Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Center for Complementary and Integrative Health (NCCIH)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title
BRAIN Initiative: Brain-Behavior Quantification and Synchronization – Transformative and Integrative Models of Behavior at the Organismal Level (R34 Clinical Trial Optional)
Activity Code

R34 Planning Grant

Announcement Type
Reissue of RFA-DA-23-030
Related Notices
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Funding Opportunity Number (FON)
RFA-DA-24-042
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.279, 93.866, 93.867, 93.853, 93.286, 93.213, 93.865, 93.173, 93.273, 93.242
Funding Opportunity Purpose

This notice of funding opportunity (NOFO) seeks applications proposing a set of planning activities that will lay the groundwork for a scientific project aimed at integrating complementary theories and methods to 1) develop, validate, and apply cutting-edge tools and methods for minimally invasive, multi-dimensional, high-resolution measurement of behavior at the level of the organism, with synchronous capture of changes in the organism’s social or physical environment; and 2) develop data science and computational methods that allow for integration of multidimensional behavioral and environmental data representing multiple timescales, and that will establish of a conceptual and/or computational model of behavior as a complex dynamic system. Prospective projects are expected to be designed with the potential to integrate synchronously recorded neural data and/or inform existing models of neurobehavioral function, such as those developed with the support of the NIH BRAIN Initiative. The purpose of this R34 planning grant opportunity is to support planning and development of the research framework, design, and approach, including activities that will establish feasibility, validity, and/or other technically qualifying results that, if successful, would support a competitive application for a U01, or equivalent, NIH research award.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.

Key Dates

Posted Date
November 27, 2023
Open Date (Earliest Submission Date)
January 15, 2024
Letter of Intent Due Date(s)

January 15 , 2024

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
February 15, 2024 Not Applicable Not Applicable May 2024 August 2024 October 2024

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.

Expiration Date
February 16, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Conformance to all requirements (both in the 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of 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 notices 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 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 are encouraged to visit https://braininitiative.nih.gov/research/dissemination for information on opportunities for small businesses. 

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 and resource 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. Information on BRAIN BBQS Funding Opportunities can be found at the BRAIN Initiative Notices of Funding Opportunities webpage (select “BBQS” in the Filter column) or by contacting BBQS at BRAINBBQS@od.nih.gov.

BBQS Transformative and Integrative Models of Behavior at the Organismal Level

Behavior, i.e., how organisms, including humans, interact with their environments, is a critical determinant of health and a 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 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/their 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 funding opportunity is to support planning and related activities that serve to develop a basic science research project that will be the basis of a competitive application for a U01 or similar NIH research award designed to address the following major objectives:

  1. Building an interdisciplinary, functionally diverse team including scientists and engineers with diverse life experiences and from diverse fields including, but not limited to, neuroethology, evolutionary biology, neurobiology, behavioral ecology, anthropology, the social sciences, cognitive neuroscience, neurocognitive development, biomechanics, bioengineering, human factors, 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 as an integrated organismal system allowing animals, including humans, to interact with their social and/or physical environments. Research designs are expected to include minimally invasive, minimally intrusive, synchronous collection of environmental and behavioral data from individuals. Analysis across multiple timescales is strongly encouraged.
  3. Establishing the framework for a testable conceptual and/or predictive or testable statistical/computational model (including machine learning (ML)/artificial intelligence (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.

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 or similar NIH research award. Applications are not required to include preliminary data. 

This R34 RFA is intended to stimulate fundamental basic research in a variety of animal models and humans; and while such research may generate insights relevant to neurobehavioral disorders, this RFA is not intended to stimulate research that is specifically disease related. NIH defines basic research consistent with the definition of basic research in federal code, “the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind.” (32 CFR 272.3). 

Additional information relevant to the planning of research involving human subjects

This R34 can be used to support research activities that fall within the NIH definition of a clinical trial and are aimed specifically at developing basic research as described above. Research utilizing experimental manipulations and assessment of biomedical and behavioral outcomes in healthy human subjects and those diagnosed with disorders would be considered responsive to this R34 NOFO only if the purpose of the activities and planned research is the elucidation of mechanisms or fundamental principles underlying behavior. This R34 is not intended to support planning or other activities leading to a clinical research project aimed at assessing the safety, efficacy, or impact of an intervention or manipulation on the health status of participants. 

In the design of studies that will involve human subjects or the use of human subject data, the analytic and ethical challenges of collecting, archiving and analysis of individual-level participant data are to be considered. Applications proposing research involving humans or data collected from human subjects will be required to include an ethicist on the investigator team. Applicants planning to include human subjects research or data from humans are strongly encouraged to consult the Scientific/Research Contact listed in Section VII.  

Plan for Enhancing Diverse Perspectives

  • This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310, submitted as Other Project Information as an attachment (see Section IV). 
  • Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. 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.

Planning activities of interest may develop research with the following representative, but not exhaustive, objectives:

  • Development, novel application, or adaptation of hardware and/or software tools that advance innovative methods to simultaneously capture and quantify multiple dimensions of behavior including, but not limited to, ambulation; body, limb, head, facial and/or eye movements; changes in respiration and sniffing; vocalizations, speech, gestures or other modalities of communication; peripheral physiology and glandular secretions; and blood markers obtained with minimally-invasive methods
  • Modification of sensing technologies, including changes in form, sensitivity, reliability and durability, in order to 
    • Improve capture and quantification of homologous or analogous behavioral processes across species or in an individual across development
    • Improve reliability and validity with respect to measuring a given behavior across different environments and/or across time in dynamic environments
    • Significantly reduce the intrusiveness or burden of the sensing method on the subject 
    • Improve temporal resolution and sampling duration, data quality and/or data storage capacity
  • 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 subject) for the purpose of synchronous collection and integration of environmental 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 data from processes occurring across a wide range of timescales
  • Development of novel 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 subject’s response to environmental change, and that can detect relationships across a range of timescales (e.g., milliseconds to days) within and across data types
  • 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
  • Development of approaches that integrate synchronously collected neural data with multidimensional behavioral and/or environmental data

Applications Not Responsive to this NOFO

The following will be deemed “not responsive” and will be returned without review:

  • Studies measuring behavior solely as a proxy for an internal cognitive or affective process
  • Studies exclusively measuring neural activity or in which behavior is measured solely as an output of the nervous system
  • Studies in which movement and/or other behavior of the subject is highly restricted (e.g., head-fixed or chair-restrained preparations) or behavioral measures consist 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 the behavior and environment as an interactive system
  • Studies aimed at modeling a neurobehavioral disorder or disease
  • Applications in which the proposed activities or planned project involve human subjects or use of data from humans that lack expertise on ethics on the team of investigators or fail to address potential ethical considerations of the planned research
  • Applications lacking the required one-page PEDP plan
     

Prior Consultation with IC staff

Applicants are strongly encouraged to consult the Scientific/Research Contact listed in Section VII to discuss the alignment of their proposed work with the goals of this NOFO and the BRAIN Initiative Program.

Resource Sharing

If resources are expected to be produced, the application is expected to include a resource sharing plan that outlines how deliverables from the proposed activities, except data, will be shared and disseminated. Awardees will be expected to participate 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

NIDA applicants are strongly encouraged to review the guidelines and adhere to the requirements applicable to their research listed in the Special Considerations for NIDA Funding Opportunities and Awards. Upon award, these considerations will be included in the Notice of Grant Award.

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

Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

The NIH BRAIN Initiative intends to commit an estimated total of $2.2M to fund an estimated six awards.

Award Budget

Application budgets should reflect the actual needs of the proposed project. The combined budget for direct costs for the two-year project period may not exceed $450,000. No more than $225,000 may be requested in any single year.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is two years.

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

Eligible Organizations

All organizations administering an eligible parent award may apply for a supplement under this NOFO.

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 (Organizations)
Foreign Organizations

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

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

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

Required Registrations

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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information. 

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

Eligible Individuals (Program Director/Principal Investigator)

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 Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the 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: NIDALetterofIntent@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

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 recruitment and participation of investigators from diverse backgrounds, including 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.  

SF424(R&R) Senior/Key Person Profile

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, with the following additional instructions.

PEDP implementation costs

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy

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 planned project must address the following major objectives:
    1. Building an interdisciplinary, functionally diverse, team including scientists and engineers with diverse life experiences and perspectives, and from diverse fields including, but not limited to, neuroethology, evolutionary biology, neurobiology, behavioral ecology, anthropology, the social sciences, cognitive neuroscience, neurocognitive development, biomechanics, bioengineering, human factors, 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 in organisms, including humans, interacting with their social and/or physical environments, more specifically,
      • Methods and tools for synchronous, high-temporal-resolution measurement of multiple modalities of behavior including, but not limited to, body, limb, facial and eye movements; ambulation; vocalization, speech, gestures and other modalities of communication; sniffing; and coordinated autonomic and peripheral physiological changes (e.g., glandular secretion; changes in heart rate, respiration, blood insulin or glucose levels). The proposed approaches should allow for natural, minimally impeded expression of behavior or represent significant advances towards minimizing constraints on behavior and leveraging natural behavior in research paradigms involving synchronous collection of neural and behavioral data. 
      • Measurement of multiple 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 that signal threat; and/ or other discreet stimuli or continuous changes in the environment (e.g., temperature, lighting, social and non-social sounds, olfactory signals) of biological relevance to the organism. The approach should include synchronous collection of environmental and behavioral data and may include collection of environmental data across multiple timescales that may inform the behavior of the organism.
    3. Establishing the framework for a testable conceptual and/or predictive or testable statistical/computational model (including machine learning (ML)/artificial intelligence (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.
  •  The planning and research activities must be informed by multiple behavioral science frameworks or approaches from fields such as those suggested in Major Objective 1, above. Use of developmental frameworks and/or comparative approaches is encouraged. The application should also 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 at the level of the organism.
  • The applicant must indicate how the proposed R34 activities will lay the groundwork for a future Team 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 U01 or similar application.
  • Applications must include milestones for each of the above required major objectives; specifically, milestones tracking design and development of a full-scale (Team U01 or similar) project with the above required research objectives. Including the development of quality assurance procedures, e.g., for data collection, annotation and analysis, is strongly encouraged. 
  • Although planned projects are not required to include neural activity data, software tools and computational models generated as part of the planned research must be designed with the potential to integrate neural data captured synchronously with behavioral data in freely moving animals or human subjects.
  • The plan must consider 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 must be transdisciplinary, with scientists and engineers from diverse fields including, but not limited to, those suggested in Major Objective 1, above.  Team members should bring diverse perspectives and expertise to observing, measuring, and modeling behavior.
    • The team must include substantial expertise in neuroscience and computational modeling.
  • If the planned project will involve human subjects or data from humans, the following are also required:
    • The team must include an ethicist with appropriate expertise to address potential ethical challenges and considerations relevant to the proposed research.
    • The plan must consider the analytic and ethical challenges of collecting, archiving and analysis of subject-level data, including but not limited to the potential impact of the sensing methods or artificial intelligence-based tools to be developed, and considerations of privacy, bias, influence and ownership in the collection and use of 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 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, with the following modifications. 

If resources are expected to be produced as part of the activities supported by this R34 award, a resource sharing plan should be included that meets expectations of the BRAIN Initiative. The Resource Sharing Plan should outline how the deliverables from the proposed project, except for data, will be shared and disseminated. Resources to address in the Resource Sharing Plan include algorithms, formal theories, models, methods/protocols, software, technology, etc.). Awardees will be expected to participate in post-award activities (e.g., BRAIN Initiative investigator meetings) designed to increase sharing of resources, data, protocols, and other information. 

Other Plan(s):

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

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

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

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

Appendix:

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

Foreign Organizations

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the 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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the 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 NIDA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications must include annual milestones. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. 

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. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this RFA, 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 Team Science U01 or similar NIH award. The impact of these R34 applications will be reviewed on the following bases:

  1. The potential impact of the planned (i.e., future U01-supported) research project, if successful, with respect to the goal of BBQS Transformative and Integrative Models of Behavior at the Organismal Level, as described in Section I of this NOFO.
  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 award, or equivalent.

Applicants are not expected to propose fully powered experiments or the 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 aimed directly at elucidating mechanisms underlying specific diseases or developing or testing therapeutic interventions. 

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 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?

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:

  • To what degree do the planning activities supported by the R34 lay the groundwork for a project that will address the three 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 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?

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 is the overall quality of the proposed planning project impacted by the functional diversity of the team, i.e., diversity among team members with respect to life and professional experiences; scientific expertise and theoretical perspective; expertise in specific approaches; 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 from humans will be included in the planned project, does the team include an ethicist with the expertise to identify and address potential ethical challenges relevant to the proposed research objectives and activities, and prospective use of data?
  • 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?

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:

  • 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 modeling 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 do the planning activities include innovative approaches for integrating perspectives from multiple disciplines or enhancing team science?
  • 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?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

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 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 U01 (or project of similar scale) relevant to the major objectives described in Section IV?  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 U01 or similar application? 
  • How well-developed are the milestones and timeline of the planning activities?
  • To what degree will the planned activities lead to 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 proposed methodology or technology on the organism’s behavior? Will the planned approaches lead to less intrusive methods for capturing behavior than are currently widely available?
  • 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? 
  • How well-developed are plans for analysis of multimodal and multi-timescale data?
  • How rigorous and/or quantifiable are the proposed criteria for validation? 
  • If the planned project will involve human subjects or data from humans, how well do the planning activities consider ethical issues relevant to the project, including but not limited to the potential impact of the sensing methods or artificial intelligence-based tools to be developed, and considerations of privacy, bias, influence and ownership in the collection and use of 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?

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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. 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

Additional Review Considerations

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 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 NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the NIH BRAIN Initiative, the BRAIN Initiative Multi-Council Working Group, and, as appropriate, national Advisory Councils of participating Institutes. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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:

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.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website

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

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 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.”

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

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 regular 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.

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.

  • Awardees will provide updates at least annually on implementation of the PEDP

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 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – 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.

Application Submission Contacts

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

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

Scientific/Research Contact(s)

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

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Ericka Wells
National Institute on Drug Abuse (NIDA)
Phone: 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.

Authority and Regulations

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

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