Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

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

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

This Notice of Funding Opportunity (NOFO) invites applications for a Data Coordinating Center (DCC) to support the work of the research projects funded under the Individually Measured Phenotypes to Advance Computational Translation in Mental Health (IMPACT-MH) initiative described in the companion announcement RFA-MH-23-105. The IMPACT-MH initiative has an overall goal of using behavioral measures and computational methods to identify novel clinical signatures that could be used to guide clinical decision-making. The IMPACT-MH DCC funded under this NOFO will: (a) facilitate regular communication and coordination among the funded IMPACT-MH projects; (b) where applicable, support the use of common data elements, standard measures, and uniform data collection procedures; (c) build informatics infrastructure and pipelines necessary to gather and store de-identified, participant-level data; (d) perform computational analyses on datasets collected across all project sites; (e) monitor collected data to identify and address potential biases in data collection, analysis techniques, or subject recruitment and retention practices. The DCC will also maintain a list of the measures and tools used across the funded IMPACT-MH projects, as well as best practices of data collection and analysis, in order to inform future additional studies or future stages of the IMPACT-MH initiative.

Background

Current approaches for diagnosing mental disorders lead to a great deal of heterogeneity within diagnostic groups and do not provide a sufficiently precise characterization of individual patients to maximally inform clinical decision-making. Using machine learning and other data-driven approaches to integrate data from behavioral assessment(s) with clinically available data has the potential to generate more precise and objective clinical phenotypes. These phenotypes, derived from individual participant-level measurements, could foster more informative classification schemes, improve clinical practice, and lead to the identification of specific pathology-related mechanisms.

Consistent with the Research Domain Criteria framework, the companion NOFO RFA-MH-23-105 seeks to support multiple studies that will enable data-driven algorithms to generate clinical phenotypes that can optimize evaluation at the level of the individual and which are informative for clinical purposes (e.g., predicting prognosis, enhancing clinical monitoring, and selecting effective treatments and doses). To maximize potential clinical utility and accessibility, the companion IMPACT-MH NOFO encourages applications that focus on the use of behavioral tasks and measures, such as computerized tasks administered via web- or device-based platforms and/or passive collection of behavioral data via mobile devices. Behavioral tasks are to be optimized to yield data amenable to computational analyses, including artificial intelligence, machine learning, or Bayesian techniques. Other measures will include data available via clinical records (such as diagnostic codes, demographic data, treatment history, clinician notes, and symptom rating instruments). Biological data, such as EEG, MRI, blood-based measures, or genomics, may be used judiciously to further refine or disambiguate novel clinical phenotypes. To ensure the longevity and usability of the data included in these research projects, the DCC will partner with the IMPACT-MH grantees to foster data collection and maintenance practices that allow for broad re-use and re-analysis of data as computational methods evolve.

Research Objectives

The IMPACT-MH DCC is expected to collaborate with the recipients awarded under the companion IMPACT-MH NOFO (RFA-MH-23-105) on activities supporting the identification of behavioral measures that provide added value to clinical records data to refine clinical decision-making. The DCC will work closely with IMPACT-MH projects to optimize harmonization, combine and store data from all IMPACT-MH projects, and monitor data to identify and address potential biases. The data analyses specific to the awards funded under the companion IMPACT-MH NOFO will be the responsibility of the IMPACT-MH grantees; however, the DCC can provide support and guidance to IMPACT-MH recipients as needed, and the DCC will conduct analyses of aggregated data sets, as appropriate.

The IMPACT-MH DCC funded under this NOFO will:

1. Facilitate coordination and communication across IMPACT-MH projects. The principal goal of the IMPACT-MH DCC is to support the efforts to identify novel clinical signatures that could be used to guide clinical decisions proposed by the IMPACT-MH projects funded under the companion NOFO (RFA-MH-23-105). The DCC will serve as a clearinghouse of novel behavioral measures, clinical assessment procedures, informatics approaches, quality improvement strategies, and research ideas proposed by IMPACT-MH projects. The DCC will (i) identify common and unique data collection, processing, and analysis methods employed across projects; (ii) facilitate partnerships among IMPACT-MH projects to use standard measures, common data elements, and integrated datasets for quality assessment and research purposes; (iii) promote fidelity monitoring and performance improvement activities across IMPACT-MH projects; and (iv) disseminate data-driven best practices for behavioral measurement, clinical assessment, and computational evaluation throughout the IMPACT-MH network. Applications are expected to describe how the DCC will collect and store pertinent information from each IMPACT-MH project. This information includes, but is not limited to, the aims and activities of individual projects, study protocols (including details of data collection methods and measurement parameters), data processing pipelines, and analysis tools.

The IMPACT-MH DCC will support this coordination by establishing a Steering Committee to oversee collaboration efforts among the IMPACT-MH projects. The Steering Committee should include Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) from each IMPACT-MH project and any additional liaisons identified by the PI(s)/PD(s), and additional members with expertise in the overall goals of the IMPACT-MH initiative. Experts in learning health care, measurement-based treatment, health information technology, health informatics, computational modeling, and other areas may be included, as appropriate. Applicants should not, however, contact potential Steering Committee members prior to the review of the application, nor should potential Steering Committee members be named in the application to avoid conflict of interest in the review process. The DCC will be responsible for organizing, providing logistical support, and running IMPACT-MH Steering Committee meetings. These responsibilities include organizing an initial kick-off meeting within the first 6 months of the DCC award. The purpose of this meeting will be to introduce project teams; identify areas of joint scientific interest; and establish processes and timelines for harmonization efforts (described below), data curation, and data submission. Additionally, the DCC will convene an annual all-hands meeting to highlight progress, challenges, and potential adjustments for improved coordination. The DCC will be responsible for ongoing communication with the IMPACT-MH Steering Committee through regular calls to be held at least quarterly. Costs associated with annual meetings and intervening teleconferences should be factored into the DCC budget.

2. Optimize harmonization efforts across IMPACT-MH projects. To maximize the long-term benefit of data acquisition and analysis, NIMH expects harmonization efforts that will permit data aggregation across IMPACT-MH projects that have shared scientific goals and measures. The DCC will play a primary role in supporting cross-project harmonization via the use of common data elements, standard measures, and uniform data collection procedures, to the extent possible. The scope and focus of IMPACT-MH projects may differ along multiple dimensions including the area of psychopathology (e.g., mood/anxiety disorders, disorders of behavior regulation, psychosis), the participant cohorts to be studied, and the specific assessments proposed. Projects may also differ in the extent to which existing data are employed to address scientific goals. Despite these potential differences, areas amenable to standard measurement are expected among IMPACT-MH projects. In cases where project teams propose to measure the same information (e.g., the same cognitive construct, symptoms, or the same demographic information), they will be asked to use identical measurement tools and collection procedures whenever feasible and should otherwise establish a means to aggregate across similar measures. IMPACT-MH DCC applicants must propose a process for (i) curating behavioral measures and common data elements planned for use by IMPACT-MH projects; and (ii) identifying opportunities for harmonizing behavioral measures, data elements, and assessment methods to increase concordance among IMPACT-MH projects. In addition, outline a consensus process directed at maximizing the clinical and scientific value of common and divergent assessments used in IMPACT-MH projects.

The DCC will play an integral role in supporting the harmonization efforts across the IMPACT-MH projects and must be prepared to collect and disseminate a guideline for best practices on administration and collection parameters for the data types used throughout the IMPACT-MH projects. Additionally, the DCC is expected to maintain a set of best practices and guidelines for the use of computational models and algorithms that will be implemented when identifying and validating clinical phenotypes. Applications must describe the DCC team’s ability to evaluate computational methods and provide assistance in maintaining best practices across all projects.

3. Develop and maintain a robust informatics infrastructure. The DCC will be responsible for building and maintaining an informatics infrastructure along with pipelines to gather and store de-identified subject-level data. The purpose of these tools is to support computational analyses on datasets collected across all IMPACT-MH projects. The data center will make the data Findable, Accessible, Interoperable, and Reusable (FAIR) to enable primary and secondary analyses. As part of the data infrastructure, the DCC will create validation tools to ensure that data submitted by the IMPACT-MH projects are consistent with the allowable values in the measures used. While each IMPACT-MH project will be required to have a data manager who will perform validation and quality assurances on each project's data, the DCC is expected to verify the integrity of individual data and monitor the completeness of any combined data sets that are generated.

The DCC will have responsibility for uploading subject-level data aggregated from the IMPACT-MH projects to the NIMH Data Archive (NDA). All data will be deposited into the NDA and made available to qualified investigators with approved NDA data access agreements according to the NDA data sharing regimen. The IMPACT-MH projects will use the NIMH Globally Unique Identifier (GUID) infrastructure to create de-identified subject codes. The GUID number represents a unique identifier that protects the anonymity of individual-level subject data. Staff at the NIMH Data Archive will be responsible for exporting the GUID infrastructure to all project teams. The DCC will maintain privacy procedures and security processes for safely receiving and storing de-identified data from each of the project teams.

4. Perform computational analyses on aggregated datasets. The DCC will also be responsible for analyses on the aggregated data from IMPACT-MH projects. While it will be difficult for DCC applicants to propose specific analysis plans before knowing the available data and protocols for the IMPACT-MH projects, DCC applications are expected to describe general approaches to test and optimize different computational models or algorithms. If the DCC team has prior experience deriving or validating clinical phenotypes, the relevant methodologies must be described in the application. Applications should also include plans to take models used successfully on data from one IMPACT-MH project and apply them to data from another project, where applicable. After the IMPACT-MH DCC and projects have been funded, the DCC will begin ongoing collaborations with NIMH program staff to determine potential analyses based on the funded projects. Each project funded under the companion announcement will propose, and be responsible for, its own scientific project and data analysis. The DCC will offer technical assistance to project teams when needed, specifically concerning the optimization of local computational methods to identify or validate clinical phenotypes.

5. Monitor and address potential biases in collected data and analytic approaches. The IMPACT-MH initiative recognizes the promise of data-driven approaches and computational modeling to support precision mental health, particularly as machine learning and artificial intelligence methods offer novel ways to identify patterns in large-scale, multimodal datasets. The initiative equally recognizes that computational approaches can introduce or exacerbate biases, which have the potential to occur at multiple stages of a research study. As a critical extension of its role in data and informatics management, the DCC is expected to carry out regular data evaluations, in partnership with awarded IMPACT-MH projects, to identify and address potential biases. The NIH Office of Data Science Strategy (ODSS) offers guidelines for researchers employing data-driven technologies. Specifically, they advise that researchers employing these technologies must take steps to minimize the harms that could result from their research, including but not limited to addressing (1) biases in datasets, algorithms, and applications; (2) issues related to identifiability and privacy; (3) impacts on disadvantaged or marginalized groups; (4) health disparities; and (5) unintended, adverse social, individual, and community consequences of research. Sources of bias in the data include, but are not limited to measurement tools and processes, subject recruitment and retention practices, handling of missing data, and computational algorithms. IMPACT-MH awardees will be responsible for primary evaluations of project data, and the DCC will be responsible for oversight of the data aggregated across projects. In this capacity, the DCC will be expected to monitor for assumptions and practices that introduce unintended bias and should develop strategies for countering these biases. Applications are expected to propose a process to assess aggregated data and provide resources to individual project teams to ensure that biases are detected and mitigated.

Research Team Expertise

The PD/PI (or Multi-PDs/PIs) of the DCC must be experienced in the coordination and management of multi-site clinical research studies, including success in meeting milestones and timelines. Additional expertise on the DCC team should include proficiency with multimodal data, and state of the art computational and data analytic skills.

Enhancing Diverse Perspectives

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.

NIH recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust. See Notice of NIH's Interest in Diversity (NOT-OD-20-031).

To support the best science, NIH encourages inclusivity in research. Examples of structures that promote diverse perspectives include, but are not limited to:

• Transdisciplinary research projects and collaborations among investigators from different fields.
• Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Individual applications and partnerships that enhance geographic and regional heterogeneity.
• Investigators and teams composed of researchers at different career stages.
• Participation of individuals from diverse backgrounds, including groups historically underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.

Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

Applications Not Responsive to this NOFO

Applications proposing the following will be considered non-responsive to this NOFO and will not be reviewed:

• Applications that do not include a plan to ensure that datasets adhere to FAIR data principles
• Applications that do not provide a detailed description of experience and expertise in data infrastructure management and computational methods
• Applications that do not include strategies to monitor and address potential biases in aggregated data and analytic approaches
• Applications that lack a Plan for Enhancing Diverse Perspectives

Technical Assistance. Applicants are strongly encouraged to consult with NIMH program staff when developing plans for an application (see Agency Contacts, Section VII).

In addition to any individual consultation with program staff, a web-based Technical Assistance Meeting will be held for potential applicants to this NOFO and companion NOFO RFA-MH-23-105 on Tuesday, May 2, 2023 from 2:00 pm - 3:00 pm ET, when NIMH staff will be available to answer general questions related to these funding announcements. Prospective applicants can participate in the meeting by joining Zoom Meeting ID: 161 090 9065 and are encouraged to submit their questions or comments in advance to RDoCAdmin@mail.nih.gov. Participation in the teleconference is neither required nor necessary for a successful application. A recording of the teleconference will be available at https://www.nimh.nih.gov/research/research-funded-by-nimh/rdoc/resources/rdoc-resources-webinar-series

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 Institutions) 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 not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov 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 SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this 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 SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Email: nimhpeerreview@mail.nih.gov

Page Limitations

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

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

• In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:
• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp.

SF424(R&R) Senior/Key Person Profile

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

In the biosketches, highlight the experience of each PD/PI (or Multi-PDs/PIs) of the DCC and all key personnel in the coordination and management of multi-site clinical research studies, including success in meeting milestones and timelines.

R&R Budget

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

Budgets should include all potential necessary staff. It is acceptable to include in the budget allocations for staff/personnel who are not yet named but whom the DCC will recruit once the IMPACT-MH projects have been funded and necessary areas of expertise have been fully identified.

Costs associated with virtual annual meetings and intervening teleconferences should be factored into the IMPACT-MH DCC budget.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: All of the following are required:

Significance:

Describe the scientific benefit to be gained from the application of computational methods to aggregated datasets that include behavioral measures of individual differences and data from the clinical record.

Explain why the proposed coordination across IMPACT-MH projects, harmonization of methods and measures, analysis of aggregated data, and development of a data infrastructure are optimal to achieve the scientific objectives of the IMPACT-MH initiative.

Investigators:

Highlight the multi-disciplinary experience of the team members in the following areas:

• large-scale multi-site studies, including computational approaches to the analysis of multivariate data and ethical considerations associated with large-scale analysis
• understanding of the characteristics and criteria needed for the application of computational algorithms to inform clinical decisions, with attention to mitigating potential biases
• data science best practices to ensure that data are amenable to future computational techniques

Innovation:

Describe the novel organizational concepts and management strategies the DCC will use in coordinating the IMPACT-MH projects.

Describe plans to employ unique or novel methodologies to combine data across IMPACT-MH projects, including methods such as data imputation to handle data that are related but not fully harmonized.

Approach:

Describe an overall strategy, operational plan, and organizational structure that is well-reasoned and appropriate to accomplish the goals of the DCC. Include strategies to ensure a robust and unbiased scientific approach across the U01 projects funded under the companion NOFO, identify opportunities for harmonization of methods and measures, and include discussion of potential problems, alternative strategies, and benchmarks for success. Provide a comprehensive description to establish feasibility and include an appropriate plan for workflow and project milestones.

Facilitate coordination and communication across IMPACT-MH projects

• Describe how the DCC will coordinate with IMPACT-MH projects funded under companion NOFO (RFA-MH-23-105) to support and enhance the efforts to identify novel clinical signatures that could be used to guide clinical decisions.
• Describe how the DCC will establish, organize, and provide logistical support for an IMPACT-MH Steering Committee. Include information about how often the Steering Committee will meet and the specific activities it will perform.

Optimize harmonization efforts across IMPACT-MH projects

• Describe the coordination with the leadership of the IMPACT-MH projects to develop a procedure for sharing information about study protocols and measures, optimization of local algorithms, selecting and prioritizing centralized analyses to be performed, and planning for publications.
• Outline a consensus process directed at maximizing the clinical, administrative, and scientific value of common and divergent ascertainment and assessment practices used in the IMPACT-MH projects
• Describe potential challenges to standardized data collection and propose strategies to address those challenges.

Develop and maintain a robust informatics infrastructure

• Propose a data management system that includes the data infrastructure and pipelines necessary to gather, combine, store, and manipulate de-identified multi-modal data from multiple IMPACT-MH projects in a timely manner.
• Provide a detailed plan for receiving subject-level data from the IMPACT-MH projects and uploading the data into the NDA on expected intervals.

Perform computational analyses on aggregated datasets

• Outline plans to collaborate with the Steering Committee and NIMH program staff to conduct analyses on the aggregated data from IMPACT-MH projects. If the DCC team has prior experience deriving or validating clinical phenotypes, this should be described in the application.
• Include a description of the DCC team’s ability to evaluate and optimize computational methods that might be used with harmonized data.

Monitor and address potential biases in collected data and analytic approaches

• Describe how the DCC will perform regular data evaluations, in partnership with awarded IMPACT-MH projects, to identify and address potential biases, including but not limited to:
  • biases in datasets, algorithms, and applications;
  • issues related to identifiability and privacy;
  • impacts on disadvantaged or marginalized groups;
  • health disparities; and
  • unintended, adverse social, individual, and community consequences of research.

IMPACT-MH DCC management

• Describe how the DCC PD(s)/PI(s) will manage the proposed project and who will oversee the day-to-day activities (e.g., a project manager, if not a PD/PI).
• Describe the organization of the proposed DCC, including its coordination and communication functions, key personnel, reporting relationships, and a management plan for fiscal accountability and communication. Recruitment and training of personnel may also be discussed.
• Describe techniques to enhance the collaborative effort with and among the IMPACT-MH projects to ensure efficient cooperation, coordination, and resource sharing.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded 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 NIMH, 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 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 Estimation Tool 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 web site and give the link to the following site https://nda.nih.gov/contribute/contribute-data.html. 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 SF424 (R&R) Application Guide.

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

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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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 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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential 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 SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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 policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the 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.
  

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

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

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 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 the NIH as defined below.

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

• Define the details of the project within the guidelines of this NOFO.
• Assume responsibility and accountability to the applicant organization and to NIH for performance and proper conduct of all research in accordance with the Terms and Conditions of Award.
• Accept close coordination, cooperation, and participation of NIH program staff in the scientific, technical, and administrative management of the grant.
• Provide milestones for the grant to NIH program staff as requested (usually at the onset of the award and annually thereafter, but also at other times as requested).
• Provide periodic progress reports summarizing IMPACT-MH DCC activities and achievement of project milestones to NIMH staff as requested.
• Chair and coordinate the activities of the IMPACT-MH Steering Committee. The Chair is responsible for preparing meeting agendas, scheduling and chairing meetings, and preparing concise minutes which will be delivered to Steering Committee members within 2 weeks of the meeting. Virtual meetings are appropriate.
• Serve as a member of the Steering Committee and fulfill related duties outlined below in Areas of Joint Responsibility; inform the NIMH Program Official of all major interactions with other members of the Steering Committee.
• Adhere to NIMH policies regarding intellectual property and other policies that might be established during the course of this project activity. Recipients will retain custody of and have primary rights to the software developed under the U24 awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
• Deposit all novel subject-level data generated by the IMPACT-MH DCC, as well as data collected at IMPACT-MH project sites, in the NIMH Data Archive (see NDA;?https://data-archive.nimh.nih.gov/). All data will be deposited into NDA biannually
• Appropriately acknowledge NIMH support in publications or oral presentations of work done under this agreement, including the assigned cooperative agreement award number.
• Share data and resources according to the data release and resource sharing policies developed for and by this project as appropriate and consistent with achieving the goals of the project.
• Fully disclose algorithms and software source code as necessary to the IMPACT-MH projects for the purpose of scientific evaluation.
• Not disclose confidential information obtained from the IMPACT-MH projects.
• Submit data for quality assessment and/or validation in any manner specified by the Steering Committee and/or the NIMH program staff to ensure scientific rigor.
• Accept and implement the common guidelines and procedures approved by the Steering Committee and NIMH.
• Provide updates at least annually on implementation of the PEDP.

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

• An NIMH Program Officer will be named on the award notice. The Program Officer will be responsible for the normal scientific and programmatic stewardship of the award, including programmatic monitoring and assistance in the coordination of the overall project and implementation of the data and research resource sharing plans, and will be named in the award notice. The Program Officer may attend Steering Committee meetings as a non-voting participant.
• One or more extramural NIH program staff member(s) will be assigned as the Project Scientist(s) for this award. The same person may serve as the Project Scientist for multiple IMPACT-MH awards. The Project Scientist(s) will interact scientifically with the PDs/PIs and other named personnel of that award, as a partner in the research, including providing technical assistance, advice, and coordination for IMPACT-MH and its component parts. However, the role of NIH staff will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus of the IMPACT-MH Steering Committee and that NIH staff will be given the opportunity to offer input to this process. One NIH Project Scientist will participate as a member of the Steering Committee and will have one vote.
• The NIH Project Scientist will facilitate interactions between the IMPACT-MH DCC, the Steering Committee and recipients of NIMH NOFO, RFA-MH-23-105.
• The role of the NIH Project Scientist is to assist, participate in deliberations, and facilitate discussion, but not to direct activities. This level of staff involvement does not alter the recipient’s dominant role and prime authority in conducting the activities of the IMPACT-MH DCC. The NIMH Project Scientist may cooperate with the recipient as author or co-author of resulting publications in accordance with publication policies developed by the Steering Committee. Publications involving NIMH staff must follow NIH and NIMH publication policies.

Areas of Joint Responsibility include:

A Steering Committee will be established to assist in ensuring that the IMPACT-MH DCC provides the necessary support for IMPACT-MH projects and to monitor progress over time.?The Steering Committee will be composed of the DCC PD(s)/PI(s); the NIMH Project Scientist(s); PD(s)/PI(s) of the IMPACT-MH projects that will be funded under the companion announcement?RFA-MH-23-105; and additional members with expertise in the overall goals of the IMPACT-MH initiative. Experts in learning health care, measurement-based treatment, health information technology, health informatics, computational modeling, bioethics, and other areas may also be included, as appropriate.

Steering Committee members will meet periodically, but not fewer than twice per year, to plan research activities, review study progress, and establish priorities, policies, and procedures. Each member will have one vote on any decision to be made by the Steering Committee with respect to study policies and procedures.?The NIMH Project Scientist(s) will be a voting member of the Steering Committee. Adoption of policies and procedures will require a majority vote.?

NIMH Program Officials may attend Steering Committee meetings as non-voting participants.

The IMPACT-MH Steering Committee will have involvement in any DCC planned analyses that utilize data collected at IMPACT-MH project to ensure that data are used and interpreted according to the intent with which they were collected.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: 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 DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

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

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

Jenni Pacheco, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3645
Email:jenni.pacheco@nih.gov

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

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

Section VIII. Other Information

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

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