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)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title
BRAIN Initiative: Research Resource Grants for Technology Integration and Dissemination (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
Reissue of RFA-NS-23-026
Related Notices
Funding Opportunity Number (FON)
RFA-NS-27-001
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.372, 93.853, 93.173, 93.279, 93.286, 93.866, 93.273, 93.213, 93.242, 93.865, 93.867
Funding Opportunity Purpose

This notice of funding opportunity (NOFO) supports efforts to disseminate resources for integration into neuroscience research practice. The resource(s) should be relevant to the goals of the BRAIN Initiative as outlined in the "BRAIN 2025: A Scientific Vision" and "The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures" and shared broadly to the neuroscience community. The resource(s) should address compelling needs of neuroscience researchers that are otherwise unavailable or impractical in their current form. Activities must include dissemination of an existing resource, and may include one or more of the following activities: distribution of tools and reagents; user training on the usage of new technologies or techniques; providing access to existing technology platforms and/or specialized facilities; minor improvements to increase the scale/efficiency of resource production and delivery; minor adaptations to meet the needs of a user community.

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. BRAIN Initiative research adheres to open, and ethical science – and requires diverse expertise across all technical domains.

Key Dates

Posted Date
February 09, 2026
Open Date (Earliest Submission Date)
May 10, 2026
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
June 10, 2026 June 10, 2026 Not Applicable November 2026 January 2027 April 2027
October 06, 2026 October 06, 2026 Not Applicable March 2027 May 2027 July 2027
June 10, 2027 June 10, 2027 Not Applicable November 2027 January 2028 April 2028
February 18, 2028 February 18, 2028 Not Applicable July 2028 October 2028 December 2028
October 06, 2028 October 06, 2028 Not Applicable March 2029 May 2029 July 2029

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.

Expiration Date
October 07, 2028
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. 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.
  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

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 team participation including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, and enhancing public trust

The NIH also encourages businesses to participate in the BRAIN Initiative. It is possible for companies to submit applications directly to BRAIN Initiative program announcements or to collaborate with academic researchers in joint submissions. Small businesses should consider applying to one of the  BRAIN Initiative small business NOFOs

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

This NOFO is related to the recommendations in the BRAIN 2025 (Section III, Part 8b) and the BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures (Priority Area 8, Section III) Reports. Specifically, this NOFO solicits applications that will address the recommendations on "Dissemination and training in new technologies" As noted in the BRAIN 2.0 report “new tools and new knowledge should be shared broadly to maximize the value of the BRAIN Initiative and to seed new paths of inquiry”.

Objectives

The overall goal of this NOFO is to accelerate the scientific impact of the BRAIN Initiative through rapid dissemination of developed and validated technologies and resources broadly to the neuroscience research community. Awards from this RFA will be made for no more than 5 years, with a possibility of one renewal.

Projects may accomplish this goal by engaging in one or more of the following types of activities:

  • Production and distribution of reagents (e.g., antibodies, chemical probes, transgenic lines) using quality control manufacturing processes
  • Services providing customized instrumentation based on end user needs
  • Provision of state-of-art components, devices, or integrated systems (e.g., for assaying neural activity and/or connectivity) either distributed to end users or operated as specialized core facilities with user engagement
  • Resources focused on enabling the translation of neurotechnologies for human use
  • Maintenance, minor enhancements, and distribution of open-source computational models and software packages
  • User facilities that enable scientists from outside institutions to utilize specialized tools or techniques
  • Training in usage of the resource

The following are examples of projects responsive to this NOFO. These are representative, but not exhaustive, examples.

  • Consortium that provides screening services for voltage sensors and other probes for identifying changes in membrane potential or network modulatory states
  • Resource that provides reliable multichannel microelectrodes to the neuroscience community that are compatible with other recording technologies, such as optical imaging and stimulation or MRI
  • Imaging services for large-scale recording of neural activity from multiple brain areas or for large-scale sampling/manipulation of cellular activity with simultaneous whole-brain activity measurements
  • Dissemination of novel miniaturized wireless imaging systems and serving as a core resource for researchers
  • A resource that gathers, standardizes and streamlines the distribution of transgenic mouse models for neuroscience research

This NOFO will support applications which address one or more of the specific goals of the BRAIN Initiative, as described in the planning document "BRAIN 2025: A Scientific Vision" and updated and enhanced in 2019 by "The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures". Applications are not limited to existing BRAIN Initiative investigators or to technologies previously developed using BRAIN Initiative or NIH funds, nor must the end user community be limited to investigators with BRAIN Initiative funding. End users may include those studying disease relevant mechanisms. Projects should address compelling needs of broad communities of investigators or should justify the impact and unmet opportunity of providing the services at smaller scales.

Proposed techniques, resources or approaches must be at a stage wherein the potential value for research is well established, through publications or other demonstration methods, and dissemination must occur by early in year 2. Projects focused on developing novel and unproven technologies are not responsive to this NOFO. Applicants developing new technologies are encouraged to submit to one of the BRAIN technology development NOFOs. Applications to develop web-accessible data archives are strongly recommended to consider funding through RFA-MH-25-110, “BRAIN Initiative: Data Archives for the BRAIN Initiative”. Please see https://www.braininitiative.nih.gov/funding/ for more details about these and other BRAIN Initiative programs.

Integration of proven techniques to produce new experimental systems, or application of existing technologies to produce new reagents such as genetic lines or constructs with an existing technology, are appropriate, but need to be described clearly with timelines for completion of development and testing. Clear value to the intended user group must be demonstrated in the application and dissemination must be planned by early year 2.

For projects proposing the development of novel technologies/resources with commercial potential, potential applicants should consider funding through the Small Business Innovation Research (SBIR) program or the Small Business Technology Transfer (STTR) program. Please see: seed..nih.gov/ for more details about these technology development programs.

Resources are expected to be free from any patent or licensing constraints that would unduly restrict academic research use and impede achieving the goals of this funding program. For resources requiring material from human subjects (e.g. DNA, fibroblasts, blood, tissue), broad sharing of the resource and any derivatives with academic and industry investigators is expected, consistent with achieving the goals of this program and consistent with applicable laws, regulations, and informed consents. In cases where the disseminated resource involves patented materials across several institutions, it is expected that these institutions utilize standard or model agreements in order to reduce negotiation cost and time.

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 NOFO, and the BRAIN Initiative Program.

 

Milestones

The success of the project will be facilitated by the adoption of clear, quantitative milestones with realistic and efficient timelines. Applications must include proposed milestones for each year of requested support, which will be evaluated as part of the review process. The milestones and timeline should include the timing and quantity of dissemination of the resource to the neuroscience community. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn before review. Final version of milestones will be agreed upon at the time of award. If justified, future year milestones may be revised based on data and information obtained in the current year.

 

 

Applications Not Responsive to this NOFO:

Proposed research that is not responsive to this NOFO and will not be reviewed include the following:

  • Projects focused on developing novel and unproven technologies
  • Projects which lack clear indication that the resource is well established and validated, through publications or other demonstration methods.
  • Projects where dissemination is not planned to occur by early year 2.
  • Projects that support clinical trials or provide patient services. Applicants considering such efforts are encouraged to explore alternative funding mechanisms.
  • Projects proposing repositories of brain and related bio-specimens. 

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
Renewal
Resubmission

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: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

The NIH anticipates providing $10M per year to fund an estimated 10 to 20 awards.

Award Budget

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

Award Project Period

Support may be requested for up to 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

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions - Includes all types

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

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

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 a multi-PI on an extramural award.

Foreign Organizations/Foreign Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not 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. This new requirement was effective, May 1, 2025.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

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 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.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement 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 How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

All instructions in the How to Apply - Application Guide must be followed.

Other Attachments:

Proposed Milestones and Timeline: – Applications that do not include this will be withdrawn and not reviewed. Milestones and timeline should be submitted as a separate attachment and must be no more than 2 pages in length. Applications must describe quantitative milestones for each year of support, that will serve as reliable indicators for objective evaluation of progress over the course of the project. The milestones should include realistic quantitative goals for resource usage and dissemination metrics (e.g. number of users, unique labs/institutions) which will be reported at the end of a given annual funding period, and clearly describe when dissemination of the resource will commence. Other common milestones may include user feedback, optimization and standardization, plans for sustainability, and outreach activities. These should include quantifiable measures of success, specific outcomes, and rationale. NIH Program staff will use the project milestones for evaluation of the funded award, and to determine whether to modify or continue the award in subsequent budget years. Applicants should include a project timeline in the form of a Gantt chart (or similar) that includes all major tasks to be performed during the project. The chart should also include estimated start and completion dates for those tasks. Applicants may consider this template in developing their milestone plan, focusing on key milestones consistent with achieving the goals of this program. Applicants should keep in mind continuation of funding will be dependent upon the recipient’s ability to show adequate progress towards milestone accomplishment.

Letters of Support: Letters of support from potential resource users are strongly advised. In their letters, users should describe their research plans with a level of detail sufficient for reviewers to assess the potential impact of the proposed resource. No more than 10 letters from planned or potential end users may be submitted. It is encouraged that these letters demonstrate the applicant has considered how to engage participation from the end user community.  Other letters of support from the institution, key personnel, and key contributors do not count towards these 10 letters of support from end users.  Applications may also include institutional letters which describe financial and collaborative arrangements, and/or agreements for payment for services, or letters which describe third party or strategic partners interest.In cases where the disseminated resource involves patented materials from several institutions, it is expected that these institutions utilize standard or model agreements (e.g. Uniform Biological Material Transfer Agreement) in order to reduce negotiation cost and time, and that these arrangements are described in the letters of support. Such letters must acknowledge awareness by the collaborating institutions that broad sharing of the resource and any derivatives with academic and industry investigators is expected, consistent with achieving the goals of this program.

The Letters of Support attachment of the application should include a cover page listing the name, institution, and proposed role for each individual providing a letter of support.

Fee structure: Applicants may include a 1 page attachment detailing current and/or planned fee structure.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

with the following additional instructions:

Applicants may include project management personnel as Senior/Key Person(s).

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

with the following additional instructions:

The budget should include funds necessary for travel for up to two key personnel to participate in a BRAIN investigator meeting, lasting not more than two days and including up to two overnight stays.

Projects may include budget for project manager.

R&R Subaward Budget

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.

PHS 398 Research Plan

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

Research Strategy: The Research Strategy section must include the following required information.

Technology readiness for dissemination: Describe the current status of the technology and readiness for broad dissemination and if/how the technology has been validated.

Currently Available Facilities and Services: Investigators must specifically define currently available facilities and services that are comparable to their proposed resource and highlight major value their resource will add.

Technology evolution (in Approach): In order to justify the requested length of support (up to 5 years), applicants should provide an evaluation of the speed of technology evolution in the scientific field and provide justification that the user base will maintain and/or grow during the entire support period requested. For example, if the applicant is proposing 5 years of funding, is there evidence based on the speed at which this technology has been evolving in the past few years that indicates that the proposed resource will remain relevant, cutting edge, and highly desirable by the user community over the entire 5 years of support?

Steering Committee (in Approach): A proposed Steering Committee is required to provide guidance and feedback on strategic priorities and on user access and prioritization. The steering committee should also ensure that the project is well integrated, and not redundant, with related efforts on an international scale. The committee should include established researchers with relevant technical and scientific expertise. The composition of this committee depends on the nature and scope of the project, and the committee may include, as appropriate to the project, individuals employed by the PD/PI's institution. Specific committee members do not need to be named to avoid potential conflicts and membership can be negotiated with program staff at the time of award; however, information on the proposed number of members, their scientific expertise, committee operations and frequency of meetings should be included.

Dissemination, Access, and Project Prioritization Plan (in Approach): Projects must describe planned mechanisms for thorough advertisement and dissemination of the resources broadly to the community of relevant investigators. It must be made clear that the resource will be disseminated broadly- to users spanning many unique labs and institutions and not confined to a homogenous user group concentrated in the same geographic region. A concrete Project Prioritization Plan should detail how the capacity of the proposed resource will be evaluated and allocated. Prioritization may be facilitated by a fee structure, by formal project evaluation mechanisms, or by other appropriate considerations. Cost offsets via user fees are not required, but they should be considered as part of the project plan, because they provide potential mechanisms for efficient resource allocation and for resource sustainability. Access should be as broad as possible for the technology, including national and international users where possible.

Quality Assurance and Control Plan (in Approach): Projects must describe the planned strategy and mechanisms for quality control / assurance for the disseminated resource.

Team Management and Logistics Plan (in Approach): Investigators must describe the planned strategy for managing the personnel and resources on the team. The plans should highlight expertise and prior experience in managing any efforts outside the needs of their own research programs.

Progress Report for Renewal Applications (in Approach): Renewal applications must include a detailed account of experiences in dissemination and engagement highlighting outreach to community of  users during the previous funding period, including successful and unsuccessful strategies. Information should be included on how the program's past experiences inform the current plan. Any non-public demographic information collected should be aggregated and anonymized.

PIs proposing a renewal may consider aggregating user institution type using:

PIs may consider aggregating user career stage using:

  • Early career: 0-14 years since terminal degree
  • Mid career: 15-29 years since terminal degree
  • Late career: 30+ years since terminal degree

Renewal applicants are expected to have sought additional resources to maintain their operations after NIH funding and should include plans for other sources of support for program sustainability, including descriptions of all institutional support, financial and collaborative arrangements, and/or agreements for payment for services. Appropriate documentation should be included in the application- see instructions under “Other Attachments”. Provide other relevant information about the applicant’s approach for self-sustaining infrastructure and operations, and why NIH support in particular is needed to disseminate this resource.

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:

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.

  • Consistent with authorities under the 21st Century Cures Act, all applications to BRAIN Initiative NOFOs must include a Data Management and Sharing Plan. The BRAIN Initiative data sharing policy (NOT-MH-19-010) establishes the expectation that this plan should include:
    1. a summary of the data that will be shared;
    2. a description of the standard(s) that will be used to describe the data;
    3. the archive(s) that will house the data; and
    4. the proposed timelines for submitting data to the archive and for sharing data with the research community.
  • An updated listing of BRAIN Initiative archives can be found at https://braininitiative.nih.gov/brain-programs/informatics. Currently established archives that may be relevant to this funding opportunity include, but are not limited to:
    1. Distributed Archives for Neurophysiology Data Integration (DANDI; https://www.dandiarchive.org; R24MH117295) for cellular neurophysiology data;
    2. The Neuroscience Multi-omic Data Archive (NeMO; https://nemoarchive.org/about; R24MH114788) for data from -omics experiments;
    3. The Brain Image Library (BIL; https://www.brainimagelibrary.org; R24MH114793) for confocal microscopy data;
    4. Data Archive for the BRAIN Initiative (DABI; https://dabi.loni.usc.edu; R24MH114796) for data related to human invasive device research;
    5. OpenNeuro (https://openneuro.org; R24MH117179) for magnetic resonance imaging and other neuroimaging data; and
    6. Block and Object Storage Service (BossDB; https://bossdb.org; R24MH114785) for electron microscopy and x-ray microtomography data.
  • 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.

    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

    All instructions in the How to Apply - Application Guide must be followed.

    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

    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.

    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 review criteria and additional review criteria (as applicable for the project proposed).

    Scored Review Criteria

    Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

     

    Does the proposed [Center] address the needs of the research [programs/projects/network/consortium/resource] that it will [coordinate/administer/serve]? Is the scope of activities proposed for the [Center] appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research [program/projects/network/consortium/resource]?

    Specific to this NOFO:

    Will the proposed resource contribute substantially to the quality of neuroscience research? From details provided in the letters of support, will it convincingly add major value over any comparable facilities and services? Is the technical resource developed to an appropriate stage (has validation been performed?) that the technology is ready for broad dissemination and not further development and beta testing? Is it unlikely that another technology will usurp the proposed technology in the period of support proposed and that the user base will maintain or grow in requested period of support?


     

    Are the PD(s)/PI(s) and other personnel well suited to their roles in the [Center]? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing [adjective] research? Do the investigators demonstrate significant experience with coordinating collaborative [basic or clinical] research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their [leadership approach, governance, plans for conflict resolution, and organizational structure] appropriate for the [Center]? Does the applicant have experience overseeing selection and management of subawards, if needed?

    Specific to this NOFO:

    Do the PD(s)/PI(s) have a history of service-oriented efforts outside the needs of their own research programs? Are they uniquely positioned to provide the proposed resource? Are the PD(s)/PI(s) and other personnel well suited to organize and maintain the resource, maintain quality control and unbiased access?


     

    Does the application propose novel [organizational concepts, management strategies, or instrumentation] in coordinating the research [program/projects/network/consortium/resource] the [Center] will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of [organizational concepts, management strategies or instrumentation] proposed?

    Specific to this NOFO:

    Is the resource that is being provided to the end user one that is not currently available or that is prohibitively difficult to distribute? Is the resource of a nature that the end user could not reasonably implement him/herself in the absence of this mechanism? Does the proposed resource enable novel and innovative research that otherwise would not be feasible?


     

    Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research [program/projects/network/consortium/ resource] the [Center] will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the [program/projects/network/consortium/resource], as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the [program/projects/network/consortium/ resource] is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the [program/projects/network/consortium/resource]? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

    Specific to this NOFO:

    Are the proposed Steering Committee and Access and Prioritization Plan well-reasoned and appropriate for the project? Is the quality assurance and quality control plan described and appropriate for ensuring quality resources are being disseminated? Has a scale-up plan been included and is it appropriate for ensuring the sharing of resources broadly? Are the outreach activities and project prioritization plan likely to ensure a highly qualified and broad user pool?


     

    Will the institutional environment in which the [Center] will operate contribute to the probability of success in facilitating the research [program/projects/network/consortium] it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the [Center] proposed? Will the [Center] benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?


    Additional Review Criteria

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

    Specific to this NOFO:

    • Milestones and Timeline
      • Are the Proposed Milestones for the project overall described in sufficient detail and are they appropriate for the project?  Are the milestones feasible, well-developed, and quantifiable with regard to the specific aims? Do the milestones and timeline describe well and reasonably the timing and quantity of dissemination of reagents to the neuroscience community? Is the proposed Sustainability Plan well-reasoned and appropriate for the project?
     

     

    For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will 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, the committee will 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.


     

    When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research


     

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.


     

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.


     

    For Resubmissions (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.


     

    For Renewals, the committee will consider the progress made in the last funding period, and the success of the program in broadly disseminating the resource during the previous funding period, particularly to investigators with diverse technical expertise, including successful and unsuccessful strategies. It will also consider the evaluation activities conducted by the program in the last funding period and the evolution and improvement of the program already made and/or proposed in response to these evaluations. Particular attention will be given to sustainability activities in the previous period and justification for why continued NIH funding is required.


     

    For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.


    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.

     

    Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

    Not applicable.


     

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).


     

    Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.


     

    For [programs/projects/networks/consortia/resources] involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.


     

    Reviewers will consider 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 Center for Scientific Review (CSR),, in accordance with NIH peer review policy and procedures, 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.

    Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

    Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

    Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke Council. The following will be considered in making funding decisions, consistent with applicable law.

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

    Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

    Section VI. Award Administration Information

    1. Award Notices

    A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

    In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

    Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

    Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

    2. Administrative and National Policy Requirements

    The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

    All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

    By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

    Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.” 

    Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

    Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

    Successful recipients under this NOFO agree that:

    When recipients, subrecipients, or third-party entities have:

    1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
    2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

    Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

    Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

    The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

    The PD(s)/PI(s) will have the primary responsibility for:

    • Determining experimental approaches, designing protocols, conducting experiments, analyzing, interpreting and publishing research data
    • Attending meetings with investigators, BRAIN Initiative staff and/or leadership, and members of the BRAIN Initiative Multi-Council Working Group to foster collaborations and exchange information and ideas to accelerate progress towards the goals of the BRAIN Initiative.
    • Developing milestones with specific timelines and criteria for evaluation, and making appropriate revisions based on the feedback from the Principal Investigator meetings and recommendations from the Program Officer and/or Project Team.
    • Discussing and sharing information, preliminary results, raw data, resources, and technology with the Program Officer and/or Project Team and the other investigative teams (i.e., recipients of awards issued under this NOFO) as appropriate and consistent with achieving the goals of the BRAIN Initiative.
    • Sharing data, final results and technology with the broader research community as appropriate.
    • Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

    NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

    • A Program Officer will be assigned to this award. The Program Officer will be responsible for normal scientific and programmatic stewardship and guidance.
    • A group of NIH program staff from the ICs contributing to the NIH BRAIN Initiative will form a Project Team for this award. The Project Team will review annual progress reports and other documents from the recipients and will assist the Program Officer in the evaluation of progress and coordination of activities with other recipients under this NOFO.
    • One or more extramural NIH program staff member will be assigned as the Project Coordinator for each award under this NOFO. The same person may serve as the Project Coordinator for multiple BRAIN Initiative awards.
    • The Project Coordinator will provide technical assistance, advice, coordination, and other program actions supporting the Program Officer and recipients of these cooperative agreements during the conduct of an activity, which may be above and beyond the levels required normally for program stewardship of grants.
    • The additional duties of the Project Coordinator may include attending and participating in meetings of Principal Investigators and NIH Staff, assisting in the development of the meeting agendas, assisting in evaluating achievement of milestones, assisting with the establishment of a consortium for the purpose of sharing information and coordination of research activities among the recipients of these cooperative agreements.

    Areas of Joint Responsibility include:

    • The PI, the Program Officer and the Project Coordinator will work together to clarify and negotiate the milestones and timelines.
    • Establishing a Steering Committee (SC)to provide guidance and feedback on strategic priorities and technology optimization for eventual reliable, sustainable manufacture suitable for broad dissemination and integration into regular neuroscience practice. The SC will include at least three established researchers with relevant technical and scientific expertise. Specific SC members should not be named in the grant application and membership will be negotiated with program staff at the time of award. At least one meeting per year should be planned. NIH program staff are required to be invited to all steering committee meetings.NIH staff will not participate in voting. 

    Dispute Resolution:

    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

    3. Data Management and Sharing

    Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

    Additionally, in accordance with the Notice of Data Sharing Policy for the BRAIN Initiative (NOT-MH-19-010), recipients of BRAIN Initiative awards will be required to share the data they collect using the BRAIN Initiative informatics infrastructure (both data archives and relevant data standards), consistent with authorities under the 21st Century Cures Act and these awards authorized under that Act. Recipients will be expected to coordinate with Program Staff to select appropriate BRAIN Initiative data archives and to submit data to the selected archives every 6 months of the award period. Submitting data to an archive is distinct from sharing that data with the research community. Submitted data will be held in a private enclave until the data are shared with the research community. After the data have been submitted to the appropriate data archive, it will be shared with the research community when papers using the data have been published or at the end of the award period, whichever occurs sooner.

    4. Reporting

    When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

    A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

    Application Submission Contacts

    eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.

    Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

    Scientific/Research Contact(s)

    The NIH BRAIN Initiative
    National Institute of Neurological Disorders and Stroke (NINDS)
    Email: BRAIN_Dissemination@mail.nih.gov

    Peer Review Contact(s)

    Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

    Financial/Grants Management Contact(s)

    Chief Grants Management Officer
    National Institute of Neurological Disorders and Stroke (NINDS)
    Email: ChiefGrantsManagementOfficer@ninds.nih.gov

    Section VIII. Other Information

    Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.