BRAIN Initiative: Brain-Behavior Quantification and Synchronization – Transformative and Integrative Models of Behavior at the Organismal Level (U01 Clinical Trials Not Allowed)

BRAIN Initiative: Brain-Behavior Quantification and Synchronization – Transformative and Integrative Models of Behavior at the Organismal Level (U01 Clinical Trials Not Allowed) is sponsored by National Institute on Drug Abuse (NIDA). This RFA solicits applications for next generation sensor and bioelectronic device development that will synchronize with brain recordings.

The sensor and neural recording data will be used to generate new computational models of behavior in human and animal models.

Expired RFA-DA-24-041: BRAIN Initiative: Brain-Behavior Quantification and Synchronization Transformative and Integrative Models of Behavior at the Organismal Level (U01 Clinical Trials Not Allowed) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies .

Contact the eRA Service Desk for any submission issues. Check the NIH Guide for active opportunities and notices. 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 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 ), June 6, 2024, Participation added NOT-DC-24-032 National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and 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 (U01 Clinical Trials Not Allowed) U01 Research Project – Cooperative Agreements March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 June 6, 2024 - Notice of Participation of National Institute on Deafness and Other Communication Disorders in RFA-DA-24-040 and RFA-DA-24-041.

See Notice NOT-DC-24-032 . 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) Companion Funding Opportunity Research Project (Cooperative Agreements) See Section III.

3. Additional Information on Eligibility . Assistance Listing Number(s) 93.

279, 93. 867, 93. 242, 93.

866, 93. 273, 93. 286, 93.

213, 93. 853, 93. 865, 93.

173 Funding Opportunity Purpose This Brain-Behavior Quantification and Synchronization notice of funding opportunity (NOFO) seeks applications using non-human animal models that bring together transdisciplinary teams and aim to 1) develop, validate, and apply cutting-edge tools and methods for minimally invasive, multi-dimensional, high-resolution measurement of behavior at the organismal level, with synchronous capture of data from the dynamic environment of the organism; 2) develop advanced analytic approaches to integrate multidimensional behavioral, neural and environmental data; and 3) develop and test new theoretical and computational models aiming to advance understanding of behavior as a complex dynamic system.

Proposed projects are expected to be designed with the capacity 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. This NOFO is intended for applications using non-human animal models.

Applicants proposing research involving humans or use of human subjects data as a significant component should submit under the companion NOFO RFA-DA-24-040 . Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

New Date May 24, 2025 per NOT-OD-25-113 (Originally October 10, 2026 ) 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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I.

Notice of Funding Opportunity Description This Brain-Behavior Quantification and Synchronization (BBQS) notice of funding opportunity (NOFO) seeks applications that bring together transdisciplinary teams and aim to 1) develop, validate, and apply cutting-edge tools and methods for minimally invasive, multi-dimensional, high-resolution measurement of behavior at the organismal level, with synchronous capture of data from the dynamic environment of the organism; 2) develop advanced analytic approaches to integrate multidimensional behavioral, neural and environmental data; and 3) develop and test new theoretical and computational models aiming to advance understanding of behavior as a complex dynamic system.

The proposed research is expected to be designed with the capacity to integrate synchronously recorded neural data and to incorporate neural data into new or existing models of neurobehavioral function. This NOFO is intended for applications using non-human animal models.

Applicants proposing research involving humans or use of human subjects data as a significant component will not be accepted under this NOFO and should submit under the companion NOFO RFA-DA-24-040 .

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. The NIH 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 Conference .

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

The goal of this funding opportunity is to support research with the following major objectives : To engage an interdisciplinary team including scientists from distinct fields across the behavioral and social sciences, engineers, and others with experiences and perspectives that will work to develop innovative, transdisciplinary approaches for measuring and modeling the behavior of organisms interacting with their complex, dynamic social and physical environments.

To develop or adapt sensing technology and methods that can, as non-intrusively as possible, synchronously measure multiple variables that capture behavior as a multidimensional, integrative, organismal process and simultaneously capture data from the dynamic social and/or physical environment of the organism.

Methods for monitoring behavior and physiology of the organism are expected to not constrain the behavior of animal, i.e. allow the range of movement the organism would naturally express.

To develop a predictive or testable statistical/computational model (including machine learning (ML)/artificial intelligence (AI) methods) designed to integrate multidimensional behavioral and environmental data; built with the capacity to integrate simultaneously collected neural data. Applicants must address the above three major objectives . Applications that do not explicitly address these major objectives will be withdrawn.

Research topics and activities of interest under this RFA include the following: Development, novel application and advancement of methodologies or technologies including: Hardware and/or software tools that advance novel methods to simultaneously capture and quantify multiple observable dimensions of behavior including, but not limited to, whole-body ambulation; limb, head, facial and/or eye movements; changes in respiration; speech or other vocalizations, gestures, or other modalities of communication; peripheral physiology and glandular secretions; and blood markers obtained with minimally-invasive methods.

Hardware and/or software tools for synchronous collection of dynamic environmental data (including stimuli or signals presented to and/or detectable by the subject) with behavioral data.

Analytic tools and statistical and/or computational approaches (e.g., ML/AI methods) with the capacity to integrate multidimensional behavioral and environmental data and to capture processes occurring across a wide range of timescales (e.g., milliseconds to days) within and across data types.

Use of existing data and/or synthetic data to validate or assess feasibility of sensor methodology and/or computational models based on the integration of multidimensional behavioral and environmental data Approaches that integrate multidimensional behavioral and/or environmental data with synchronous measures of neural activity.

Development and testing of new theoretical frameworks and models informed by multiple disciplines within the behavioral, neural, and social sciences, including but not limited to: New approaches for modeling the organism's physiology, behavior and environment as a complex dynamic system.

Studies examining how cognitive function (e.g. decision-making) may change as a function of the complexity of, or constraints on, the behavior of the subject, using methods that capture multiple dimensions of an integrated organismal behavioral response. Research examining evolutionary or neurodevelopmental processes influencing relationships between cognitive function and behavior at the organismal level.

Studies designed to use real-time, multimodal behavioral and environmental sensing, and computational modeling, to test potentially competing or orthogonal theories about behavioral or cognitive processes. Research examining neurocognitive and behavioral variation across individuals or within an organism as a function of the complexity of the physical or social environment.

Studies that examine how relationships between cognitive function and the complexity and kinetics of behavior at the organismal level change across neurodevelopment. Applications Not Responsive to this NOFO The following will be deemed “not responsive” and will be returned without review: Applications that include research that meets the definition of an NIH Clinical Trial.

Applications that do not address the three major objectives described above under the “ Research Objectives and Scope ” sub-section. Applications proposing exclusively studies in which behavior is highly restricted (e.g., experiments requiring head or body restraint) or in which a highly trained or stereotyped response (e.g., isolated arm or eye movement) is used solely as an assay of a cognitive process.

Research exclusively aimed at studying or modeling neurobehavioral disorders or disease. Applications with research involving human subjects or in which use of human data is a significant component.

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. A major goal of the BRAIN initiative is to support the collaborative development and dissemination of resources.

Applications are expected to provide a Resource Sharing Plan that outlines 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 required to participate in post-award activities (e.g., BRAIN Initiative investigator meetings) designed to increase sharing of resources, data, protocols, and other information. Project-specific details will be established at the time of award. Data sharing is addressed in a separate Data Management and Sharing Plan in compliance with the NIH Data Management and Sharing Policy.

See Section IV. 2 - Other Plans , below. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement.

Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI. 2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The BRAIN Initiative and its partner components intend to commit an estimated total of $8. 0M across this NOFO and its companion NOFO, RFA-DA-24-040 to fund up to ten U01 awards per year.

Application budgets are not limited but need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The maximum project period is 5 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 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 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (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. Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide . 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 Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. 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 protected] : 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. All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions.

All instructions in the How to Apply - Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Consistent with NIH BRAIN Initiative goals, applications must balance innovation and advanced thinking and methodology with convincing tractability and potential impacts.

This NOFO is intended to stimulate fundamental basic research, and while such research may generate insights relevant to neurobehavioral disorders, this NOFO is not intended to stimulate research that is specifically disease-related. Applications must address the major objectives described at the top of the “Research Objectives and Scope” subsection within Part 2. Section I.

, and reiterated below: To engage an interdisciplinary team including scientists from distinct fields across the behavioral and social sciences, engineers, and others with experiences and perspectives that will work to develop innovative, transdisciplinary approaches for measuring and modeling the behavior of organisms interacting with their complex, dynamic social and physical environments.

To develop or adapt sensing technology and methods that can, as non-intrusively as possible, synchronously measure multiple variables that capture behavior as a multidimensional, integrated organismal process and simultaneously capture data from the dynamic social and/or physical environment of the organism.

To develop a predictive or testable statistical/computational model (including machine learning (ML)/artificial intelligence (AI) methods) designed to integrate multidimensional behavioral and environmental data; built with the capacity to integrate simultaneously collected neural data. Applications must include milestones for each of the above required major objectives.

Inclusion of quality assurance procedures (e.g., for data collection, annotation and analysis) is strongly encouraged. The project team must be interdisciplinary, with scientists and engineers from fields such as neuroethology, evolutionary biology, behavioral ecology, the social sciences, cognitive neuroscience, neurocognitive development, biomechanics, and bioengineering.

The team must include substantial expertise in neuroscience and computational science. Inclusion of members from communities outside of scientific research and engineering who may increase the variety of perspectives is encouraged. Inclusion of expertise in team science is encouraged.

The rationale and approach must be informed by multiple behavioral science frameworks and approaches (e.g., cognitive neuroscience, developmental psychology, evolutionary biology, ethology, behavioral ecology, social sciences, and complex systems research). Consideration of neurobehavioral development is encouraged. The approach must include synchronous collection of behavioral and environmental data.

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; sniffing; vocalization, speech, gesturing and other modalities of communication; and coordinated autonomic and other physiological changes (e.g., glandular secretion; changes in heart rate, respiration, blood insulin or glucose levels).

Measurement of environmental changes including, but not limited to, affiliative, antagonistic, or predatory social signals; stimuli predictive of resources or threat; and other discrete or ambient changes in the environment. Analysis across multiple timescales is strongly encouraged. The application must address how the invasiveness of the proposed devices and methods, or other potential constraints on behavior, will be minimized.

Proposed approaches should leverage the behavioral repertoire of the species in naturalistic settings to the extent possible. The proposed sensing methods and computational models should be designed with the potential to integrate simultaneously collected neural data. If neural data is included, it must be integrated into a model of organismal behavior in the context of a dynamic social or physical environment.

The research strategy must include the development of a predictive or testable statistical or computational model that integrates the multidimensional data to be collected. Consideration of non-linear and complex systems modeling is encouraged.

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-as-biological-variable . Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide , with the following modifications. 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 but are not limited to algorithms, formal theories, models, methods/protocols, software, and technology. Awardees will be required to participate in post-award activities (e.g., BRAIN Initiative investigator meetings) designed to increase sharing of resources, data, protocols, and other information. Project-specific details will be established at the time of award.

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 How to Apply - Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Applicants are referred to the NIH Data Management and Sharing Policy website for guidance on developing a DMS plan. The DMS plan should align with BRAIN Initiative guidelines as outlined in NOT-MH-19-010 .

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - 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 How to Apply - Application Guide , with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply - Application Guide must be followed.

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 2.

Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4.

Submission Dates and Times Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies).

Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants. gov systems check the application against many of the application instructions upon submission.

Errors must be corrected and a changed/corrected application must be submitted to Grants. gov on or before