RFA-NS-27-015-Revised-Full-Announcement.html

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 Stroke (NINDS)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

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

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Center for Complementary and Integrative Health (NCCIH)

Funding Opportunity Title

BRAIN Initiative Connectivity across Scales (BRAIN CONNECTS): Specialized Projects for Scalable Technologies (U01 Clinical Trial Not Allowed)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of

RFA-NS-22-049

Related Notices

Funding Opportunity Number (FON)

RFA-NS-27-015

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.372, 93.853, 93.242, 93.866, 93.867, 93.173, 93.279, 93.273, 93.286, 93.213, 93.865

Funding Opportunity Purpose

This funding announcement, issued by the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative, seeks transformative, cutting-edge, and innovative research that embraces new technologies, ideas, and approaches to understand brain circuit function and contributions to behavior. It is a component of the BRAIN Initiative Connectivity Across Scales (BRAIN CONNECTS) Program, which aims to lay the scientific foundation for the next generation of neural circuit-based approaches for preventing and treating devastating brain disorders.

This Notice of Funding Opportunity (NOFO) supports Specialized Projects to develop current or emerging technologies to generate comprehensive atlases of brain connectivity, with an emphasis on human, non-human primate (NHP), and mouse. Projects using other species are also permitted, if their use is well justified and the goal is to test and validate approaches that can be generalized across species. Applications may address any aspect(s) of brain connectivity and associated data pipelines, including data collection, reconstruction, analysis, integration, dissemination, and interpretation, to enable faster, more precise, and more cost-effective generation and interpretation of brain-wide wiring diagrams. Funded projects will be integrated into the BRAIN CONNECTS Network consisting of projects funded under this and preceding BRAIN CONNECTS NOFOs, as a coordinated effort aimed at developing the capabilities to generate wiring diagrams that can span entire brains across multiple scales.

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.

Key Dates

Posted Date

May 28, 2026

Open Date (Earliest Submission Date)

June 09, 2026

July 09, 2026

Not Applicable

Not Applicable

April 2027

February 08, 2027

Not Applicable

Not Applicable

December 2027

October 04, 2027

Not Applicable

Not Applicable

July 2028

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.

Due Dates for E.O. 12372

Not Applicable

Expiration Date

October 05, 2027

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.

Table of Contents

Part 1. Overview Information Key Dates 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

The BRAIN Initiative Since 2014, the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative has aimed to accelerate the development and application of innovative neurotechnologies, enabling researchers to produce a new dynamic picture of the brain that reveals how individual cells and complex neural circuits interact in both time and space. It is expected that these advances will ultimately lead to new ways to treat and prevent brain disorders.

As one of several federal agencies involved in the BRAIN Initiative, NIH's contributions to the BRAIN Initiative were initially guided by "BRAIN 2025: A Scientific Vision," a strategic plan that detailed seven high-priority research areas. This plan was updated and enhanced in 2019 by: "The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures" and "The BRAIN Initiative and Neuroethics: Enabling and Enhancing Neuroscience Advances for Society." This and other BRAIN Initiative Notices of Funding 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 require creativity, 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.

The BRAIN Initiative requires a high level of coordination and sharing between 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 BRAIN Initiative Biennial Conference. The data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010.

BRAIN Initiative Connectivity across Scales (BRAIN CONNECTS) This announcement is a reissue of RFA-NS-22-049, from the following suite of BRAIN CONNECTS funding opportunities, to develop scalable technologies for brain-wide mapping of neural connectivity. BRAIN CONNECTS is an anticipated 10-year program to develop the research capacity and technical capabilities to generate wiring diagrams that can span entire brains across multiple scales. The objective of the first five years is to develop these capabilities through innovation, iterative engineering, and optimization for the required throughput and capacity scale-up.

RFA-NS-22-047 UM1 Comprehensive Centers for Human and Non-Human Primate Brain RFA-NS-22-048 UM1 Comprehensive Centers for Mouse Brain RFA-NS-22-049 U01 Specialized Projects for Scalable Technologies RFA-NS-24-028 U24 Data Coordinating Centers Comprehensive Centers funded under RFA-NS-22-047 and RFA-NS-22-048 use the UM1 activity code for large-scale research activities with interdependent components. Funded projects aim to establish full production pipelines, from sample collection through data integration, analysis, and dissemination, applied to sub-volumes that are sufficiently large to prove feasibility of whole-brain mapping, and chosen to test specific hypotheses relating circuit structure to function. Specialized Projects (RFA-NS-22-049 and this re-issue) use the U01 activity code for cooperative agreements to develop current or emerging technologies for scalable mapping of brain connectivity. Data Coordinating Centers (RFA-NS-24-028) facilitate and organize the activities of the BRAIN CONNECTS Network.

Through these awards, the program will support:

Objectives and Requirements for this Announcement Applications to this announcement may address any aspect(s) of the production and analysis pipeline – from data collection, reconstruction, analysis, integration, dissemination, and interpretation of brain connectivity and associated data. The proposed development must aim to enable faster, more precise, and more cost-effective generation and interpretation of brain-wide wiring diagrams. Projects may develop and optimize current technologies or propose entirely new, disruptive, and potentially risky approaches. In all cases, the expectation is that technologies and approaches will be sufficiently scalable to enable brain-wide connectivity mapping in a subsequent five-year follow-on period, if not earlier.

Applications to this announcement are expected to complement existing BRAIN CONNECTS awards with distinct capabilities and competencies. Applicants are strongly encouraged to use NIH RePORTER to retrieve information on awards from each of aforementioned announcements.

The focus of the BRAIN CONNECTS Program is on human, NHP, and mouse brain. For mouse, technologies must demonstrate feasibility of local and long-range cell-to-cell connectivity at the level of synaptic connections. For human and NHP, technologies must demonstrate region-to-region connectivity at the level of axonal projections. Other species are permitted, if their use is well justified and the goal is to test and validate approaches that can be generalized across species.

The BRAIN Initiative Connectivity across Scales (BRAIN CONNECTS) Network Awards funded under this announcement will be integrated into the BRAIN CONNECTS Network for project coordination and program integration. Throughout the funding period, all CONNECTS Network recipients will work cooperatively to further common goals and identify collaborative opportunities. The CONNECTS Network will develop and harmonize common data processing pipelines, integrate and disseminate data analytic tools and capabilities, initiate efforts towards a unified knowledge base for connectivity data from a variety of modalities, and organize and implement outreach and engagement to the wider research community and the general public.

Applications Not Responsive to this Announcement Proposed research that is not responsive to this announcement and will not be reviewed includes the following:

Applicants considering related technologies that may not meet requirements for this announcement should consider other BRAIN Initiative funding opportunities, and in particular the following:

RFA-MH-26-170, BRAIN Initiative: Development and Validation of Novel Tools to Probe Cell-Specific and Circuit-Specific Processes in the Brain (R01 Clinical Trial Not Allowed) Prior Consultation with Scientific/Research Staff Consultation with Scientific/Research Contact staff listed in Section VII is strongly recommended. If requested by the applicants, staff can advise whether the proposed project meets the goals of this NOFO and the mission of the BRAIN Initiative, and discuss responsiveness questions. Staff will not evaluate the technical and scientific merit of the proposed project; technical and scientific merit will be determined during peer review using the review criteria indicated in this NOFO. During the consultation phase, if the proposed project does not meet the programmatic needs of this NOFO, applicants will be strongly encouraged to consider other Funding Opportunities.

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

Section II. Award Information

Funding Instrument

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

New

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.

Clinical Trial?

Not Allowed: This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The NIH BRAIN Initiative intends to commit an estimated total of $10M in the first year for this funding announcement to fund approximately 3-6 awards.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 3 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

Native American Tribal Organizations (other than Federally recognized tribal governments)

Faith-based or Community-based Organizations

Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations)

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. Intellectual property will be managed in accord with established policy of 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. Intramural scientist cannot be MPIs on extramural awards.

Foreign Organizations/International Collaborations

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.

NIH will no longer issue awards (i.e., 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. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

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.

Required Registrations

Applicant Organizations 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. Foreign organizations must obtain a NATO Commercial and Government Entity (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.

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. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

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.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility Number of Applications

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

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

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

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

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). 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.

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

Instructions for Application Submission

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

SF424(R&R) Cover All instructions in the 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

SF424(R&R) Senior/Key Person Profile

R&R or Modular Budget

R&R Subaward Budget

PHS 398 Cover Page Supplement

PHS 398 Research Plan All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims:

In the Specific Aims section, explain how the project will contribute to scalable pipelines for brain connectivity and associated data, and how it will result in new or improved capabilities that can be scaled to whole brains.

Research Strategy:

In the Research Strategy section, detail how the project will contribute to scalable pipelines for brain connectivity and associated data, and how it will result in new or improved capabilities that can be scaled to whole brains. Applications may address any aspect(s) of data collection, analysis, and dissemination pipelines, from tissue processing to data acquisition, alignment, segmentation and annotation, error correction, analysis, integration into the larger neuroscience data environment, and dissemination to the research community. The proposed development must aim to enable faster, more precise, and more cost-effective generation, analysis, and interpretation of brain-wide wiring diagrams.

Describe how the chosen strategies will advance state-of-art technologies and address current gaps and challenges, and why the approaches offer advantages over alternative methods. For entirely new, disruptive, and potentially risky approaches, explain how success of the project will lead to quantitative and/or qualitative gains in brain mapping capabilities. If a new dataset will be generated or analyzed to validate the approach, explain the significance of the data and/or resulting analysis for understanding neural circuit structure and function, and indicate how availability of the proposed data or toolsets will contribute to novel research findings and/or new capabilities for the field. If producing or analyzing data from species other than mouse, NHP, or human, provide justification for the choice of species and explain how the approach can be generalized more broadly.

Funded awards will be integrated into the BRAIN CONNECTS Network, consisting of other Specialized Projects, Comprehensive Centers, and Data Coordinating Centers as a coordinated effort aimed at developing the capabilities to generate wiring diagrams spanning entire brains across multiple scales. Accordingly, proposals should include plans to ensure efficient coordination, communication, and decision support with the other entities of BRAIN CONNECTS Network.

Feasibility Metrics and Milestones: In a separate section of the Research Strategy, provide performance metrics that can be used to demonstrate feasibility of scaling to entire brains and/or comparison to other approaches. Include information on expectations of cost, time, and any ancillary requirements that would affect decisions on project continuation in a potential subsequent funding period. In addition, provide a project timeline and annual milestones using SMART criteria (Specific, Measurable, Attainable, Relevant, and Time-bound). Milestones should be delineated into aspirational but realistic goals vs. go/no-go criteria representing minimally acceptable progress for project success.

Letters of Support: Include as appropriate letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants.

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.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

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

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

PHS Assignment Request Form

Foreign Organizations Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the 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 considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

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

5. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review.

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

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

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply – Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply – 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.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

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

This NOFO will accept a one-page update with preliminary data as post-submission materials. The deadline for submitting all post-submission materials, including preliminary data, will be 30 days before the study section meeting. All other materials listed in NOT-OD-19-083 as acceptable post-submission materials will continue to be accepted if submitted 30 days before the study section meeting.

Section V. Application Review Information

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

For this particular announcement, note the following:

This NOFO supports Specialized Projects to develop current or emerging technologies to generate comprehensive atlases of brain connectivity. Applications may address any aspect(s) of collection, analysis, and dissemination pipelines, from tissue processing to acquisition, alignment, segmentation and annotation, error correction, analysis, integration into the larger neuroscience environment, and dissemination to the research community. The proposed development must aim to enable faster, more precise, and more cost-effective generation and interpretation of brain-wide wiring diagrams. Further development and optimization of current technologies, or entirely new, disruptive, and potentially risky approaches are encouraged, if success of the project will lead to quantitative and/or qualitative gains in brain mapping capabilities. If a new dataset will be generated or analyzed to validate the approach, the significance of the data and/or resulting analysis for understanding neural circuit structure and function must be justified. If using species other than mouse, NHP, or human, justification must be provided for the choice of species and for the broader generalizability of the approach.

Funded projects will be integrated into the BRAIN CONNECTS Network, consisting of other Specialized Projects from this NOFO, and Comprehensive Centers from the companion announcements, as a coordinated effort aimed at developing the capabilities to generate wiring diagrams that can span entire brains across multiple scales.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Scored Review Criteria

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score.

Factor 1. Importance of the Research (Significance and Innovation)

Innovation

Specific to this NOFO:

Significance

Innovation

Factor 2. Rigor and Feasibility (Approach)

Rigor:

For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

Feasibility:

Factor 3. Expertise and Resources (Investigator(s) and Environment)

Investigator(s) Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.

Environment Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects; 2) adequacy of protection against risks; 3) potential benefits to the subjects and others; 4) importance of the knowledge to be gained; and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, evaluate: 1) the justification for the exemption; 2) human subjects involvement and characteristics; and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.

Vertebrate Animals

When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.

Resubmissions

As applicable, evaluate the full application as now presented.

Renewals

As applicable, evaluate the progress made in the last funding period.

Revisions

As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by CSR, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

As part of the scientific…