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 current second phase outlined in this NOFO and the companion NOFO (PAR-24-240 U01) aims to build on the prior success of APN-1 and further expand these efforts by targeting currently 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.

This specific NOFO will support a coordinating center that will enhance the current APN-1 collaborative structure, promote new and ongoing collaborative activities and data harmonization efforts for the APN-2.

Research Objectives

The APN-2 Coordinating Center (APN-2 CC) will:

1. Coordinate data harmonization and joint analyses across network projects:

• In coordination with the APN-2 Network Steering Committee (NSC) and the relevant Network Working Groups (see Organization and Management of the Ancestral Populations Network-2 (APN-2) section below) propose specific collaborative topics (e.g., phenotypic data harmonization, genomic data harmonization, incorporation of Social Determinants of Health (SDOH).
• Per the guidance of APN-2 NSC, coordinate and oversee the selected collaborative activities.
• Provide network wide guidance and best practices for each project to facilitate the network wide data harmonization effort.
• Develop necessary analytical pipelines needed for the data harmonization.
• Develop a network web resource that will serve the network members, and once complete, serve the entire scientific community.

2. Function as a liaison between the APN-2 network and appropriate NIMH data repositories (e.g., NIMH Data Archive (NDA), NIMH Repository and Genomic Resource (NRGR), or other NIMH designated repositories as applicable) to facilitate data and biospecimen deposition and sharing as required by NIH and NIMH data sharing policies (https://sharing.nih.gov/data-management-and-sharing-policy; https://grants.nih.gov/grants/guide/notice-files/NOT-MH-21-265.html; https://grants.nih.gov/grants/guide/notice-files/NOT-MH-23-100.html)

3. Plan, coordinate, and facilitate research training activities across the APN-2 network and develop best practices guidance for individual member projects.

• In coordination with the APN-2 Network Steering Committee and the relevant Network working groups, propose specific network-wide research development activities.
• Coordinate and lead selected research training activities for network members.
• Develop guidance and best practices for the individual member projects.
• Develop and disseminate ethical best practices for APN-2 network members and the scientific communities, with a specific focus on psychiatric genetic studies in different settings around the world.

4. Provide administrative support for the network workgroups and steering committee as needed.

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

The U24 award (PAR-24-241 and the U01 awards supported under the companion NOFO PAR-24-240 U01 will be governed by the Ancestral Populations Network Steering Committee (NSC). The role of the NSC will be (i) to make decisions related to network-wide activities based on majority votes, (ii) to facilitate between the different network projects and network working groups.

APN-2 Coordinating Center (APN-2 CC), funded via the current NOFO, 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. In addition, the APN-2 CC will be responsible for coordinating required U01 elements (such as career development and local community engagement) as well as overseeing network-wide meetings and calls. All the APN-2 CC functions will be done in full coordination with the APN-2 Network Steering Committee and will require their approval via a majority vote. 

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) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not 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 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:

Email: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 Budget

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

  Applications should include allocated funds for travel to 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:

Applicants are required to include the following information:

1. Coordinating Center (CC) overview and management:

• Provide an overview of the proposed CC and how it will be structured to achieve the center’s primary objectives (see above for the Research Objectives of the CC).
• Describe the components and management structure of the proposed CC, including key personnel and their responsibilities.
• Describe the proposed consortium management plan, including interactions with APN-2 projects, APN-2 Steering Committee and APN-2 Working Groups.
• Discuss prior experience in coordination of, and collaboration with, large global consortia focused on clinical and large-scale genetic research.
• Include a detailed proposed timeline and milestones for tracking all aspects of the center and the proposed activities, including quantitative metrics whenever feasible.

2. Plans and approaches for best practices, guidelines development and data harmonization:

• Describe plans for development of guidance and best practices for genotype and phenotype tasks, as well as ancillary efforts (social determinants of health, ethics, community engagement, etc. as specified in the U01 NOFO) in APN-2 projects.
• Describe plans for data integration and harmonization across APN-2 projects, data quality assessment and validation. Describe the planned analytical framework to achieve a common APN-2 network genomic and phenotypic data resource. Describe what privacy and security safeguards will be implemented when applicable. Further consideration should be given to harmonizing with prior generated APN-1 data.
• Provide plans for facilitating investigators’ submissions and dissemination of consortium data and metadata to NDA and NRGR or other designated NIMH repositories, as applicable,
• Describe plans for development of network wide research training activities and how these will serve the different network members in an equitable manner.

3. Plans and approaches to serve as an Administrative and Coordinating Center for the APN-2 Network:

• Describe strategies and approaches for enabling communication and coordination of APN-2 Network-wide activities between the different network projects, working groups, Steering Committee and NIMH Program staff.
• Describe plans to facilitate an annual APN-2 Network-wide meeting. Include descriptions of needed logistical and operational management.
• Describe how coordinated submission and publication of APN-2 Network wide joint manuscripts, conference symposia, posters and other types of relevant APN-2 wide activities will be supported.

Applicants must include an annual Milestones Section. Milestones should be well described, specific, measurable, and should include scientifically justified benchmarks. Milestones may include the following: harmonization of phenotypic and genotypic data collection by the U01s, coordination of network activities, coordination of data analysis, submit data and biospecimens to the appropriate, approved repositories, coordinate publications and annual meetings. 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 appropriate access to data and research outcomes, and shared benefits. Strong representation and leadership roles for investigators from all participating sites, with equal opportunities for providing input and decision making throughout the research project, should be demonstrated. If an application is a multiple PI (MPI) application, a detailed and justified leadership plan should be provided, outlining the specific roles of all individuals. A detailed conflict resolution section should 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. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded by NIMH under this NOFO are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-23-100). Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this NOFO are expected to use these technologies to submit data to NDA.

To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDA website provides two tools to help investigators develop appropriate strategies: 1) the NDA Data Submission Cost Model which offers a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent available from the NDA's Data Contribution page. Investigators are expected to certify the quality of all data generated by grants funded under this NOFO prior to submission to NDA and review their data for accuracy after submission. Submission of descriptive/raw data is expected semi-annually (every January 15 and July 15); submission of all other data is expected at the time of publication, or prior to the end of the grant, whichever occurs first (see NDA Sharing Regimen for more information); Investigators are expected to share results, positive and negative, specific to the cohorts and outcome measures studied.For more guidance on submitting data to NDA, refer to the NDA Data Management and Sharing Plan on the NDA website. NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary. 

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

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

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

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.

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.

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 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

Any instructions provided here are in addition to the instructions 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.

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

2. Review and Selection Process

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

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

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

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

• Provide scientific and administrative leadership and coordination of data harmonization, data pipelines, and other activities across the APN-2 network awards.
• Oversee and perform the scientific activities within the guidelines of this NOFO.
• Accept close coordination, cooperation, and participation of NIMH program staff in the scientific, technical, and administrative management of the grant.
• Provide periodic progress reports summarizing the APN-2 CC network activities, and achievement of project milestones to NIMH staff as requested.
• Serve as a voting member of the APN-2 Steering Committee (SC) and fulfill related duties outlined below in Areas of Joint Responsibility.
• Coordinate at least monthly network wide meetings and annual in person meetings. The PD/PIs will be responsible for preparing and disseminating concise proceedings or minutes to the SC members and for providing travel funds for themselves and their research team members to attend the annual in-person meeting.
• Adhere to NIMH policies regarding intellectual property and other policies that might be established during the course of this activity.
• Accept and implement the common guidelines and procedures approved by the Steering Committee and NIMH.
• 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 DHHS, 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 facilitate liaison activities for partnerships and provide assistance with access to NIH-supported resources and services.

The NIMH Project Scientist will be responsible for:

• Providing guidance and support in the design of research activities.
• Serving as a resource for protocol design and development.
• Advising in the selection of sources or resources.
• Advising in management and technical performance.
• Participating as a voting member in the APN-2 Network Steering Committee (NSC).

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 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 Network SC, 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-24-240) 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 Network Steering Committee will serve as the governing board for APN-2 U01 and U24 recipients . All participants in the APN-2 program are required to follow all the decisions approved by the Steering Committee; adoption of such decisions require a majority vote. Recipients under this NOFO will be required to accept and implement decisions approved by the NSC.

Membership in the NSC will include MPIs and representatives from each project participating site, per the project specific Leadership decision and with further consultation with the NIMH Project Scientist. The NIMH Project Scientist will be a voting member of the NSC. It is expected that most of the decisions on the activities of the Steering Group will be reached by consensus. If a vote is needed, each receipient will have one vote and the Project Scientist collectively will have one vote.The NIMH Project Scientist may not serve as the Chair or Lead of the NSC. The Program Officer will not have a vote.

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

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 Steering Committee 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.