BRAIN Initiative: Theories, Models and Methods for Analysis of Complex Data from the Brain (R01 Clinical Trial Not Allowed) is sponsored by National Institute on Drug Abuse (NIDA) / NIH. An R01 research project grant under the BRAIN Initiative targeting development of theories, models, and methods for analyzing complex brain data; clinical trials are not allowed.

RFA-DA-27-004: BRAIN Initiative: Theories, Models and Methods for Analysis of Complex Data from the Brain (R01 Clinical Trial Not Allowed) 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 ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and National Center for Complementary and Integrative Health ( NCCIH ) Funding Opportunity Title BRAIN Initiative: Theories, Models and Methods for Analysis of Complex Data from the Brain (R01 Clinical Trial Not Allowed) R01 Research Project Grant April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 . 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 See Part 2 Section III.

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

279, 93. 372, 93. 242, 93.

865, 93. 286, 93. 273, 93.

867, 93. 866, 93. 173, 93.

213, 93. 853 Funding Opportunity Purpose This notice of funding opportunity (NOFO) seeks applications to develop theories, models and methods (TMM) as tools that will advance a quantitative and predictive understanding of brain function across multiple scales, including behavior.

Priority will be given to projects that develop novel capabilities for analyzing, integrating, and interpreting the large-scale, complex data emerging from the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative and related efforts, which includes cell-type specific physiological, anatomical, connectivity, and behavioral data.

Proposed experimental work must be limited to model parameter estimation and/or testing the validity of the tools being delivered. It is expected that the TMM tools developed under this NOFO will be made widely available to the neuroscience research community for their use and modification.

Funding Opportunity Goal(s) To provide extramural research support for the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative ’s aim of revolutionizing our understanding of the brain and its function in unprecedented detail.

The NIH BRAIN Initiative’s focus is foundational development of new technologies and tools to map, monitor, and modulate brain circuits in model systems and humans – toward the ultimate goal of treating and curing human brain disorders.

Open Date (Earliest Submission 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.

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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Workspace to prepare and submit your application and eRA Commons to track your application. 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 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, the National Institutes of Health (NIH)'s contributions to the BRAIN Initiative were initially guided by " BRAIN 2025: A Scientific Vision ," a strategic plan that detailed seven high-priority research areas .

This plan was updated and enhanced in 2019 by: " The BRAIN Initiative 2. 0: From Cells to Circuits, Toward Cures " and " The BRAIN Initiative and Neuroethics: Enabling and Enhancing Neuroscience Advances for Society ."

This, and other BRAIN Initiative notice of funding opportunities (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 and Neuroethics Working Group . The NIH BRAIN Initiative recognizes innovative ideas that require creativity, broad scientific expertise and experience.

There are many benefits that flow from a scientific workforce with broad participation including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, and enhancing public trust. The NIH also encourages businesses to participate in the BRAIN Initiative.

It is possible for companies to submit applications directly to BRAIN Initiative program announcements or to collaborate with academic researchers in joint submissions. Small businesses should consider applying to one of the BRAIN Initiative small business NOFOs . The BRAIN Initiative requires a high level of coordination and sharing between investigators.

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

RESEARCH OBJECTIVES AND SCOPE The Theories, Models and Methods (TMM) program provides support for the development and validation of innovative and rigorous theories, models and methods as tools that will advance a quantitative and predictive understanding of brain function across multiple scales, including behavior.

Priority will be given to projects that develop novel capabilities for analyzing, integrating, and interpreting the large-scale, complex data emerging from the BRAIN initiative and related efforts, which includes cell-type specific physiological, anatomical, connectivity, and behavioral data.

Applications to this NOFO should focus on the development of fundamentally new or significantly advanced theories of brain function; mechanistic and/or predictive models of neural circuit activity and behavior grounded in empirical data; and/or novel computational or statistical methods for analyzing neural and behavioral datasets.

TMM tools for analyzing brain activity must leverage data with cellular and sub-second temporal resolution (e.g., single-unit recordings, cellular imaging, connectomics) OR must integrate information across multiple, clearly defined temporal scales (e.g., from synaptic events to learning) .

Approaches relying solely on non-invasive, low-resolution signals (e.g., scalp EEG, fMRI BOLD) must be directly integrated with and constrained by cellular/circuit-level data . TMM tools for analyzing behavior must incorporate neural data AND must span multiple relevant temporal scales , capturing dynamics pertinent to the neural processes and behavior under investigation.

Proposed experimental work must be limited to model parameter estimation and/or testing the validity of the TMM tools being delivered. It is expected that the TMM tools developed under this NOFO will be made widely available to the neuroscience research community for their use and modification. TMM projects are required to collaborate with a cohort of end users to provide user feedback.

Specific topics of interest include, but are not limited to: Theories of brain function Development of predictive, mathematically-grounded theories explaining how behavior arises from neural structure, circuit dynamics, computation, cognition, and environmental variables.

Examples include: Theories of embodied computation that anchor the neural representation of sensory, cognitive, and motor variables to an individual/animal’s ongoing interactions with the environment through dynamic, moment-to-moment, circular, and iterative processes.

Theories that bridge multiple scales of spatial organization (e.g., molecular, synaptic, cellular, circuit, systems) and/or temporal dynamics (e.g., milliseconds to lifetimes) to generate testable predictions of brain-behavior links or cognitive function.

Theories linking circuit dynamics and function to specific properties of cell types or anatomical connections, identifying general rules, scaling principles, and contributions of specific circuit motifs to computation.

Theories elucidating fundamental computational principles employed by biological neural networks, potentially drawing inspiration from or contrasting with artificial networks, but firmly grounded in biological constraints (e.g., neuronal/synaptic dynamics, connectivity patterns, metabolic limits, specific cell-type properties, learning rules).

Computational models of neural and behavioral dynamics Development and validation of quantitative models that are mechanistically grounded, interpretable, predictive, and rigorously tested against neural and behavioral data. Examples include: Mechanistic, interpretable, and/or predictive models of neural dynamics, circuit function, or brain-behavior links that integrate biological details with computational principles.

Models that integrate knowledge across multiple levels (e.g., linking behavior to neural population activity and cellular/circuit properties).

Models of cognitive processing (e.g., sensory coding, decision-making, motor control, learning, memory) that are mechanistically grounded in identified circuit elements and dynamics, make quantitative predictions, and are rigorously tested against neural and behavioral data, potentially under ecologically relevant or challenging conditions (e.g., limited information, dynamic environments).

Development and analysis of neural-inspired computational architectures or artificial intelligence/machine learning systems explicitly designed to gain novel insights into brain function. Methods for complex data analysis Development of novel computational, statistical, and analytical techniques designed to extract key insights from complex, large-scale neuroscience datasets.

Examples include: Development of innovative and scalable computational/statistical methods for dimensionality reduction, identifying latent structure, disentangling contributing factors (e.g., sensory, motor, cognitive, state variables), extracting key dynamical features, or characterizing information flow within large, complex neural and behavioral datasets.

Novel approaches for principled data fusion and assimilation to quantitatively integrate heterogeneous datasets (e.g., linking behavior with multi-regional activity, anatomical connectivity, and cell-type information) to infer new theories of brain function, or to constrain and validate multi-scale computational models.

Novel statistical/signal processing methods (e.g., component analysis, graphical models, compressed sensing) to track structure in neural data and link to biophysical signals for mechanistic insights across scales. Applications Not Responsive to this NOFO Applications deemed to be non-responsive will not proceed to review.

The following are considered non-responsive for this NOFO: TMM tools for analyzing brain activity that do not leverage data with cellular and sub-second temporal resolution OR that do not explicitly aim to integrate information across multiple, clearly defined temporal scales. TMM tools relying solely on non-invasive, low-resolution signals that are not directly integrated with cellular/circuit-level data.

TMM tools for analyzing behavior that do not incorporate neural data AND that do not span multiple relevant temporal scales. TMM tool development that is not clearly aimed at elucidating or predicting neurobiological mechanisms. Proposed experimental work other than model parameter estimation and/or validity testing of the TMM tools being delivered.

TMM tools, using disease or treatment paradigms, that are not used to understand underlying behavioral and functional brain circuits. National Institute on Drug Abuse (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. 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 required 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).

See Section IV. 2 – Resource Sharing Plan , below. 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 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 The OER Glossary and the How to Apply Application Guide provide 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 number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. The NIH BRAIN initiative anticipates providing $6M per year to fund up to 15 awards each year.

Application budgets are not limited, but are expected to range between $150,000 to $350,000 direct costs per year. Investigators are expected to request a budget that is required to accomplish the proposed work. Awards are for three years of support.

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 Higher Education Institutions - Includes all types 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 (Foreign Organizations) Foreign Organizations/ International Collaborations NIH will no longer issue awards (new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025. Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors. 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 the 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 registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. 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 Guid e must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guid e must be followed. All instructions in the How to Apply- Application Guide must be followed. The budget should include funds necessary for travel for up to two key personnel to participate in the BRAIN Initiative Biennial Conference.

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 Guid e must be followed.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: MAJOR RESEARCH OBJECTIVES AND SCOPE Applications to this NOFO should focus on the development of fundamentally new or significantly advanced theories of brain function; mechanistic and/or predictive models of neural circuit activity and behavior grounded in empirical data; and/or novel computational or statistical methods for analyzing neural and behavioral datasets.

TMM tools for analyzing brain activity must leverage data with cellular and sub-second temporal resolution (e.g., single-unit recordings, cellular imaging, connectomics) OR must integrate information across multiple, clearly defined temporal scales (e.g., from synaptic events to learning).

Approaches relying solely on non-invasive, low-resolution signals (e.g., scalp EEG, fMRI BOLD) must be directly integrated with and constrained by cellular/circuit-level data . TMM tools for analyzing behavior must incorporate neural data AND must span multiple relevant temporal scales , capturing dynamics pertinent to the neural processes and behavior under investigation.

Proposed experimental work must be limited to model parameter estimation and/or testing the validity of the TMM tools being delivered . It is expected that the TMM tools developed under this NOFO will be made widely available to the neuroscience research community for their use and modification. TMM projects are required to collaborate with a cohort of end users to provide user feedback.

Applicants are required to explicitly state the use case for their proposed analytical tool and describe how it can be generalized to other behavior and/or functional circuits in the brain.

The proposed activity must have a clear statement of how the tool could be widely used by the neuroscience community and influence fundamental approaches to understanding neuroscience data with cellular and sub-second temporal resolution OR multiple temporal scales.

This statement should clearly articulate the specific theoretical or technical challenge that is being addressed and describe how the proposed tool would assist in understanding underlying neurobiological mechanisms.

It is expected that projects will require a collaboration of theorists, modelers, data scientists, experimentalists, and end users to develop new analytical tools (including theoretical frameworks, modeling platforms and analysis algorithms) for understanding specific challenges and problems. For each discipline, the roles and contributions of each expert must be explicitly stated and clearly delineated.

While experimental data collection under this NOFO must be limited to model parameter estimation and/or validity testing, collaboration with experimentalists is strongly encouraged. It is expected that the end deliverables will be used to inform experimental paradigms, hypotheses, and/or data collection.

All applicants are required to outline strategies and metrics for the collaborating end user(s) to evaluate the credibility of the proposed theories, models and methods; applicants must also describe how these analytical tools will address the question(s) of interest within the intended domain.

Examples of strategies and metrics include: comparing proposed theories with other existing theories; performing verification, validation, uncertainty quantification, sensitivity analysis, and documenting limitations of the proposed models and methods.

Under circumstances where it may be impractical to perform verification, validation, uncertainty quantification and/or sensitivity analysis of the proposed analytical tools, applicants are required to substantiate: (1) why it is impractical; and (2) where appropriate, propose alternative methods and metrics that can help build confidence in the analytical tool and/or their predictive capabilities for the intended domain of use.

Applicants should provide a timeline and personnel effort needed for end user evaluation. The end deliverables for the proposed theories, models or methods should be clearly defined and quantifiable. Applicants should describe the source of the existing data used (e.g., from other investigators, BRAIN Initiative Data Archives, PhysioNet.

org, Datadryad. org, CRCNS. org, NIF, NITRC, IEEG, etc.) to develop the proposed analytical tool.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide . All applications, regardless of the amount of direct costs requested for any one year, must address a plan for sharing the analytical tools (e.g., theories, models and methods) produced from the proposed project.

The plans may include policies for access and sharing; including provisions for appropriate protection of privacy, confidentiality, security, intellectual property, or other rights or requirements. Resource Sharing Plans for all TMM tools developed under this NOFO must include a section beginning with the heading " Tool Sharing Plan ."

This plan should provide details for the tool components or modules, tool parameters and associated datasets. The plan should include the minimum requirements for tool documentation, tool building, tool validation and tool reproducibility. Applicants are also expected to include plans to link proposed tools with other relevant tools.

Resource Sharing Plans for TMM tools that include software to instantiate the proposed mathematical or statistical theories, models and methods must also include a section beginning with the heading " Software Sharing Plan. " There is no prescribed single license for software produced through grants responding to this announcement.

This NOFO, however, includes goals for software dissemination, and requires applicants to include plans for software dissemination plans relative to these goals: The software should be freely available to biomedical, biological, behavioral, environmental, and clinical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.

The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages. To preserve utility to the community, the software should be transferable such that another individual or team can reproduce the analytical tool and continue development if the original investigators are unwilling or unable to do so.

The terms of software availability should include the ability of researchers to modify the source code and to share modifications with other colleagues. In support of this goal, awardees are encouraged to manage and disseminate their source code through an open revision control and source code management system.

An applicant should take responsibility for creating the original and subsequent official versions of a piece of software, and should provide a plan to manage the dissemination or adoption of improvements or customizations of that software by others. This plan should include a method to distribute other user's contributions such as extensions, compatible modules, or plug-ins.

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. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

Additionally, in accordance with the Notice of Data Sharing Policy for the BRAIN Initiative ( NOT-MH-19-010 ), recipients of BRAIN Initiative awards will be required to share the data they collect using the BRAIN Initiative informatics infrastructure (both data archives and relevant data standards), consistent with authorities under the 21st Century Cures Act and these awards authorized under that Act.

All applications to BRAIN Initiative NOFOs must include a Data Management and Sharing Plan. Recipients will be required to coordinate with Program Staff to select appropriate BRAIN Initiative data archives and to submit data to the selected archives every 6 months of the award period. Submitting data to an archive is distinct from sharing that data with the research community.

Submitted data will be held in a private enclave until the data are shared with the research community. After the data have been submitted to the appropriate data archive, it will be shared with the research community when papers using the data have been published or at the end of the award period, whichever occurs sooner.

Consistent with authorities under the 21st Century Cures Act, all applications to BRAIN Initiative NOFOs must include a Data Management and Sharing Plan.

The BRAIN Initiative data sharing policy ( NOT-MH-19-010 ) establishes the expectation that this plan should include: A summary of the data that will be shared; A description of the standard(s) that will be used to describe the data; The archive(s) that will house the data; and The proposed timelines for submitting data to the archive and for sharing data with the research community.

An updated listing of BRAIN Initiative archives is provided at the BRAIN Informatics website. Currently, established archives that may be relevant to this funding opportunity include, but are not limited to: Distributed Archives for Neurophysiology Data Integration (DANDI; https://www. dandiarchive.

org ; R24MH117295) for cellular neurophysiology data; The Neuroscience Multi-omic Data Archive (NeMO; https://nemoarchive. org/about ; R24MH114788) for data from -omics experiments; The Brain Image Library (BIL; https://www. brainimagelibrary.

org ; R24MH114793) for confocal microscopy data; Data Archive for the BRAIN Initiative (DABI; https://dabi. loni. usc.

edu ; R24MH114796) for data related to human invasive device research; OpenNeuro ( https://openneuro. org ; R24MH117179) for magnetic resonance imaging and