BRAIN Initiative: Targeted BRAIN Circuit Dysfunction and Repair (R01 Clinical Trial Optional)

BRAIN Initiative: Targeted BRAIN Circuit Dysfunction and Repair (R01 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH) - National Institute of Neurological Disorders and Stroke (NINDS). This FOA supports research that aims to understand and develop interventions for circuit-specific dysfunction in neurological and neuropsychiatric disorders.

Research may include advanced neural recording, stimulation, and manipulation techniques, which aligns with Dr.

Expired RFA-NS-21-013: BRAIN Initiative: Targeted BRAIN Circuits Projects- TargetedBCP (R01 Clinical Trial Not Allowed) This notice has expired. 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 of Neurological Disorders and 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 Mental Health ( NIMH ) National Center for Complementary and Integrative Health ( NCCIH ) National Institute on Aging ( NIA ) Office of Behavioral and Social Sciences Research ( OBSSR ) Office of Research on Women's Health ( ORWH ) This FOA is being funded by the NIH BRAIN Initiative .

Funding Opportunity Title BRAIN Initiative: Targeted BRAIN Circuits Projects- TargetedBCP (R01 Clinical Trial Not Allowed) R01 Research Project Grant February 10, 2022 - BRAIN Initiative: Targeted BRAIN Circuits Projects- TargetedBCP (R01 Clinical Trial Not Allowed). See Notice RFA-NS-22-026 . August 28, 2021 - Notice of Participation of the National Institute on Aging (NIA) in RFA-NS-21-013.

See Notice NOT-AG-21-059 . Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) 93. 853, 93.

242, 93. 279, 93. 865, 93.

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

286, 93. 173, 93. 313, 93.

866 Funding Opportunity Purpose This FOA solicits applications for research projects that seek to understand how circuit activity gives rise to mental experience and behavior using innovative, methodologically-integrated approaches. The goal is to support adventurous projects that can realize a potentially transformative outcome within 5 years.

Applications are expected to address circuit function in the context of specific behaviors or neural systems, such as sensation, perception, attention, reasoning, intention, decision-making, emotion, navigation, communication, or homeostasis. Projects should link theory, data analysis, and/or computational approaches to experimental design and should produce predictive models (conceptual or quantitative).

Projects should aim to improve the understanding of circuits of the central nervous system by systematically controlling stimuli and/or behavior while actively recording and/or manipulating dynamic patterns of neural activity.

Diverse species or experimental systems and a cross-species/comparative approach are welcome and should be chosen based on their power to address the specific question at hand and to reveal generalizable and fundamental neuroscience principles.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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 SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

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.

Funding Opportunity Description The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is aimed at revolutionizing our understanding of the human brain.

By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, will show how individual cells and complex neural circuits interact in both time and space. It is expected that the application of these new tools and technologies will ultimately lead to new ways to treat, cure, and even prevent brain disorders.

NIH is one of several federal agencies involved in the BRAIN Initiative. Planning for the NIH component of the BRAIN initiative is guided by the long-term scientific plan, BRAIN 2025: A Scientific Vision , which details seven high-priority research areas and calls for a sustained federal commitment of $4. 5 billion over 12 years.

This report can be found at http://braininitiative. nih. gov/ .

This Funding Opportunity Announcement (FOA) and other FOAs issued in Fiscal Year 2020 are based on careful consideration by the NIH of the recommendations of the BRAIN 2025 Report, and input from advisory councils supported by the NIH BRAIN Multi-Council Working Group. Videocasts of the NIH BRAIN Multi-council Working Group are available at http://www. braininitiative.

nih. gov/about/mcwg. htm .

In addition to the National BRAIN initiative, the NIH continues to have a substantial annual investment in neuroscience research. The Institutes and Centers contributing to the NIH BRAIN Initiative support those research efforts through investigator-initiated applications as well as through specific FOAs.

Potential applicants to this FOA are strongly encouraged to contact Scientific/Program staff if they have any questions about the best FOA for their research.

To enable rapid progress in development of new technologies as well as in theory and data analysis, the BRAIN Initiative encourages collaborations between neurobiologists and scientists from statistics, physics, mathematics, engineering, and computer and information sciences; and NIH welcomes applications from investigators in these disciplines.

Consistent with NOT-OD-20-031 , NIH encourages BRAIN Initiative applications from institutions supporting research by investigators who are underrepresented in the biomedical, behavioral, or clinical research workforce (see data at http://www. nsf. gov/statistics/showpub.

cfm? TopID=2&SubID=27 , the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering, and NOT-OD-20-031 ). This FOA is related to the Recommendations in Section III.

2, 3, 4, 5 and 7 of the Final Report ( http://www. nih. gov/science/brain/2025/index.

htm ) of the BRAIN working group to the NIH Advisory Committee to the Director (ACD) , which was endorsed by the ACD on June 5th, 2014 .

Specifically, this FOA solicits applications that will address the recommendations on Maps at Multiple Scales , "The Brain in Action", "Demonstrating Causality", "Identifying Fundamental Principles" and From BRAIN Initiative to the Brain (Section III Implementation: Goals, Deliverables, Timelines and Costs, Parts 2 3, 4, 5 and 7) of the Final Report.

All FOAs in this family of initiatives emphasize the use of cutting-edge methods of activation and recording to understand the behavior of circuits at cellular and sub-second levels of spatial and temporal resolution; that is, at the level of the dynamic, functional units of circuits. All FOAs welcome basic research.

The primary goal of this FOA is to solicit research projects that seek to understand how circuit activity gives rise to mental experience and behavior using innovative, methodologically-integrated approaches.

Applicants should seek to demonstrate how new and advanced experimental capabilities, integrated methodology, and multidisciplinary expertise can be used to transform the general understanding of neural information processing within the context of specific systems or circuits. This FOA instructs applicants and reviewers that projects more adventurous and innovative than traditional NIH applications are encouraged.

Experimental goals should focus on questions of fundamental neurobiology that informs how the normal nervous system works, and can include natural and experimental perturbations that provide mechanistic tests about circuit functions. Projects must include a quantifiable behavior, or behavior of a well-defined neural system.

Approaches must offer to identify, record, and/or manipulate identified circuits involved in the behavior with sufficient coverage to capture circuit level dynamics and mechanisms beyond individual cells or synapses. Model-driven experimental design and/or computational approaches should be used to frame mechanistic questions about circuit functions.

Results must include a predictive model at a computational or conceptual level of understanding. Multi-scale approaches, from biophysics to social contexts, are encouraged to enable an understanding of mechanisms at the meso-scale, circuit level.

Diverse species or experimental systems and a cross-species/comparative approach are welcome and should be chosen based on their power to address the specific question at hand and to reveal generalizable and fundamental principles. Targeted BRAIN Circuit Project R01 awards will support an individual laboratory or a small multi-PD/PI team.

Supported projects will reflect the NIH BRAIN Initiative interests in the application of cutting-edge methodologies in the service of understanding central nervous system circuit function at cellular and sub-second levels of resolution in ethologically relevant behaviors of an organism or a well-defined neural system.

Applications should offer specific, feasible, and potentially transformative research goals as endpoints within a 5-year term. The list below includes representative, but not exhaustive, examples of topics that could be considered responsive to this FOA. Innovative approaches to understand network coding of sensory information in response to naturalistic inputs and perceptual contexts.

New paradigms to assess motor coding during quantifiable behaviors in real or virtual environments. Novel approaches to understand neural circuitry associated with well-defined social behaviors. Dynamic changes in functional circuit connectivity underlying the brain's ability to store information and to learn new behaviors.

Distributed circuits that contribute to the coordination of motivational states and reward behavior. New approaches to capture and assess information processing across brain regions during memory consolidation, memory retrieval, spatial/relational processing, attention, or planning.

Approaches to assess distributed representations and the information processing underlying advanced mental processes such as decision making, numerical cognition, reasoning, and metacognition. Empirical and analytical approaches to understand how behavioral states are emergent properties of the interaction of neurons, circuits, and networks. Research for mechanistic understanding of circuits that spans stages of development.

Approaches that utilize the cellular, genetic and technological methodologies developed by the NIH BRAIN Initiative. Research to advance principles of circuit function and neural systems in the central nervous system that regulate homeostasis, including biorhythms, and the balance of temperature, respiratory, energy and metabolic functions.

Innovative approaches and new paradigms for identifying and understanding nociception and pain in the context of circuit mechanisms of the central nervous system. Non-Responsiveness Criteria: Applications deemed to be non-responsive will not proceed to review.

The following are considered non-responsive to this FOA: Applications for the study of specific disease mechanisms, or specific disease therapeutics and treatments will be considered nonresponsive to this BRAIN Initiative FOA. While fundamental basic research often generates insights relevant to disorders of the nervous system, this FOA is not intended to stimulate research that is explicitly disease-related.

Studies for the investigation of specific diseases and disorders should be directed to the appropriate NIH Institutes. Studies of human neuroscience that utilize invasive neural recording are non-responsive and will be withdrawn. Invasive studies of human neuroscience should consider the BRAIN Initiative FOAs for Research Opportunities in Humans (see https://www.

braininitiative. nih. gov/).

Under this announcement, the NIH BRAIN Initiative will not accept applications that include clinical trials ( https://grants. nih. gov/grants/guide/notice-files/NOT-OD-15-015.

html ). Applications that include clinical trials ( https://grants. nih.

gov/grants/guide/notice-files/NOT-OD-15-015. html ) are considered non-responsive. Prior Consultation with IC staff Applicants are strongly encouraged to consult the Scientific/Research Contact listed below to discuss the alignment of their proposed work with the goals of this FOA and the BRAIN Initiative Program.

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

Award Information Grant: A support 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 SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

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 Issuing IC and partner components intend to commit an estimated total of $15 M to fund 20 awards.

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 FOA. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (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 Institutions) Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

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. eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.

gov registration, but 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 DUNS number and 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 his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. 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. 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 NOT-OD-11-101 ). Section IV.

Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution.

Links to apply using ASSIST or Grants. gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. 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: National Institute of Neurological Disorders and Stroke (NINDS) All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Consistent with NIH BRAIN Initiative goals, this FOA encourages applications that feature innovation, advanced thinking, and integrated and multi-disciplinary methodology that are well balanced with convincing tractability and potential impacts.

Diverse species or experimental systems and a cross-species/comparative approach are welcome and should be chosen based on their power to address the specific question at hand and to reveal generalizable and fundamental neuroscience principles.

Applications should address the following goals: Identify fundamental principles: Produce conceptual foundations about circuit dynamics and functional connectivity for understanding the biological basis of mental processes through development of new theoretical and data analysis tools. This FOA welcomes basic research.

Seek to understand circuits of the central nervous system by systematically controlling stimuli and/or behavior while actively recording and/or manipulating relevant dynamic patterns of neural activity and by measuring the resulting behaviors and/or perceptions. Link theory, data analysis, and/or computational tools to experimental design, and should produce predictive models (quantitative or conceptual).

Address mechanisms of circuit function in the context of specific neural systems, such as sensation, perception, emotion, motivation, cognition, decision-making, action, or homeostasis. A cellular resolution of recording circuit activity, at sub-second temporal resolution, is expected in order to address mechanistic understanding of circuit functions at the functional units of circuits.

Employ large-scale recording and manipulation of neural activity of specific circuits or systems. Scale of recording should be sufficient to account for the dynamic activity of the circuit or distributed ensemble of neurons under study, or to validate a specific, model-predicted outcome. This will be evaluated using species-appropriate considerations.

The resolution of mechanistic manipulation of circuits is relaxed from that of single cells to that of cell type/location specificity (e.g., compatible with focal TMS, micro-stimulation, micro-injection, optogenetics/DREADDs, targeted viral vectors). When a simple circuit is employed it should be made clear how it reveals general neuroscience principles.

Offer an innovative plan to share data and analytical algorithms with the research community to further advance research on the circuit mechanisms of the specified dynamic neural systems. Applications must apply NIH standards of experimental and publication rigor ( http://grants. nih.

gov/grants/guide/notice-files/NOT-OD-16-011. html) and must comply with NIH policy on reporting disaggregated sex-based data and other consideration of sex as a biological variable as elaborated in NOT-OD-15-102 , NOT-OD-15-103 and NOT-OD-16-031 . Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply: All applications, regardless of the amount of direct costs requested for any one year, should address a Data and Resource Sharing Plan. The BRAIN Initiative has published a guide notice in reference to data sharing ( NOT-MH-19-010 ). Data sharing plans should reflect the guidance in this notice.

The Resource Sharing Plan should outline how all the data and tool deliverables from this FOA (e.g. algorithms, theories, models, methods, software, technology, constructs, transgenic lines, etc.) will be shared and disseminated. Project-specific details will be established at the time of award. Budgets should include sufficient resources to prepare and disseminate data.

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

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

on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

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

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement , and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 1.

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

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

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

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

Errors must be corrected and a changed/corrected application must be submitted to Grants. gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E. O.

12372) This initiative is not subject to intergovernmental review. All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement .

7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide. See more tips for avoiding common errors.

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

Applications Involving the NIH Intramural Research Program The requests by NIH intramural scientists will be limited to the incremental costs required for participation.

As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs).

These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits. If selected, appropriate funding will be provided by the NIH Intramural Program.

NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

Prior Consultation with Scientific/Research Staff Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy . Any instructions provided here are in addition to the instructions in the policy. Section V.

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

For this particular announcement, note the following: The BRAIN Initiative invites fundamental basic applications that meet the goals outlined under Research Strategy and have high levels of innovation, which assumes some degree of risk. Reviewers should evaluate whether a sound rationale has been provided as to how and why the research is tractable and likely to generate an exceptionally high impact if successful.

Although reviewers will consider feasibility, they will not penalize unavoidable risks that are intrinsic to new and innovative approaches. While fundamental basic research often generates insights relevant to disorders of the nervous system, this RFA is not intended to stimulate research that is explicitly disease-related. This FOA instructs applicants and reviewers that projects more adventurous and