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

Background?
 

NIH BRAIN INITIATIVE 

Since 2014, the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative has aimed to accelerate the development and application of innovative neurotechnologies, enabling researchers to produce a new dynamic picture of the brain that reveals how individual cells and complex neural circuits interact in both time and space. It is expected that these advances will ultimately lead to new ways to treat and prevent brain disorders.

As one of several federal agencies involved in the BRAIN Initiative, NIH's contributions to the BRAIN Initiative were initially guided by "BRAIN 2025: A Scientific Vision," a strategic plan that detailed seven high-priority research areas. This plan was updated and enhanced in 2019 by: "The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures" and "The BRAIN Initiative and Neuroethics: Enabling and Enhancing Neuroscience Advances for Society." This and other BRAIN Initiative Notice of Funding Opportunity (NOFOs) are based on this vision and issued with input from Advisory Councils of the 10 NIH Institutes and Centers supporting the BRAIN Initiative, as assisted by the NIH BRAIN Multi-Council Working Group.

The NIH BRAIN Initiative 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.

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

• Transdisciplinary research projects and collaborations among neuroscientists and researchers from fields such as computational biology, physics, engineering, mathematics, computer and data sciences, as well as bioethics.
• 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 traditionally 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.

The NIH also encourages businesses to participate in the BRAIN Initiative. It is possible for companies to submit applications directly to BRAIN Initiative program announcements or to collaborate with academic researchers in joint submissions. Small businesses should consider applying to one of the BRAIN Initiative small business NOFOs.

The BRAIN Initiative requires a high level of coordination and sharing between investigators. It is expected that BRAIN Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings and in other activities such as the annual BRAIN Initiative meeting. The data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010.

Brain Behavior Quantification and Synchronization (BBQS)

The two BRAIN Initiative 2.0 reports ("The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures" and "The BRAIN Initiative and Neuroethics: Enabling and Enhancing Neuroscience Advances for Society") highlight that a critical step forward is to study “the brain in action,” including efforts to develop “tools to analyze naturalistic (untrained) and trained behaviors” and “to assimilate and link brain recordings with behavior” (p. 34 of "The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures"). Matching the scientific rigor and precision of measurements of brain activity with equally precise, temporally dense measurements of the functional output of the brain, as expressed in a broad range of behaviors, will accelerate the discovery of brain-behavior relationships in both health and disease. Achieving a comprehensive understanding across these levels of analysis demands the same level of rigor, precision of measurement, and temporal resolution across all levels.

At present, tools for measuring behavior in humans and other species lack the necessary precision and resolution to fully capture behavioral dynamics synchronously with data from the environment with which the organism is interacting and which shapes the behavior under study. To address this gap, the BRAIN Initiative BBQS funding opportunities (e.g. RFA-MH-22-240 and RFA-DA-23-030) support 1) development of tools for simultaneous, multimodal measurement of behavior within complex, dynamic physical and/or social environments and align these data with simultaneously recorded neural activity, and 2) development of novel conceptual and computational models that capture dynamic behavior-environment relationships across multiple timescales and that can integrate correlated neural activity into the model. Potential applicants and others interested in BRAIN BBQS Funding Opportunities are encouraged to visit the NIH BRAIN Initiative website for information and guidance or email [email protected].

BBQS Data Coordination and Artificial Intelligence Center (DCAIC)

The BBQS research program is characterized by certain features and challenges that need to be addressed through the creation of a multi-component, cross-discipline Data Coordination and Artificial Intelligence Center (DCAIC). First, the BBQS program will generate large amounts of multi-modality data from multiple species, including humans. This may include videographic, audiographic, electrophysiologic, temperature, and other continuous data. In addition, some projects are expected to generate data related to ambulation, limb movements, facial movements, eye movements, vocalizations, glandular secretion, and peripheral physiology. These data sets and related metadata are expected to be large in size and measured across multiple timescales. All the data will be deposited into relevant BRAIN data archive(s) to share with the community as required by the BRAIN Initiative and NIH data sharing policies (NOT-MH-19-010, NOT-OD-21-013). To manage such massive and diverse data, and to prepare the data for archiving, will be challenging. The necessary expertise includes both knowledge about how the data were measured along with access to appropriate computational and informatics tools and infrastructure. Often, individual laboratories do not have all of the needed knowledge or infrastructure. The DCAIC should be envisioned as providing a more cost/administration-efficient and process-consistent solution for such large-scale data management and preparation for archiving.

The BBQS projects will employ diverse technologies and approaches to measure and collect research data under different circumstances. It is, therefore, essential to adopt a common set of standards in the (meta)data collection, description, annotation, organization, and analysis in order to ensure consistency across different studies and to make the outcomes comparable and integrable. The DCAIC will be responsible for establishing such standards across the BBQS program through a centralized coordination effort. This will be accomplished by working together with other BBQS projects and relevant BRAIN data standards projects, with inputs from the research community and consensus from the BBQS consortium. The established standards will be of great value in strengthening data interpretability and integrability within and across the consortium, while facilitating the compliance of BBQS data with the FAIR (Findable, Accessible, Interoperable and Reusable) principles.

The BBQS program will employ a great amount of machine learning (ML) and artificial intelligence (AI) approaches in the research, which is expected to range from mapping data streams of behavior as a multidimensional response to neuronal activity, to building new conceptual models of behavioral systems, to predicting behavior that might guide intervention development or selection. It will be important for the BBQS consortium to develop a comprehensive set of ML/AI research resources. The resources will include ML/AI-ready datasets and training data, validated models, best AI practices, among others, specific to the studies. These resources will enable scientists to quickly build on and extend the results of others, and compare new experiments to state-of-the-art practices while strengthening the research rigor and reproducibility. Developing or preparing such comprehensive ML/AI resources is highly time-consuming and costly; a centralized effort by the DCAIC will be more efficient and avoid considerable duplicative efforts.

Last but not least, the BBQS program will involve extensive data processing, analysis and modeling, and large-scale computation. It will be necessary for the consortium to develop a cloud-based computational platform that is integrated with the data repository under the same set of data standards. Such an integrated data ecosystem is expected to significantly enhance analytic capability and data reusability. The ecosystem will also promote a collaborative and consistent research environment, making scientific discovery more robust and reproducible. The ecosystem will nevertheless provide a valuable learning and working environment for students and citizen scientists.

Resource Objectives

The NOFO will support a single award to a multi-disciplinary team with a single or multiple PIs to create the DCAIC. Activities directed by the DCAIC will fall into five interrelated categories:1) Data Management; 2) Data Standards; 3) ML/AI Resources; 4) Data Ecosystem; and 5) Dissemination, Training, and Coordination. Each application in response to this NOFO must address all five categories of research activities.

The DCAIC is expected to support, communicate, coordinate and collaborate with the other BBQS projects on each category of research activities. As part of this process, the DCAIC will also solicit input from various fields contributing to the behavioral and neural sciences to guide design and implementation of DCAIC components. The DCAIC is also expected to collaborate or integrate with relevant BRAIN informatics infrastructure projects, particularly data archive(s). Applicants should therefore familiarize themselves with the BBQS program (www.braininitiative.nih.gov/funding/initiatives.htm; also see the NOFOs RFA-MH-22-240 and RFA-DA-23-030), as well as the BRAIN Informatics Program (www.braininitiative.nih.gov/brain-programs/informatic; also see the NOFOs RFA-MH-20-600, RFA-MH-22-145, RFA-MH-21-135), in preparation of the application.

The DCAIC team should be multidisciplinary  and is required to include scientists that contribute, specifically, broad and deep expertise in research design and analysis of high-dimensional and/or multimodal behavioral data, and expertise in collection and analysis and of high-dimensional neural data. The PD(s)/PI(s) of the DCAIC must be experienced in the coordination and management of multiple projects.

1. Data Management

The DCAIC will work collaboratively with other BBQS projects and BRAIN data archive(s) to manage BBQS data workflows. In the workflows, the BBQS data generation projects will first submit raw and/or processed data to the DCAIC. The DCAIC will curate and process the data, conduct necessary quality assurance (QA)/quality control (QC), and then coordinate with relevant BRAIN data archive(s) to ingest and deposit the data into the archive. The data archive will further validate, index, and harmonize the data, and make the data available for use by the scientific community. In this way, the DCAIC will serve as the organizational hub for rapid and seamless data management and sharing.

Specific activities of the DCAIC in this category include, but are not limited to:

• Develop or implement data quality metrics and informatics tools or pipelines that are required for data management and preparation for archiving.
• Conduct data processing, QA/QC evaluation, harmonization, ingestion, and preparation for submission to BRAIN data archive(s).
• Integrate or link data across modalities, scales, and species within and across different studies.
• Track BBQS data workflows and provenance by establishing a dashboard and monitoring data use statistics and data users’ experience.
• Establish milestones of data submission by individual projects,
• Monitor and report to NIH the data submission and release status according to projects’ Data Sharing Plans.

2. Data Standards

The DCAIC will establish a catalog of standards required for BBQS studies (referred to as Standards4BBQS). This includes standards for data and metadata, along with data dictionaries and controlled vocabularies. This also includes domain-specific ontologies that capture various components of brain-behavior knowledge. This, in addition, includes standard operational procedures (SOPs) or best practices for data collection, processing, and analysis. As necessary, the DCAIC should leverage or re-use existing standards, ontologies, common data elements, well-established data collection approaches, data processing pipelines, and other tools which are suitable for BBQS studies. The DCAIC will furthermore be responsible for implementing the standards across different BBQS projects or research activities. Expectedly, all  will be performed through close collaboration and coordination with other BBQS projects, various working groups with domain experts, relevant BRAIN data standards projects, and the BBQS steering committee, with input from the research community and consensus from the BBQS consortium.

3. ML/AI Resources

The DCAIC will develop and deploy a series of ML/AI resources required for BBQS (referred to as AIR4BBQS). The DCAIC should target multi-modality data that are collected not only within the BBQS consortium but also by similar projects beyond the consortium and BRAIN to develop the resources. The created resources, as well as the processes for developing and preparing the resource (e.g., data curation, model training, model assessment), should be adequately documented using appropriate methods (e.g., data card, model card) to enhance transparency, accountability, and reproducibility. The models should be well validated, and the feasibility adequately tested using existing data or synthetic data. The created resources should be deposited to BRAIN data archive(s) or other public repositories and made FAIR.

Specific activities of the DCAIC in this category include, but are not limited to:

• Prepare or repurpose large-scale datasets for ML/AI analysis addressing key questions or challenges in BBQS.
• Create training or benchmark datasets for ML/AI in BBQS studies.
• Train or re-train ML/AI models that are scientifically or clinically important to BBQS studies.
• Evaluate or compare ML/AI models or create benchmark models that are relevant to BBQS goals.
• Generate rubrics that allow for evaluation of ML/AI-ready datasets for BBQS.
• Establish plans or inform best practices for generating or collecting data or repurposing existing data for BBQS ML/AI studies.

4. Data Ecosystem

The DCAIC will develop a cloud-based computational platform that is integrated with the data archive as well as data standards for a modern data ecosystem for BBQS studies. The computational platform will be implemented with a series of uniform data processing pipelines and cutting-edge software tools for data processing, analysis, visualization, harmonization, and integration, among others. The ecosystem will be powered by AIR4BBQS for ML/AI research in particular. A cloud-based interface to the ecosystem will also be created that allows investigators to access data and conduct distributed analysis or modeling near the data. The interface will also allow BBQS researchers to install or load their own tools, models, or datasets to the platform to conduct analyses. In this case, the ecosystem will provide opportunities for researchers to create data sandboxes in the platform, where investigators can test or optimize computational pipelines or software tools, and compare their codes and analysis results with others. The computational platform and ecosystem should be user-friendly and easily accessible to the community.

5. Dissemination, Training, and Coordination

The DCAIC will promote broad dissemination of BBQS research resources, such as data, tools, models, methods, and protocols, to the community. This includes coordinating resource sharing across the consortium. This also includes (but is not limited to) developing or compiling tutorials, detailed walkthroughs and other materials about consortium studies, and broadly sharing those materials with the research community. The DCAIC will also organize training activities, which are primarily targeted to investigators of the BBQS awards but can be extended to researchers from BRAIN-funded training or other relevant programs. The topics of training include (but are not limited to) data processing, curation and analysis, data standards, computation on the cloud, and using the BBQS data ecosystem. The DCAIC will, moreover, develop and maintain the BBQS Web Portal, which will constitute the main entry point to consortium information, resources, and data ecosystem for internal and external communication, dissemination and training activities. With these and other efforts, the DCAIC will facilitate and promote open science approaches to BBQS. The DCAIC will, in addition, help in the overall coordination and administration of the consortium, by working with assigned NIH staff. That coordination will include (but is not limited to) organizing meetings or/and working groups, planning for publications, and maintaining consortium-relevant workflows, protocols, and documents in a single location. The DCAIC will furthermore help in addressing policy issues related to data or resource sharing and ethical or societal concerns arising from the consortium studies, under the guidance of the BRAIN ethics team and in coordination with NIH staff.

Plan for Enhancing Diverse Perspectives (PEDP)

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

The following applications will be considered non-responsive to the NOFO and will not be reviewed:

• Applications that fail to address all five categories of research activities (i.e., data management, data standards; ML/AI resources; data ecosystem; and dissemination, training and coordination).
• Applications that propose to generate experimental data.
• Applications primarily focused on the development of software tools, computational platforms, methods, models or data standards. Such applications may consider other BRAIN Initiative NOFOs (including RFA-MH-22-145, RFA-MH-21-135).
• Applications that propose to develop data archive(s). Such applications may consider the BRAIN Initiative NOFO RFA-MH-20-600.
• Applications primarily focused on data analysis or re-analysis.
• Applications that fail to include milestones and a timeline.
• Applications that fail to include a PEDP (see details of PEDP in Section IV. Application and Submission Information).

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-19-027). The application’s Protection of Human Subjects and Clinical Trials Information and data and safety monitoring plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.

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

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

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 Government

• Eligible Agencies of the Federal Government including the NIH Intramural Program
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Applicant Organizations

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

• System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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: [email protected]

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.

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

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

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

Other Attachments :

Plan for Enhancing Diverse Perspectives (PEDP)

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).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

Applicants may get additional information regarding the PEDP from the PEDP Frequently Asked Questions and the Key Elements and Examples.

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

R&R Budget

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

PEDP implementation costs:

• Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

R&R Subaward Budget

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

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

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

Research Strategy

The application in response to this NOFO must address all the following five categories of research activities as part of the research strategy: 1) Data Management, 2) Data Standards, 3) ML/AI Resources, 4) Data Ecosystem, and 5) Dissemination, Training and Coordination. The description or discussion of Research Strategy will include (but not be limited to) the following areas:

• An overall strategy, operational plan, and organizational structure that are  appropriate to accomplish the goals of the DCAIC
• Gaps, challenges and state-of-the-art of relevant subjects
• A plan for transferring data from data generation projects to the DCAIC, conducting data management, validation and preparation, and depositing the curated data to data archive(s)
• A plan to develop and deploy data standards, ontologies, and best practices for BBQS
• A plan to develop, document and disseminate ML/AI resources
• A plan to establish a cloud-based computational platform and data ecosystem, along with the interface
• A plan for developing and carrying out broad dissemination, training, and coordination activities  that support the BBQS consortium mission
• A plan to implement FAIR data principles
• How the proposed plans leverage current best practices or existing tools or methods, or integrate existing approaches in novel ways to support the goals of the DCAIC
• How and why the proposed approaches are optimal in contributing to the goals of the DCAIC
• Relevant preliminary results

Applications are expected to present their plans on how to support, communicate, coordinate and collaborate with the other BBQS projects, and on how to collaborate or integrate with BRAIN data archive and other informatics infrastructure projects based on their best knowledge.

The application should reflect the team's multidisciplinary background and expertise in different areas of BBQS studies, with at least one neuroscientist with expertise in high-dimensional behavioral data collection and analysis. The application should detail the DCAIC PD(s)/PI(s) experience in the coordination and management of multiple projects, cloud-based data analysis, and data and resources dissemination. The roles and responsibilities each PD/PI and key personnel must be well-defined.

 Applications should include a timeline for carrying out the research activities of the DCAIC that includes clear quantitative milestones. Milestones should cover all five categories of research activities.

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:

The following modifications also apply:

• 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.
•  The data sharing expectations for BRAIN Initiative awards requires that the data is deposited to relevant data archives developed by the BRAIN Initiative. Applicants can refer to NOT-MH-19-010 for more information about BRAIN Initiative data sharing information
• Applications should provide a detailed plan for transferring, managing, and depositing data into the BRAIN data archive(s) in the Research Strategy section of the application. The plan should ensure that the data are FAIR (i.e., findable, accessible, interoperable and reusable).
• Research resources generated by the BBQS projects include research tools, models, protocols, technologies, reagents, user manuals, preprints, among others. The resources should be made rapidly available to the research community. The rapid dissemination of the resources will accelerate scientific exploration, enhance research rigor and reproducibility, and avoid duplicative resource development efforts. The application should provide specific plans for sharing and distributing the resources via open repositories. NIH staff will be responsible for any additional administrative review of the plan for sharing resources and may negotiate modifications of the plan with the prospective awardee prior to award. The final negotiated version of the resource sharing plan will become a term and condition of the award of the cooperative agreement.

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

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

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

Foreign Institutions

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

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

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

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications must include annual milestones covering all the five categories of research activities. Applications that fail to include annual milestones and a timeline will be considered incomplete and will be withdrawn before review. Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review.

Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this NOFO. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourages 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

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.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

Does the proposed Center address the needs of the research consortium that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Specific to this NOFO:

• How well do the proposed aims and research plans align with the DCAIC goals in the areas of data management, data standards, ML/AI resources, data ecosystem, and dissemination, training and coordination?
• To what extent  will the proposed DCAIC advance the management, analysis, sharing and dissemination of data from research employing high-resolution, multi-disciplinary approaches to capturing and analyzing multiple dimensions of behavior (including gross and fine movements, location, vocalization, peripheral physiologic changes)?
• How adequately does the project address important challenges in implementing FAIR data principles?
• To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing collaborative research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Specific to this NOFO:

• How well  the proposed DCAIC team demonstrate multidisciplinary expertise and a track record of hands-on involvement in management, coordination, cloud-based data analysis, and data and resources dissemination?
• To what extent does the application reflect the team's background in different areas of BBQS studies?
• To what extent does  the team include at least one scientist with expertise in high-dimensional behavioral data collection and analysis?
• To what extent does  the team include a neuroscientist with expertise relevant to the proposed data archive(s)?
• How well are  the roles and responsibilities each PD/PI and key personnel well-defined?
• To what extent are  the PD(s)/PI(s) and other key personnel devoting sufficient time/effort to achieve the goals of the proposed project?
• To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

Innovation

Does the application propose novel organizational concepts in coordinating the research program the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts proposed? 

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Specific to this NOFO:

• How adequately does  the application describe plans to employ unique or novel methodologies to meet the goals of the DCAIC?
• How well does the DCAIC plan leverage current best practices, use existing tools or methods, or integrate existing approaches in novel ways to support the goals of the DCAIC?
• To what extent does  the application include a plan to deploy cloud-based computational platform appropriate for analysis or visualization of BBQS data types?
• To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Is an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

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

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable?

Study Design

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Specific to this NOFO:

• How well does  the application include an organizational structure which is likely to ensure that the diverse DCAIC activities are well-coordinated?
• How well does  the application provide a strategy for processing and managing BBQS data and uploading the raw and/or derived data to the BRAIN data archive(s)?
• How adequately has the application presented appropriate methods and plans to create ML/AI resources and ??????adequately document the created resources and their preparation procedures?
• To what extent does  the proposed computational platform include robust and efficient informatics infrastructure and state-of-the-art software tools and pipelines that are required by BBQS studies?
• To what extent will the proposed data ecosystem, as well as the cloud-based interface, be easily accessible and user-friendly?
• How strong is the plan for the DCAIC to work with the other BBQS projects and BRAIN informatics infrastructure projects?
• How strong is the plan for soliciting and assimilating input from the behavioral sciences and neuroscience communities?
• To what extent will the proposed DCAIC help create a scalable data ecosystem that can be accessed and used to create novel, integrated datasets to be used by behavioral and neural scientists for secondary data analysis?
• How strong is the plan for developing and carrying out dissemination, training and coordination activities of the DCAIC?
• Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Specific to this NOFO:

• To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

Additional Review Criteria

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

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable 

Revisions

Not Applicable 

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

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities including the PEDP.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this 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.

The NIMH has published policies and guidance for investigators regarding human research protection, data and safety monitoring, Independent Safety Monitors and Data and Safety Monitoring Boards, reportable events, and participant recruitment monitoring (NOT-MH-19-027). The application’s PHS Human Subjects and Clinical Trials Information should reflect the manner in which these policies will be implemented for each study record. These plans will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. The NIMH will expect clinical trials to be conducted in accordance with these policies including, but not limited to: timely registration to ClinicalTrials.gov, submission of review determinations from the clinical trial’s data and safety monitoring entity (at least annually), timely submission of reportable events as prescribed, and establishment of recruitment milestones and progress reporting.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

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 condition of receiving the grant, to administer 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. 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 2 CFR 200, 45 CFR Parts 75, 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 award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipient 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 responsibilities as described below:

• Oversee and perform the scientific activities within the guidelines of this NOFO.
• Provide scientific and administrative leadership of the DCAIC.
• Serve as a member of the DCAIC Steering Committee, and attend the meetings.
• Implement common guidelines and procedures approved by the Steering Committee and NIH.
• Adhere to NIH policies regarding intellectual property and other policies that might be established during the course of the study.
• Not disclose confidential information obtained from other members of the consortium.
• Share data and resources according to the established data and resource sharing policies.
• Participate in BBQS consortium activities, including periodic meetings.
• Accept close coordination, cooperation and participation of NIH program staff in the scientific, technical and administrative management of the DCAIC. Inform the NIH program official of all major interactions with the rest of the community.
• Provide milestones and cost for the grant to the NIH program staff as requested (usually at the outset of the award and annually thereafter, but also at other times as requested by the program staff).
• Provide periodic progress reports summarizing DCAIC research activities and milestone progress to NIH staff as requested.
• Provide updates at least annually on implementation of the PEDP.
• Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding 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:

Program Officer: A Program Officer will be assigned to this award. Program Officer will be responsible for routine scientific and programmatic stewardship and guidance for the entire project. Program Officer will also negotiate milestones with the PD(s)/PI(s) and ensure that the milestones are achieved and goals are being met. Program officer will moreover be responsible for monitoring the agreed data and resource sharing plans and timelines. Program officer will in addition participate in Steering Committee meetings, working group meetings and other relevant meetings of the DCAIC.

Project Scientist: A Project Scientist will also be assigned to this award. Project Scientist will interact scientifically with the PD(s)/PI(s) and other personnel of the DCAIC as a partner in the research, and provide technical assistance, advice, and coordination for the project. Project Scientist will be a member of the Steering Committee and participate in the meeting of the Committee as well as other meetings of the DCAIC.

Project Team: A group of NIH program staff from different ICs that make up the NIH BRAIN Initiative will form a Project Team for the BBQS consortium. The Project Team will include the Program Officers and Project Scientists of the DCAIC and other BBQS awards. The Project Team will review annual progress reports and other documents from the recipient of the DCAIC, and will advise the Program Officer about their view of the progress being made by the recipient of DCAIC along with those by recipients of other BBQS projects.

Areas of Joint Responsibility include:

A Steering Committee will be established for this award. The Committee will be composed of the PD(s)/PI(s) of this award and other awards of the BBQS consortium, the PD(s)/PI(s) of the BRAIN data archive(s) relevant to the BBQS consortium, along with the NIH Program Officers and Project Scientists of all these awards. If necessary, the PD(s)/PI(s) and Program Officer of the DCAIC will invite external experts to be part of the Committee, after the award. The Committee will be chaired by the PD/PI of the DCAIC or other BBQS projects as designated by the Committee.

The Steering Committee will help in planning and designing activities of the DCAIC, establishing research priorities, optimal research designs, project milestones and policies, reviewing and discussing the progress, and suggesting improvements. The Committee will also help in establishing working groups as needed to address particular issues and interests in BBQS studies. The Committee will moreover help in coordinating the activities of the DCAIC and other BBQS projects, and distributing research resources to a wider scientific community. The Committee will nevertheless help in communicating with recipients of the BRAIN Initiative more broadly in order to achieve the goals outlined in the BRAIN 2025 and BRAIN 2.0 reports.

The Steering Committee will meet periodically. The Committee Chair will be responsible for developing meeting frequency and agenda, and chairing the meetings. Expectedly most of the decisions by the Committee will be reached by consensus. If a vote is needed, each Committee member will have one vote, except for the NIH Program Officers and Project Scientists, who collectively will have one vote.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. These three members include: a designee of the Steering Group 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 1.

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 $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Section VII. Agency Contacts

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Ming Zhan, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3678
Email: [email protected]

 

Nicholas Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]

Heather Weiss
National Institute of Mental Health (NIMH)
Telephone: 301-443-4415
Email: [email protected]

Section VIII. Other Information

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

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