research team, including local research investigators and partners, to perform the research activities proposed in this grant.

Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

The role of the NIMH Project Scientist will be to facilitate and not to direct the activities. It is anticipated that the NIMH Project Scientist will offer advisory input. The NIMH Project Scientist will:

• Provide guidance and support in the design of research activities.
• Serve as a resource for protocol design and development.
• Advise in the selection of sources or resources.
• Advise in management and technical performance.
• Participate as a voting member in the APN-2 Network Steering Committee (NSC). Regardless of the number of Project Scientists, NIH will only have one vote.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The NIMH Program Official will:

• Be responsible for the normal scientific and programmatic stewardship of the award, including programmatic monitoring of the overall project.
• Be responsible for negotiating and monitoring the implementation of data and research resource sharing plans and the milestones to ensure that the goals of the project are being met.
• Approve modifications to the research plan and/or study protocol(s), in consultation with the NSC, based on emerging data and/or other issues that impact progress of the project.
• Reserve the right to obtain periodic external peer review and recommend reviewers for an assessment of progress and achievement of milestones and deliverables.
• Monitor performance and compliance with NIH procedures.
• Participate in the APN-2 Network Steering Committee (NSC), NSC working group and/or special committee meetings and conference calls as a non-voting member and serve as an administrative liaison.

Areas of Joint Responsibility 

• Coordination and facilitation of interactions among the recipients under this initiative.
• Facilitation of collaboration with other NIMH-supported research resources.
• Assist in avoiding unwarranted duplication of effort with other NIH efforts.
• Schedule and organize an in-person meeting to be held in conjunction with all projects awarded under this NOFO and the companion NOFO (PAR-24-241) for the purpose of dissemination of ideas and encouragement of scientific collaboration. The frequency of these meetings (annual, semi-annual, etc.) will be determined by the Steering Committee, who will be responsible for scheduling the time and place and for preparing concise proceedings or minutes (action items and one-two page summary) which will be delivered to the members of the Committee within 2 weeks of the meeting.

APN-2 NSC will serve as the governing board for APN-2 recipients. All participants in the APN-2 program are required to follow all policies and procedures approved by the NSC; adoption of such policies and procedures requires a majority vote. Recipients under this NOFO will be required to accept and implement policies approved by the Steering Committee.

Membership in the NSC will include MPIs and representatives from each project participating site, per project specific leadership decisions and with further consultation with the NIMH Program Scientist for the project. It is expected that most of the decisions on the activities of the Steering Committee will be reached by consensus. If a vote is needed, each recipient will have one vote and the NIMH Project Scientist(s) collectively will have one vote. The NIMH Project Scientist may not serve as the Chair or Lead of the NSC. The Program Official will not have a vote.

The APN-2 NSC leadership will be chosen by a majority vote of the NSC. The Network leads will be responsible for chairing meetings and facilitating discussions during network meetings.

The APN-2 CC in coordination with NIMH will be responsible for coordinating Network related teleconference calls and logistical planning for the APN annual in person meeting.

The APN-2 Network wide calls and annual meeting will be forums for members to provide the latest updates on their research, exchange ideas and information, and discuss collaborations among members of the APN. Meeting participants will identify the group’s tangible resources, capabilities, and needs to advance the APN's overall goals. The PD(s)/PI(s) of each APN (or a designated representative) is required to make an oral presentation on current, planned activities, and projects at each annual meeting, as well as  periodically provide updates on project progress during the APN network wide calls. 

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the NSC chosen without NIH staff voting, 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 recipient. 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 HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

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: GrantsInfo@nih.gov (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: support@grants.gov

Miri Gitik, Ph.D. 
National Institute of Mental Health (NIMH)
Telephone: 301-827-3523
Email:  miri.gitik@nih.gov

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

Heather Weiss
National Institute of Mental Health (NIMH)
Telephone: 301-443-4415
Email: Weissh@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 2 CFR Part 200.