BRAIN Initiative: Brain Behavior Quantification and Synchronization—Next Generation Sensor Technology Development (U01) is a grant from NIH BRAIN Initiative that funds development of next-generation sensor technologies synchronized with brain recordings. The program aims to enable computational models of behavior in both humans and animals, advancing understanding of the neural basis of behavior.

Eligible applicants include universities, research institutions, nonprofits, educational institutions, government agencies, small businesses, HBCUs, and tribal colleges. Funding is provided through a cooperative agreement (U01) mechanism. Applications are due by June 2027.

RFA-MH-26-140: BRAIN Initiative: Brain Behavior Quantification and Synchronization- Next Generation Sensor Technology Development (U01 Clinical Trial Optional) 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. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Mental Health ( NIMH ) 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 on Drug Abuse ( NIDA ) National Institute of Neurological Disorders and National Center for Complementary and Integrative Health ( NCCIH ) Office of Behavioral and Social Sciences Research (OBSSR), November 20, 2024 - Participation added ( NOT-OD-25-034 ) Funding Opportunity Title BRAIN Initiative: Brain Behavior Quantification and Synchronization- Next Generation Sensor Technology Development (U01 Clinical Trial Optional) U01 Research Project – Cooperative Agreements Notices of Special Interest associated with this funding opportunity 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. November 20, 2024 - Notice of Participation of OBSSR in RFA-MH-26-140 "BRAIN Initiative: Brain Behavior Quantification and Synchronization- Next Generation Sensor Technology Development (U01 Clinical Trial Optional)". See Notice NOT-OD-25-034 .

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 Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) 93. 242, 93. 286, 93.

867, 93. 273, 93. 213, 93.

173, 93. 865, 93. 853, 93.

866 Funding Opportunity Purpose 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. 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 should consider applying to one of the BRAIN Initiative small business NOFOs . The BRAIN Initiative requires a high level of coordination and sharing among investigators. It is expected that BRAIN Initiative recipients 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 PD/PI meeting.

The data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010 . This NOFO is related to the recommendations in Priority Areas 3 and 6 of the BRAIN 2. 0 of the BRAIN working group.

Specially, this NOFO solicits applications that will address the recommendations on “The Brain in Action” and “Advance Human Neuroscience”. Development of Next Generation Sensor Technologies and Bioelectronic Devices This program capitalizes on the development of new sensor technologies that will allow synchronization with brain recordings that will allow the generation of new models of human or animal behavior.

Key aspects of sensor development include low or zero battery usage, miniaturization, and wireless configurations. For example, at nano-scale, harnessing quantum physics design principles has brought on new kinds of transistors in which fundamental limitations of their operating characteristics are now overcome and enable smaller designs.

The delivery of related nanosensors into the cellular milieu has also opened up possibilities for sensing in the cellular environment with extremely low power consumption. With the development of next generation micro-and nano-scale fabrication coupled with high-performance computing, the brain research community is ripe to develop next generation sensor designs.

Key Features for the Development of Sensors and Bioelectronics to support the BBQS research community What are the desired features of the next-generation of sensors and bioelectronics? Sensors and bioelectronic designs should include but not be limited to electrochemical, micromechanical, optical, fiber-optic, electromagnetic, radiation, temperature, inertial, acoustic and ultrasound modalities.

They may also be remote in overall design, for example with LiDAR or microwave sensing to measure position or movement. Oxygen or other gas sensors are another type of sensor to be included for monitoring of physiologic activity. Sensors need to perform with minimal or zero energy consumption, preferably with energy harvesting.

Sensors need to be next-generation with demonstration of improved performance over other previous and similar designs; the demonstration of novelty will be dependent on the particular type of sensor proposed. Justification or rationale for the proposed design will need to show that sensor performance would exhibit high reliability and repeatability in output, to ensure the most accurate measurements.

Sensors would also need to collect data in real-time, and their performance needs to be maintained over long periods, i.e. for 48 hours or longer. Combinations of multiple sensor modalities are highly encouraged to promote compact designs. There are no limitations on materials to be used in fabrication.

How will sensor data be integrated into the BRAIN Behavior Quantification and Synchronization research? In the era of micro-electromechanical systems (MEMs) and nanotechnology, and with the goals of the BBQS Program in mind, researchers need to include several features. Next generation sensing technology needs to include the acquisition of data with the highest spatial and temporal resolution possible.

Sensor data may come from within or the edge, (that is, close to where the data originates) keeping in mind the collection of only meaningful data, to minimize data storage and compute time. Sensor data in this NOFO will need to be combined with other data streams including neural recordings, either from surface or intracranial brain recordings.

Last, in the context of invasive sensing, biocompatibility and or low toxicity effects are key issues that need to be addressed. The " BRAIN 2025: A Scientific Vision " report enumerated several core principles, including that "new methods should be critically tested through iterative interaction between tool? makers and experimentalists.

After validation, mechanisms must be developed to make new tools available to all." As such, this NOFO will foster close interaction between engineers and behavioral neuroscientists, computational and data scientists in a research consortium.

The BBQS Consortium will promote rigorous sensor technology design, testing, validation, and dissemination and aid in quantification and synchronization of data to improve our understanding of behavior. The aims of the NOFO are to develop novel sensor technologies and/ or bioelectronic devices that will enrich existing sensor or other data streams to improve our understanding of human and organismal behavior.

Applicants to this NOFO should propose technologies or devices with superior performance and reliability to achieve real-time data acquisition of physiologic, physical, chemical, or electrical data. The proposed projects should demonstrate the potential to achieve as many of the following goals as possible. Applicants must address goals 1, 2, 3, 4, 5 and 6: 1.

Next-generation and compactness in design, with the expectation that this will contribute to very low or zero power consumption. Proposed sensors/devices must not consume more power than current sensors/devices. 2.

High reliability and repeatability in performance and accuracy of measurement beyond what has been previously demonstrated. 3. Sensor design with stability in battery power, and long-term performance greater than 48h, to be able to capture naturalistic behavior in real time from human or animal subjects.

4. Collection of data in real time. 5.

Biocompatibility should be high and toxic effects of sensors (either noninvasive or invasive) to cells, tissues, and organisms are quantitatively low. 6. Demonstration of synchronization of the sensor(s) data with brain recordings, including surface or intracranial recordings.

7. Intracranial recordings to be included wherever possible within the research team. 8.

Energy harvesting capability. 9. Combinations of multiple sensors or bioelectronics into a single compact design.

10. Devices that are easily produced and could be widely disseminated in the engineering and scientific community. 11.

Development of computational models of behavior using all data, including sensor data. Applicants are strongly encouraged to form multidisciplinary teams to develop a new type of sensor or bioelectronic device, using the above goals for design, fabrication, testing, validation, and dissemination. Successful applicants will become part of a research consortium (see further below) encompassing other recipients.

The NIH expects the consortium to operate as a cooperative network to promote collaboration and coordination and to achieve the program's overall goals. This will include regular meetings and other coordinated activities within the Consortium as well as in the BRAIN Initiative more broadly.

During the funding period, applicants must develop novel sensing technology or bioelectronics to be utilized in the quantification and synchronization of data, to be combined with brain recordings.

Working Together in the BBQS Research Consortium Supported U01 recipients are expected to work closely together and benefit from membership in the BBQS Consortium of researchers, including other BBQS recipients from this NOFO, and several others including from the BBQS Organismal Research Community RFA-DA-24-042 , the BBQS Human Research Community RFA-MH-26-100, the Data and Artificial Intelligence Coordination Center for the BBQS program RFA-MH-23-130 and a NOT-MH-23-115.

Coordination among Consortium members is expected to include sharing of protocols, technologies, and data to improve the optimization process of novel sensors and their integration into BBQS experimental and modeling efforts, as well as cooperation in publication and development of best practices to integrate the best technologies into the behavioral research.

To promote coordination, applications can include requests for travel funds to the Brain PI Annual Meeting.

This NOFO seeks applications in areas including, but not limited to: Design, fabrication and validation of next generation or optimized sensors including but not limited to collection of data in the following domains: MEMS, nanotechnology or nanosensor development designed to function in noninvasive, minimally invasive, or invasive applications with a plan to quantify and synchronize data for behavioral study; Combination of sensors into a single sensor design; Combination of sensor data with brain recordings, including intracranial or surface methods; Artificial intelligence or machine learning approaches for managing sensor or bioelectronics data that improve efficiency of data transmission; Use of sensor data to generate computational models of behavior; Mechanical (force, pressure, piezoelectric); Potentiometric (Solutes, Metabolites, Hormones, Neurotransmitters etc); Inertial (velocity, angular acceleration); Optical (Near-infrared (NIRS), photonic, etc.); O 2 and CO 2 blood gas sensing; Remote (Doppler radar, LiDAR etc.) sensing; Proposed Milestones and Timeline Applications must include Proposed Milestones and Timeline submitted as Other Project Information as an attachment (see Section IV).

The Proposed Milestones and Timeline should explain critical indicators of progress for Sensor and Bioelectronic device development to enhance our understanding of behavior. The Proposed Milestones and Timeline will be evaluated as part of the review process, but final versions will be agreed upon at the time of award.

If justified by scientific and/or technological needs, future year milestones may be revised, upon request, based on data and information obtained in the current year.

Non-responsive Areas of Research Applications will be considered non-responsive and will not be reviewed if they propose: Devices that are bulky, cumbersome or would need to be carried with respect to organism size and which would interfere with naturalistic behavior Devices that require hard-wired configurations for data acquisition Devices with short battery life less than 48 hours Magnetic resonance and other imaging technologies with relatively low spatial resolution Devices with low temporal resolution Sensing measurements that require invasive imaging approaches Studies primarily focused on technology development that do not propose a sensor device Applications that do not address goals 1-6 in the Research Scope section Devices that will not develop novel sensing technology or bioelectronics to be utilized in the quantification and synchronization of data, to be combined with brain recordings For projects focused on using existing tools, technology or devices to quantify and synchronize data for understanding organismal or human behavior, potential applicants should consider responding to other BRAIN Initiative NOFOs ( RFA-DA-24-042 , RFA-MH-26-100 or reissued versions).

Applicants are strongly encouraged to consult the NIMH Scientific/Research Contact listed below to discuss the alignment of their proposed work with the goals of this NOFO and BRAIN Initiative program goals. The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring ( NOT-MH-19-027 ).

The application's PHS Human Subjects and Clinical Trials Information, including the Data and Safety Monitoring Plan, should reflect the policies and guidance in this notice. Plans for the protection of research participants and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. See Section VIII.

Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II.

Award Information 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 provide details on these application types. Only those application types listed here are allowed for this NOFO.

Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NIMH and partner components intend to commit an estimated total of $10 million to fund 6-8 awards for each receipt date Application budgets are not limited but need to reflect the actual needs of the proposed project.

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 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 - Including the NIH Intramural Program 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) 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 Guide must be followed.

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. Consortium Annual In-Person Meeting Costs: Applications may include allowable costs for participating in the Consortium annual in-person meetings.

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: The following items must be addressed: Applications must describe plans for the development of next generation sensors and bioelectronics beyond their initial stages into working tools for understanding behavior in ways that are currently unachievable.

The intended outcome, by the end of this award, will be bold, high-impact, and transformative technologies to enhance our understanding of organismal and human behavior.

The specific goals to be achieved by the project must be stated in the application for the proposed project, including an explanation of how the proposed activities will serve to transform our understanding of behavior beyond what can be achieved through existing methods.

Applications must provide information regarding how their U01 application will: Advance sensors beyond the state-of-the-art, in their timing, spatial and temporal resolution capabilities, sensitivity and overall performance through the use of optimal materials and scale Build devices that will function for long recording times, that is for 48 hours and longer Optimize battery life and include considerations for energy harvesting where possible Optimize device weight to record naturalistic behavior in organism(s) or human subjects Conduct testing and validation to demonstrate improvements over existing sensor designs Adapt sensor(s) into easily produced and applied formats for behavioral neuroscience users Utilize sensors in behavioral neuroscience frameworks Combine multiple sensors in the same device where possible Integrate sensor data with neural recordings Integrate all data into computational models of behavior Consistent with NIH BRAIN Initiative goals, applications must balance innovation and advanced thinking and methodology with convincing tractability and potential impacts.

Additional Considerations for the Activities Supported by This U01 The project team must develop, generate, integrate and work towards the development of computational models of behavior and must be multi-disciplinary, including the expertise of scientists, clinicians, and engineers from fields including but not limited to: electrical engineering, bioengineering, chemical engineering, physics, materials science, computational neuroscience, neurology, neurosurgery, psychiatry, neuroethology, evolutionary biology, cognitive neuroscience, neurocognitive development, biokinetics and data science.

Team members must bring a variety of technical and scientific expertise in observing, measuring, and modeling behavior. Neural recordings must be included and may be of either surface or ideally intracranial in nature.

For projects using multiple species, describe how the sensor will be adapted to collect behavioral data If the planned project will involve human subjects or data, the plan must consider the analytical and ethical challenges of collecting, archiving and analysis of subject-level data, including privacy.

Current State-of-the-Art Statement: Investigators must specifically define the current state of technology as a benchmark against which their proposed new sensor technology performance will be measured.

A sound rationale should be provided as to why the approach proposed is the most appropriate and, if successful, likely to generate an exceptional improvement in the way sensor technology and bioelectronics development for the study of behavior is conducted in the future.

Timeline and Milestones: A timeline must be included as part of the Research Strategy and should include a distinct final section, entitled “Milestones”, that briefly proposes indicators of progress at critical junctures. These should be tailored to the unique scope of each project and details must be provided to permit a thoughtful evaluation of precisely what will be achieved throughout the duration of the project.

This should include descriptions that will indicate how the proposed approaches will be tested and validated along with alternative strategies should an effort fail to perform as expected. Investigators should describe how our current state of sensor technology, synchronization of neural data, and subsequent computational models of behavior will be transformed by the proposed project.

Animal Research/Development Inclusion: This NOFO allows animal studies that are clearly justified as necessary for the proposed development of next generation sensors and bioelectronic devices.

Applications proposing animal research before scaling up to humans must provide clear rationale as to how the findings from the proposed studies will translate up the scale and lead to the development of working tools for the study of behavior, with the intention that the technologies are capable of being used practically and ethically in healthy humans.

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 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. The data sharing expectations for BRAIN Initiative awards require that the data is deposited to relevant data archives developed by the BRAIN Initiative. Applicants can refer to NOT-MH-19-010 , for more information about BRAIN Initiative data sharing information.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide. No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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 How to Apply- 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 the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be