Part 1. Overview Information

Key Dates

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

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

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

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

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The 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 Funding Opportunity Announcements (FOAs) 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 historically underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031 and https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp).

• 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 FOAs.

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 PI meeting. The data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010.

Brain Behavioral Quantification and Synchronization (BBQS) Funding Opportunities

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 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 https://www.braininitiative.nih.gov/funding/initiatives.htm or contact BBQS at BRAINBBQS@od.nih.gov.

BBQS Transformative and Integrative Models of Behavior at the Organismal Level

Behavior, i.e., how an individual responds to and/or interacts with his/her/their environment, is a critical determinant of health and a major mediator of morbidity for nearly all diseases. To fully understand behavior as a determinant of health and disease, it is necessary not only to elucidate the biological mechanisms underlying behavior but also to understand how behavior and its underlying mechanisms are shaped by their adaptive significance (positive or negative) to the development of the individual and to the evolution of the relevant population/species. Moreover, an understanding of how brain-body-behavior relationships are conserved or divergent across species is critical for the rigorous use of non-human species to model aspects of human neurobehavioral function in health and disease.

The goal of this NIH BRAIN Initiative BBQS funding opportunity is to support the design of research that will advance behavioral science through: 1) Integration of theoretical frameworks guiding the study of behavior, its underlying mechanisms, and adaptive value; 2) Acceleration of the development and/or adoption of technologies and methods for objective, high-resolution measurement of behavior at the level of the organism and its environment; 3) Development of sharable standards and archives for behavioral data; and 4) Development of new computational models that capture the behavior-environment interface as a complex dynamic system.

Research Objectives and Scope

The primary goal of this R34 FOA is for planning purposes and other activities that support the development of a basic science research project that will be the basis of a competitive application for a U01, R01 or similar NIH research award. The specific objectives and activities for the proposed R34 planning project can include establishment of the research team, designing of the research, development of tools for behavioral measurement, data management and analysis and/or research oversight, establishment of data standards, validation of outcome measures, preparation and approval of protocols, and pilot studies to establish feasibility and/or to collect preliminary data necessary to support a competitive application for a U01, R01 or similar NIH research award.

The planned research should be designed to address the following major objectives:

1. Building an interdisciplinary, functionally diverse, team including scientists and engineers from fields including but not limited to neuroethology, evolutionary biology, neurobiology, behavioral ecology, anthropology, the social sciences, cognitive neuroscience, neurocognitive development, biokinetics, bioengineering and ethics; with the shared goal of integrating conceptual and methodological approaches to measuring and modeling behavior.
2. Establishing the feasibility of the development, adaptation and/or validation of sensing technology that allows synchronous measurement of multiple variables that capture the multidimensional and dynamic nature of behavior of an organism interacting with its social and/or physical environment, more specifically:
   • Methods and tools for synchronous, high-temporal-resolution measurement of multiple modalities of behavior including but not limited to limb, facial and/or eye movements, ambulation, vocalizations, sniffing; as well as coordinated autonomic and peripheral physiological changes (e.g., glandular secretion; changes in heart rate, blood insulin or glucose levels) that allow for natural, minimally impeded expression of behavior.
   • Simultaneous with the measurement of behavior, capture of environmental changes including but not limited to affiliative, antagonistic, or predatory social signals, stimuli that predict availability or quality of resources (e.g., food, safety) or signal threat, and/ or other discreet stimuli or continuous changes in the environment (e.g., temperature, lighting, social and non-social sounds, olfactory signals) biologically relevant to the organism.
3. Establishing the framework for a testable conceptual and/or predictive or testable statistical/computational model (including machine learning/AI methods) that will integrate multimodal behavioral and environmental data across multiple temporospatial scales, and will be designed with the capacity to integrate correlated neural data.

Developmental frameworks and comparative approaches are encouraged. This R34 RFA is intended to stimulate fundamental basic research; and while such research may generate insights relevant to neurobehavioral disorders, this RFA is not intended to stimulate research that is disease-related.

Additional information relevant to the planning of research involving human subjects

This R34 can be used for the planning of a research project that includes basic experimental studies with humans (BESH). However, this R34 is not intended to support research activities that meet the NIH definition of a Clinical Trial, including BESH research. See the following links for information on NIH Clinical Trial Requirements, Definitions, and, specifically, BESH research.

In the design of studies that will involve human subjects or use of human subject data, the analytic and ethical challenges of collecting, archiving and analysis of subject-level data are to be considered. Applicants planning to include human subjects research or use of human data are strongly encouraged to consult the Scientific/Research Contact listed below.

Plan for Enhancing Diverse Perspectives

This FOA requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the FOA 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 and will be considered as part of the scientific and technical merit of the proposed project in making funding decisions.

Planning proposals considered to be responsive to this RFA could be used to plan research projects addressing the following representative, but not exhaustive, research objectives:

• Development, novel application, or adaptation of hardware and/or software tools that advance novel methods to simultaneously capture and quantify multiple observable dimensions of behavior including but not limited to ambulation, limb, head, facial and/or eye movements, sniffing, vocalizations, glandular secretion, and peripheral physiology. Goals for adaptation of a sensing technology can include reducing the burden that sensing devices place on the organism and/or improving the temporal resolution and sampling duration, data storage capacity, and/or quality of data analysis

• Development or novel application of hardware and/or software tools to advance measurement of environmental changes (including stimuli or signals presented to and/or detectable by the organism) for the purpose of synchronous collection and integration of that data with behavioral data.
• Development of novel analytic tools and statistical and/or computational approaches (e.g., ML/AI methods) with the capacity to integrate multiple arrays of data from processes occurring across a wide range of timescales
• Development of novel data science approaches to integrate multiple data modalities and/or data streams (e.g., integration of behavioral measures from different domains and/or of peripheral biophysiological measures with complex behaviors)
• Development of novel conceptual or computational frameworks that incorporate multiple data arrays representing the organism’s response to environmental change, and that can detect relationships across a range of timescales (e.g., milliseconds to days) within and across data streams
• Use of existing data and/or synthetic data to help validate or assess feasibility of sensor methodology and/or computational models based on the integration of multidimensional behavioral and environmental data aimed at modeling the interrelated dynamics of behavior and the surrounding environment as a complex system
• Approaches that integrate multidimensional behavioral and/or environmental data with synchronous measures of neural activity

Topics and activities considered not to be responsive to this FOA, and that may disqualify the application from review, include the following:

• Studies measuring behavior solely as a proxy for an internal cognitive or affective process

• Studies exclusively measuring neural activity or in which behavioral output is measured primarily as a function of neural activity

• Studies in which movement and/or other behavior of the subject is highly restricted (e.g., head-fixed or chair-restrained preparations) or behavioral outcome measures consisting of highly trained or stereotyped responses (e.g., isolated arm or eye movement) or are otherwise unidimensional
• Studies that do not include activities that work toward a conceptual or computational model of behavior and the organism’s environment as an interactive system
• Studies that are primarily focused on the modeling of a neurobehavioral disorder or psychopathology
• Applications lacking the required one-page PEDP plan.

Prior Consultation with IC staff

Applicants are strongly encouraged to consult the Scientific/Research Contact listed below to discuss the alignment of their proposed work with the goals of this FOA and the BRAIN Initiative Program

Resource Sharing

Applications should include activities to develop a data and resource sharing plan for the planned research project.

The data sharing plan must address the NIH Data Management and Sharing Policy. To learn what NIH expects to be addressed in Data Management & Sharing plans, see https://sharing.nih.gov/data-management-and-sharing-policy/planning-and-budgeting-DMS/writing-a-data-management-and-sharing-plan.

In addition, the resource and data sharing plan should address BRAIN Initiative expectations for data sharing (see NOT-MH-19-010) and include participation in post-award activities (e.g., BRAIN Initiative investigator meetings) designed to increase sharing of resources, data, protocols, and other information for BRAIN Initiative awardees.

Special considerations?

Please see Special Considerations for NIDA Funding Opportunities and Awards at https://www.drugabuse.gov/funding/special-considerations-for-nida-funding.

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

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

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

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

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

Applicant Organizations

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

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and 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 his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Email: NIDALetterofIntent@mail.nih.gov

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

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

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 application 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 historically 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.

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

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

R&R or Modular Budget

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

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).

Data and Resource Sharing Costs

• Under the NIH Data Management and Sharing Policy (eff January 25, 2023) and consistent wtih BRAIN Initiative expectations, applicants should include in the budget the costs associated with activities necessary to build the data management and sharing plan for the planned project. For information on allowable costs for data management and sharing, see https://sharing.nih.gov/data-management-and-sharing-policy/planning-and-budgeting-DMS/budgeting-for-data-management-sharing#after.

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

Consistent with NIH BRAIN Initiative goals, applications must balance innovation and advanced thinking and methodology with convincing tractability and potential impacts. Applications are allowed to include preliminary data, but this is not a requirement.

Key elements of the activities supported by this R34 planning project

• The applicant should indicate how the proposed R34 activities will lay the groundwork for a future Team R01/U01 (or project of similar scale) relevant to the mission of the BRAIN Initiative. Specifically, the application must describe how the aims and approach of the proposed R34 will establish feasibility, validity, or other technically qualifying results that, if successful, would support, enable, and/or lay the groundwork for a competitive Team R01/U01 or similar application.

• The planned project should address the three major objectives described above and be informed by multiple behavioral science frameworks or approaches (e.g., cognitive neuroscience, developmental psychology, evolutionary biology, ethology, behavioral ecology, complex systems research). Use of developmental frameworks and/or comparative approaches are encouraged.

• Applications should include milestones, specifically addressing how the planned activities contribute to the development of a full-scale project that would be the basis of a competitive application for a larger research project grant (e.g., Team U01 or R01). The milestones should address the three major objectives described above.

• The plan should include quality assurance processes for data collection, annotation, open source/open sharing, and dissemination.
• Although planned projects are not required to include neural activity data, software tools and computational models generated as part of the planned research should be designed to ultimately integrate neural data, anticipating advances in methods for capturing neural data from freely moving animals in ecologically relevant conditions.
• The plan should address the potential for harmonization of the data generated by the planned project with existing neural data archives, including data collected by BRAIN Initiative-supported projects.
• If included, neural data must be an integral component of the proposed model of organismal behavior in the context of a dynamic social or physical environment.
• The project team should be multi-disciplinary, with scientists and engineers from fields including but not limited to neuroethology, evolutionary biology, behavioral ecology, anthropology, the social sciences, cognitive neuroscience, neurocognitive development, biokinetics, bioengineering and ethics. Team members should bring diverse perspectives on and expertise in observing, measuring, and modeling behavior.
  • The team must include substantial expertise in neuroscience and computational modeling
  • If the planned project will involve human subjects research or analysis of human data, the team must include an ethicist.
• For applications planning projects using multiple species, the applicant should address how the selected species offer the best conditions for revealing general principles about the behavioral domain of interest or offer optimal conditions for development of approaches for capturing multiple dimensions of behavior and peripheral physiology at the level of the organism
• If the planned project will involve human subjects or data, the plan must consider the analytic and ethical challenges of collecting, archiving and analysis of subject-level data, including privacy; as well as other considerations and principles foundational to ethical conduct of research involving human subjects or human data.

Rigor and Reproducibility

Proposed research plans must incorporate NIH standards of rigor, transparency and reproducibility as elaborated in NOT-OD-16-011, NOT-OD-16-031 and NOT-OD-18-228. Additional information can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-011.html and related announcements, and must comply with NIH policy on consideration of sex as a biological variable (SABV) as elaborated in NOT-OD-15-102, NOT-OD-15-103, NOT-OD-16-011 and NOT-OD-16-031. Additional information on SABV can be found at https://orwh.od.nih.gov/sex-gender/nih-policy-sex-biological-variable.

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.

The following modifications also apply:

All applications submitted in response to this FOA must include as part of the planned project, a data and resource management and sharing plan that complies with the NIH Data Management and Sharing Policy, effective as of January 25, 2023. More information on NIH's expectations for data management and sharing under this policy can be found at https://sharing.nih.gov/data-management-and-sharing-policy/about-data-management-and-sharing-policy/data-management-and-sharing-policy-overview#after.

To meet expectations of the BRAIN Initiative, the resource sharing plan should address the following specific components.

• A summary of the resources that will be shared
• A description of the standard(s) that will be used to describe the resource(s)
• Archive(s) that will house the resource(s)
• A proposed timeline for submitting resource(s) to the archive and sharing them with the research and medical communities, if appropriate
• A potential plan for technology transfer and/or patent capabilities of the resource(s)

Data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

Foreign Institutions

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

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

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

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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.

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

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

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.

For this particular announcement, note the following:

The R34 mechanism supports a limited scope of activities, including exploratory research, with the goal of developing a research plan that would support and/or lay the groundwork for a potential U01 or R01 or similar NIH award. The impact of these R34 applications will be reviewed on the bases of:

1. The potential impact of the planned (i.e., future R01 or U01-supported) research project, if successful, with respect to the goal of BBQS Transformative and Integrative Models of Behavior at the Organismal Level.
2. The effectiveness of the R34 activities in establishing support for the scientific rationale underlying the project; or establishment of feasibility, validity, or other technically qualifying results in supporting or laying the groundwork for a potential U01 or R01 award, or equivalent.

Applicants are not expected to propose fully powered experiments or the complete testing of hypotheses as part of this R34 application.

While fundamental basic research often generates insights relevant to disorders of the nervous system, this RFA is not intended to stimulate research that is explicitly disease-related.

Overall Impact

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

Scored Review Criteria

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

Significance

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

Specific to this RFA,

• To what degree do the planning activities supported by the R34 lay the groundwork for a project that will address the major objectives of BBQS Transformative and Integrative Models of Behavior at the Organismal Level, specifically:

• • Building an interdisciplinary and functionally diverse team with the goal of integrating conceptual and methodological approaches to measuring and modeling behavior
  • Establishing the feasibility of the development, adaptation and/or validation of sensing technology that allows synchronous measurement of multiple variables that capture the multidimensional and dynamic nature of behavior of an organism interacting with its social or physical environment
  • Establishing the framework for a conceptual and/or statistical/computational model (including machine learning/AI methods) that integrates multimodal behavioral and environmental data across multiple temporospatial scales.

• What is the potential for the planned activities to enable a future R01/U01 or similarly scaled project that, if the aims are achieved, advances the overarching goal of the NIH BRAIN Initiative?

• To what extent do the efforts describe in the Plan for Enhancing Diverse Perspectives further the significance of the project?

Investigator(s)

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

Specific to this RFA,

• How is the overall quality of the proposed planning project impacted by the diversity among team members with respect to racial, ethnic, cultural, gender and other biological or social dimensions of background and identity; philosophical perspective; educational background, professional experiences and career stage; general and specific scientific expertise; and other competencies relevant to the proposed project?
• Is expertise in the areas of neuroscience and computational modeling represented on the team?
• If human subjects or data will be included in the planned project, does the team include a member whose primary area of expertise is neuroethics or related field within ethics?
• 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 challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this RFA,

• To what extent do the planning activities conducted within the scope of this R34 draw from multiple disciplines and perspectives to create or advance a process for team science project development?
• To what degree will the planning activities conducted within the scope of this R34 increase the potential for innovation in the planned project with respect to
  • development or adaptation of sensing technology, software tools and/or computational modelling approaches to advance the study of behavior in the context of a dynamic social or physical environment?
  • development of innovative tools and/or methods to advance conceptual and/or computational modeling of behavior to integrate multiple types of environmental and behavioral data and/or integrates theories on behavioral function?
• To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Approach

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

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

Specific to this RFA,

• How well do the R34-supported activities create and support a team structure and process that assure that different perspectives of the team will inform the project?
• How well do the proposed R34 activities lay the groundwork for a future Team R01/U01 (or project of similar scale) relevant to the goals of the BRAIN Initiative? Specifically, how well does the applicant address how the aims and approach of the proposed R34 activities will establish feasibility, validity, or other technically qualifying results that, if successful, would support, enable, and/or lay the groundwork for a competitive Team R01/U01 or similar application?

• To what degree do the planned activities supported by the R34 lay the groundwork for development, novel application, or adaptation of hardware and/or software tools to simultaneously capture and quantify multiple observable dimensions of behavior (e.g., ambulation, limb, head, facial and/or eye movements, vocalizations, sniffing, glandular secretion, and peripheral physiology) and relevant stimuli, signals, or other changes in the organism’s environment?
• How well do the planning activities address the goal of capturing multiple dimensions of behavioral and physiological data from the organism in context of an ecologically relevant dynamic environment?
• How well do the planning activities address the potential impact of the approaches to be used in the planned project on the organism’s behavior? Do the planning activities increase the likelihood that the planned project will lead to less intrusive methods for capturing behavior than are currently widely available?
• How well do the planning activities address data storage and analysis appropriate for the data to be collected in the planned project? Do the planning activities lay the groundwork for a project that will develop a conceptual or computational model that will integrate multidimensional behavioral data and environmental data, and the potential to integrate neural data and/or harmonize with existing neural data sets or models of brain function?
• Are quality assurance processes for data collection, annotation, open source/open sharing, and dissemination addressed as part of the planning process supported by this R34?
• If the activities to be supported by the R34 include validation of an approach, how rigorous and/or quantifiable are the proposed criteria for validation? How amenable are the validation plan and criteria to replication?
• If the planned (i.e., prospective U01, R01 or similar-scale) project will involve human subjects or data, how well do the planning activities consider potential bias, privacy and other considerations and principles foundational to ethical conduct of research involving human subjects or human data?

• How well-developed and feasible are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives ?

Environment

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

Specific to this RFA,

• How well is the environment suited to designing and executing successful Team Science, i.e., project planning and execution by and for a multi-disciplinary, functionally diverse research team?
• How well do the planning activities create a process and an environment that will sustainably support successful interdisciplinary team science? How well do the planning activities address potential barriers to team science, including logistical or other barriers associated with multi-institutional and/or private-public collaborations?
• 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.

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 Animal 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 following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Specific to this FOA, reviewers will comment specifically on whether the data sharing plan meets NIH's expectations for data management and sharing (see https://sharing.nih.gov/data-management-and-sharing-policy/about-data-management-and-sharing-policy/data-management-and-sharing-policy-overview#after), as well as the expectations of the BRAIN Initiative. Reviewers will comment on whether the sharing plan addresses and/or includes the following components:

• A summary of the resources that will be shared

• A description of the standard(s) that will be used to describe the resource(s)

• Archive(s) that will house the resource(s)

• A proposed timeline for submitting resource(s) to the archive and sharing them with the research and medical communities, if appropriate

• A potential plan for technology transfer and/or patent capabilities of the resource(s)

Full information about data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

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

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

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 National Advisory Council on Drug Abuse (NACDA). The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

2. Administrative and National Policy Requirements

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

• Federalwide 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 must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/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 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.

Not Applicable

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.

3. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

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

Section VII. Agency Contacts

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

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

Finding Help Online: http://grants.nih.gov/support/ (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: 301-945-7573

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

Holly Moore, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-7376
Email: holly.moore@nih.gov

Dharmendar Rathore, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6965
Email: dharmendar.rathore@nih.gov

Ericka Wells
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6705
Email: ericka.wells@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.