Part 1. Overview Information

Key Dates

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.

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.



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

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 Opportunity (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.

The NIH BRAIN Initiative recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

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

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

This NOFO is related to the transformative project, "A Cell Type-Specific Armamentarium for Understanding Brain Function and Dysfunction," described in the "The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures" report of the Advisory Committee to the NIH Director (ACD) BRAIN Initiative Working Group 2.0, which was adopted by the ACD.

Broad Dissemination of Enabling Technologies for Brain Cell Type-Specific Access and Manipulation

Recent progress in experimental neuroscience has been driven by new methods and technologies. These have in turn inspired new discoveries and hypotheses. Among new technologies are reagents to access and manipulate specific brain cell types in experimental animals and human ex vivo tissue and cells (e.g., adeno-associated viral (AAV) vectors, lentiviral (LV) vectors, rabies viral vectors, nanoparticles, improved transgenic engineering methods, molecular sensors of neural activity, optogenetic and chemogenetic effector proteins, gene editors). These molecular and genetic tools enable the dissection of neural circuit function through the precise delivery of mapping, monitoring, and manipulation reagents. Novel reagents have enabled the description of neural activity with sub-second timing and across thousands of individual neurons in behaving animals. A dynamic and detailed picture of the brain in relation to behaviors has started to emerge.

Increasing numbers of brain cell types are being defined based on comprehensive transcriptomic, epigenomic, and anatomical profiling. Significant progress has been made in defining this diversity through a census of mammalian brain cell types, supported by the BRAIN Initiative Cell Census program. The BRAIN Initiative Cell Census effort was initiated in 2014 to define a brain parts list with unprecedented detail through molecular and anatomical profiling of the mouse, non-human primate, and human brain. By 2023, the program together with other efforts succeeded, for example, in defining nearly 5000 cell types in the mouse brain with transcriptomic and anatomical position information. Many more brain cell types have been and will continue to be delineated in other mammalian species including humans.

The BRAIN Initiative Armamentarium project intends to leverage this brain cell type information to create molecular or genetic access reagents to deliver mapping, monitoring, and manipulation payloads to distinct circuit components. The intention is for the breadth of Armamentarium project reagents to transform the dissection of neural circuits underlying behavior by experimental neuroscientists.  The Armamentarium project is conceptually aimed at enabling unique access to each molecularly defined brain neural cell type that could exhibit a distinct cellular, circuit, or behavioral function. The BRAIN Initiative Armamentarium project began with 8 awards made in 2021-2023 under RFA-MH-20-556 and RFA-MH-21-180.  These initial awards formed the Armamentarium Consortium. The goal of the consortium was to pilot evaluation of scalable molecular genetic technologies and production and distribution resources for cell type-selective reagents across several vertebrate species. Scalable technologies were established in several areas, including:  improved gene regulatory element discovery, engineering of more selective viral vector tropism, multiplexed screening for specific enhancers and minimally invasive viruses in various species, novel RNA editing-based and microRNA control strategies, and higher throughput in situ hybridization validation methods.  Based on this progress, the Armamentarium project is supporting further scale up of cell type-selective access including by Reagent Resources for Design and Development (RRDDs) through RFA-MH-25-100.  This NOFO is intended to augment the production and distribution of reagents from the Armamentarium project.

As progress in experimental neuroscience has been driven by new methods, broader distribution of these enabling technologies could augment research capability and increase their impact on the study of the brain. Specialized reagent production infrastructure will be needed. Many institutions with scientists from a diversity of backgrounds are under-resourced, and their faculty receive fewer NIH research grants. This NOFO aims to enhance neuroscience research infrastructure at under-resourced institutions. Part of the goal is to support the establishment of facilities at Resource-Limited Institutions (RLIs) for scaled production and distribution of brain cell type-specific access and manipulation reagents.

Likewise, the NIH has supported, through the National Institute of General Medical Sciences (NIGMS), the Institutional Development Award (IDeA) program to increase the geographic distribution of NIH funding for biomedical research. The IDeA program is one of "multiple strategies to build research infrastructure" ("National Institute of General Medical Sciences 5-Year Strategic Plan," May 2021).

Consistent with the above text, the goals of this NOFO are to broaden distribution of specific enabling technologies for neuroscience and promote Armamentarium project reagent production infrastructure at RLIs, as defined in Section III, and institutions in IDeA-eligible states.  Broadening distribution of Armamentarium reagents is expected to promote advanced technology integration and research infrastructure development.

Resource Objectives

Reagent resources supported under this NOFO must include three main functions. First, the resources will interface with Armamentarium reagent design and development projects (award recipients from   RFA-MH-25-100 or other Armamentarium NOFOs), who will design, validate, and catalogue brain cell type-selective reagents. Second, the resources will conduct scaled-up production of the designed and validated reagents. Third, the resources will disseminate reagents to neuroscience research users. Facilities are sought to enable access to brain cell types in vertebrate species that are of significant interest to neuroscience researchers. Such resources are envisioned to support especially investigation of brain cell types and/or species with previously limited access.

Research Scope

1. Interfacing with Armamentarium Reagent Design and Validation Projects

Applicants must propose plans to partner with at least one Armamentarium reagent design and development project (recipients of awards from RFA-MH-25-100 or other Armamentarium NOFOs). Plans must be described to receive validated reagent designs, reagent templates, and/or seed reagents from the partner(s). A significant proportion of the reagent designs, templates, and/or seed reagents from the partner(s) must be received. Plans must also be described for interfacing with the partner(s), for example, to improve the reagents, further validate reagents, optimize the scaling up of reagent production, and/or augment cataloguing of the reagents. The reagent types for production will depend on the nature and progress of the Armamentarium reagent design and development projects. The types of reagents to be produced could include but are not limited to viral vectors, nucleic acid constructs, and nanoparticles designed for selective access to and manipulation of brain cell types. NIH will facilitate additional collaborations with the Armamentarium reagent design and development project as appropriate through a research consortium (see further below).

2. Scaled-up Reagent Production

Applicants must propose plans to scale up production of a significant proportion of the reagents from the partner(s). The plans must detail strategies for scaled-up reagent production at an RLI or IDeA-eligible institution. Institutional commitment must be assured for the planned reagent production facilities and can include provision of adequate staff, facilities, and training resources that can contribute to the planned reagent production. Quality control metrics for reagents must be described, and quality assurance for the production processes must be delineated. Applicants must describe plans for the characterization, formulation, evaluation, and validation of the efficacy, reproducibility, stability, activity, and unique characteristics of produced reagents. Reagents for in vivo use must be proposed to be highly purified and produced in a manner safe and appropriate for use in animals and/or human ex vivo tissue and cells. Storage, inventory management, and domestic and international distribution approaches must be outlined.

3. Disseminating Reagents to Neuroscience Research Users

Applicants must propose plans to catalogue scaled-up product inventory for dissemination to users in the neuroscience community generally, including those at RLIs, institutions in IDeA-elgible states, and elsewhere. Such catalogues must be made widely accessible and kept updated. Plans to manage reagent delivery to users must be described. Efforts to assess the ongoing user demand for various reagents as well as to receive and incorporate constructive user feedback must be outlined. Applicants are required to propose creation of a website to achieve the above user interface objectives.

Successful applicants will be responsible for management and oversight of large-scale production and distribution activities including, but not limited to, material transfer and licensing agreements, webhosting, and recovery of production and distribution costs. Applicants are expected to include project management effort and personnel for proposed facilities for the production and dissemination of reagents.

Applications may propose to incorporate technology development and optimization, but these efforts should be integrated into a larger reagent production and distribution project. For example, technology development and optimization could be incorporated to augment or improve existing methods for scaled-up reagent production based on feedback from reagent users.

Working Together in the Armamentarium Consortium

Supported projects are expected to work closely together and benefit from membership in the Armamentarium Consortium of researchers, including other Armamentarium award recipients from this NOFO, RFA-MH-25-100, RFA-MH-25-105, RFA-MH-22-245, and subsequent NOFO reissues. Coordination among consortium members is expected to include sharing of technologies, reagents, and data to improve brain cell type-selective access reagents, as well as cooperation in publication and reagent distribution to integrate the best technologies into neuroscience research. This consortium is expected to include tool developers and disseminators funded by several Armamentarium efforts for brain cell access reagent engineering, reagent production and distribution, and optimization of high-impact reagents for monitoring and manipulating brain cell activity.  The consortium will include regular meetings and other coordinated activities within the consortium as well as in the BRAIN Initiative more broadly.

Milestones and Timeline

Applications must include proposed milestones and a proposed timeline, both of which will be evaluated as part of the review process, but final versions of each 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. The milestones and timeline should include the timing and quantity of dissemination of reagents to the neuroscience community.

Examples of responsive research activities include, but are not limited to:

• Scaled-up production of adeno-associated viral (AAV) or lentiviral (LV) vectors containing transcriptional regulatory elements that enable selective or specific expression of neural activity monitoring or manipulation payloads in molecularly defined brain cell types that could have functional relevance.
• Dissemination of cell type access and manipulation reagents for brains of vertebrate animals and/or human ex vivo brain tissue or cells to identify, characterize, and/or alter potentially disease-relevant neural cells or circuits.
• Distribution of reagents related to scalable use of somatic cell, CRISPR gene editing to knock in monitoring or manipulation constructs to a collection of gene loci that contain cis regulatory elements that drive expression in specific brain cell types.
• Large-scale production of AAV capsid variants to selectively transduce brain neural cell types.
• Widescale dissemination of lipid nanoparticles containing surface proteins that mediate selective transduction of brain neural cell types with genetic constructs.
• Manufacturing of LV vectors pseudotyped with antibody or nanobody proteins to mediate selective transduction of brain neural cell types targeting cell surface antigens.
• Scaled-up production of transgenic mouse, rat, zebrafish, or other vertebrate responder lines containing widely used reporter, monitoring, or manipulation constructs that can be combined with molecular access driver reagents to be expressed in specific brain neural cell types.
• Scaled dissemination of transgenic or genome engineered animals having knock in reporter, monitoring, or manipulation constructs passed through the germline and targeted to gene loci for brain cell type-specific expression in a manner that very substantially reduces the time, cost, and breeding required by current methods in experimental vertebrate organisms.
• Large-scale production of combinations of molecular access reagents that intersectionally refine expression or delivery of monitoring and manipulation constructs to brain cell types with greater specificity.
• Creation and maintenance of website-based catalogues of produced access reagents for users, showing inventory levels, efficacy, reproducibility, stability, activity, and unique characteristics of reagents; providing data on ongoing demand; and enabling receipt and incorporation of constructive user feedback.
• Scaled distribution of a collection of systemically administered viral or non-viral reagents that efficiently cross the blood brain barrier and direct construct expression to molecularly defined brain cell types and that detarget peripheral organs.
• Distribution of reagent use protocols that define parameters and methods for brain cell type-selective reagent use administered systemically or intracranially to minimize undesirable, perturbative effects of vectors or payloads.
• Large-scale brain cell type-selective reagent manufacturing and dissemination platforms that ensure quality control, quality assurance, and adequate supply for neuroscience community users, including assessment of the quality of reagents.
• Scaled production of collections of viral or non-viral vectors that enable neuronal projection mapping of or transsynaptic tracing initiated from defined brain cell types.
• Widescale distribution of RNA-based reagents to target brain cell types based on nucleic acid complementarity, protein-RNA interaction, or nanoparticle delivery.
• Integration of data on reagent performance, improvement of reagents, and provision of feedback to reagent designers.
• Further validation of reagent specificity and efficacy in gaining access to brain cell types in terms of testing in a broader range of experimental organisms, assaying additional payloads for monitoring or manipulating circuit components, or examining more combinations of molecular access reagents that intersectionally target expression.
• Organization of reagent inventories and management of domestic and international deliveries to users.

Non-responsive Areas of Research

The following research areas are considered outside the scope of this NOFO, and such applications will be considered non-responsive and will not be reviewed:

• Applications that fail to propose to address all three main functions of a resource where: (1) the resource will interface with Armamentarium reagent design and validation projects, who will design, validate, catalogue, and produce brain cell type-selective reagents; (2) the resource will conduct scaled-up production of the designed and validated reagents; (3) the resource will disseminate reagents to neuroscience research users.
• Applications that fail to include proposed milestones and a proposed timeline.
• Applications primarily focused on the pursuit of a biological mechanism or a hypothesis through basic research that does not result in the generation of a scaled-up reagent production and distribution resource.
• Studies primarily focused on technology development that do not propose a scaled-up reagent production and distribution resource. Note: Applications for technology development may be submitted to other BRAIN Initiative NOFOs (including RFA-MH-23-295, RFA-MH-24-280, or subsequent NOFO reissues).

Applicants are strongly encouraged to consult the NIMH Scientific/Research Contact(s) listed below to discuss the alignment of their proposed work with the NOFO and BRAIN Initiative program goals.  A technical assistance webinar will be held for potential applicants on Thursday, December 12, 2024, from 2:00-3:00 PM ET. NIH staff will be available to answer questions related to this NOFO. To obtain participant information, please contact by email the NIMH Scientific/Research Contact(s) listed below at least 24 hours prior to the technical assistance webinar and specify the NOFO number in the subject line or in the body of the email.

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

Plan for Enhancing Diverse Perspectives (PEDP)

The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams. There are many benefits that flow from a scientific workforce rich with diverse perspectives, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation.  Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project. Consistent with federal law, the race, ethnicity, or sex (including gender identify, sexual orientation, or transgender status) of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions.  Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

The PEDP will be submitted as Other Project Information as an attachment (see Section IV).  Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance materials.

Section II. Award Information

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

Higher Education Institutions

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

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

• 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- Including the NIH Intramural Program
• 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

The overarching goal of this program is to enhance diversity among BRAIN Initiative research area institutions through research infrastructure support at:

• Resource-Limited Institutions (RLIs), defined as institutions that have received an average of $0 to $25 million per year (total costs) of NIH Research Project Grants (RPG) support for the past three fiscal years and that: (1) have a documented historical mission to educate students from any of the populations that have been identified as underrepresented in biomedical research as defined by the National Science Foundation (NSF; see http://www.nsf.gov/statistics/wmpd; i.e., African Americans or Blacks, Hispanic or Latino Americans, American Indians, Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and persons with disabilities), or (2) have a documented historical commitment to recruiting, training and/or educating, and graduating underrepresented students as defined by the NSF (see above), or
• Institutions from IDeA-eligible states and jurisdictions (those with historically low NIH grant funding success rates); see https://www.nigms.nih.gov/Research/DRCB/IDeA) for a current list.

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. 

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.

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. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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. 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Email: [email protected]

Page Limitations

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

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.

Plan for Enhancing Diverse Perspectives (PEDP)

• In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of actionable strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity.
• Applicants should align their proposed strategies for PEDP with the research strategy section, providing a holistic and integrated view of how enhancing diverse perspectives and inclusivity are buoyed throughout the application.
• The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.
• The PEDP may be no more than 2 pages in length and should include:
  • Actionable strategies using defined approaches for the inclusion of diverse perspectives in the project;
  • Description of how the PEDP will advance the scientific and technical merit of the proposed project;
  • Anticipated timeline of proposed PEDP activities;
  • Evaluation methods for assessing the progress and success of PEDP activities.

Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:

• Partnerships with different types of institutions and organizations (e.g., research-intensive; undergraduate-focused; HBCUs; emerging research institutions; community-based organizations).
• Project frameworks that enable communities and researchers to work collaboratively as equal partners in all phases of the research process.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as human subjects in clinical trials, including those from underrepresented backgrounds.
• Description of planned partnerships that may enhance geographic and regional diversity.
• Outreach and recruiting activities intended to diversify the pool of applicants for research training programs, such as outreach to prospective applicants from groups underrepresented in the biomedical sciences, for example, individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Plans to utilize the project infrastructure (i.e., research and structure) to enhance the research environment and support career-advancing opportunities for junior, early- and mid-career researchers.
• Transdisciplinary research projects and collaborations among researchers from fields beyond the biological sciences, such as physics, engineering, mathematics, computational biology, computer and data sciences, as well as bioethics.

Examples of items that are not appropriate in a PEDP include, but are not limited to:

• Selection or hiring of personnel for a research team based on their race, ethnicity, or sex (including gender identify, sexual orientation, or transgender status).
• A training or mentorship program limited to certain researchers based on their race, ethnicity, or sex (including gender identify, sexual orientation, or transgender status).

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP guidance materials.

SF424(R&R) Senior/Key Person Profile

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

Applicants may include project management personnel for the proposed facilities for the production and dissemination of reagents as Senior/Key Person(s).

R&R Budget

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

Include as aspects of annual budgets the following costs:

• Costs for product development, characterization, and testing to maintain a minimal inventory of reagents. Costs should include the purification, formulation, vialing, characterization, evaluation, quality control, quality assurance and/or other related activities.
• Costs for project management and website/catalogue development and maintenance.
• Costs for attendance at the anticipated annual in-person meeting for the consortium of award recipients.
• Costs for 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, for each year of the project.

Do not budget for:

• Production costs to manufacture reagents beyond the minimal inventory for distribution. Neuroscience research users requesting reagents will pay for production costs.
• Shipment and delivery of reagents. Neuroscience research users requesting reagents will pay for shipping costs.

PEDP implementation costs:

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7): https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm.

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

Applicants must include as part of the research strategy:

1. Plans for the resource to interface with at least one Armamentarium project reagent design and development project (award recipients of RFA-MH-25-100 or other Armamentarium NOFOs), who will design, validate, catalogue, and produce brain cell type-selective reagents. This must include plans to:

• Partner with at least one Armamentarium reagent design and development project.
• Receive validated reagent designs, reagent templates, and/or seed reagents from the partner(s). A significant proportion of the reagent designs, templates, and/or seed reagents from the partner(s) must be planned to be received.
• Interface with the partner(s), for example, to improve the reagents, further validate reagents, optimize the scaling up of reagent production, and/or augment cataloguing of the reagents.

2. Plans for the resource to conduct scaled-up production of the designed and validated reagents. This must include plans to:

• Scale up reagent production at an RLI or IDeA-eligible institution of a significant proportion of the reagents from the partner(s).  Provide support for the feasibility of the proposed reagent production activities and how they relate to the strengths of the institution, such as track record in workforce training, technology/research infrastructure development in rural areas, etc.
• Control the quality of reagents and assure the quality of production processes.
• Characterize, formulate, evaluate, and validate the efficacy, reproducibility, stability, activity, and unique characteristics of produced reagents.
• Highly purify and produce reagents in a manner safe and appropriate for use in animals and/or human ex vivo tissue and cells.
• Store reagents, manage inventory, and distribute reagents domestically and internationally.

3. Plans for the resource to disseminate reagents to neuroscience research users. This must include plans to:

• Catalogue scaled-up product inventory for dissemination to users in the neuroscience community. Such catalogues must be planned to be made widely accessible and kept updated.
• Manage reagent delivery to users.
• Assess the ongoing user demand for various reagents as well as to receive and incorporate constructive user feedback.
• Create a website to achieve the above user interface objectives.
• Manage and oversee large-scale production and distribution activities including, but not limited to, material transfer and licensing agreements, webhosting, and recovery of production and distribution costs.
• Conduct project management for proposed facilities for the production and dissemination of reagents.

Proposed Milestones and Timeline

Applicants must include as part of the research strategy proposed milestones and a proposed timeline for achieving the three above elements.

Letters of Support

A letter of institutional commitment for each facility proposed at an RLI or IDeA-eligible institution must be attached.  Each institution must assure support for the proposed facility. Appropriate institutional commitment to a facility includes the provision of adequate staff, facilities, and training resources that can contribute to the planned facility.

Provision of Letters of Support from potential facility users is encouraged. In the letters, users should describe their research plans with a level of detail sufficient for reviewers to assess the potential impact of the proposed facility. No more than 3 letters from potential end users may be submitted.

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.

Please note that the race, ethnicity, or sex of an institution's current students or faculty is not a factor in determining eligibility and will not be considered as a factor in the application review process or when making funding decisions.

Program Income

Applicants should describe plans for Program Income, if any, including the expected charges to the neuroscience research community for distributing reagents.

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 proposedtimelines for submitting data to thearchive and for sharing data with the research community.

An updated listing of BRAIN Initiative archives is provided at the BRAIN Informatics website. Currently established archives that may be relevant to this funding opportunity include, but are not limited to:

1. Distributed Archivesfor 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.

Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as co-investigators in accord with the Terms and Conditions provided in this Notice of Funding Opportunity (NOFO). Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

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

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.

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.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

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.

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 [email protected]. 

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.

For this particular announcement, note the following:

Because this NOFO specifically seeks applications to scale up the generation of brain cell type-specific reagents, the NIH expects that some applications may propose mature and well-established approaches that may not be innovative per se to produce robust high-quality reagents for broad use by the research community.

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).

As part of the overall impact score, reviewers should consider and indicate how the Plan to Enhance Diverse Perspectives affects the scientific merit of the project.

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.

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIMH, 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 on the basis of established PHS referral guidelines 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

Please note that the reviewers will not consider race, ethnicity, age, or gender (including gender identity, sexual orientation or transgender status) of a researcher, award participant, or trainee, even in part, in providing critques, scores, or funding recommendations. NIH will not consider such factors in making funding decisions.

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:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

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.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

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:

• Produce and deliver reagents to the neuroscience research community.
• Determine and coordinate the research approaches and procedures, conduct experiments, and analyze and interpret research data generated under this award.
• Meet or exceed the timeline stated in their application.
• Agree to participate as a voting member in a Consortium Steering Group composed of other recipients from this NOFO and RFA-MH-20-556, RFA-MH-21-180, RFA-MH-22-245, RFA-MH-25-100, RFA-MH-25-105, NIH staff, and an external expert group.
• Share protocols, technologies, reagents, and data with consortium members.
• Not disclose confidential information obtained from other consortium members.
• Ensure that results are published in a timely manner.
• Coordinate with other consortium members the publication of research results, dissemination of reagents, and dissemination of data.
• Submit protocols, reagents, and data for use, quality assessment, and/or validation in any manner specified by the Steering Group or the NIH Project Scientist.
• Submit annual milestone reports to the NIH with completeness that include experimental design with rigor, including assumptions for the design of the experiments, the results of the investigations, interpretations of the results, and for concluding whether milestones have been met or not.
• Provide updates at least annually on implementation of the PEDP.
• Accept and implement common guidelines and procedures approved by the Steering Group.
• Attend Steering Group meetings. It is likely that there will be one in-person meeting per year and that other meetings will be held by telephone or using internet-assisted meeting software.
• Recipients will retain custody of and have primary rights to the data and resources developed under these awards, subject to Government rights of access consistent with current DHHS, 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 and will be named in the Notice of Award.
• Prior to award, the Program Officer will negotiate final milestones with the PD/PIs that will be incorporated into the Notice of Award.
• A group of NIH program staff from the ICs that make up the NIH BRAIN Initiative will form a Project Team for this award.
• The Project Team will include the Program Officer for these BRAIN Initiative awards.
• The Project Team will review annual progress reports and other documents from the recipients and will advise the Program Officer about their view of the progress being made by the recipient as well as about progress being made by others in the field.
• One or more extramural NIH program staff member will be assigned as Project Scientist for this award. The same person may serve as a Project Scientist for multiple BRAIN Initiative awards.
• The Project Scientist(s) will interact scientifically with the PDs/PIs of the cooperative agreement and other named key personnel as a partner in the research activities.
• The Project Scientist(s) will assist in research planning, presenting experimental findings from an award from published sources or from relevant award projects, participate in the design of experiments agreed to by the recipient, participate in the analysis of results. The Project Scientist will also monitor the project to ensure ensure that duplication is avoided.
• The Program Officer and the Project Scientist(s) will be members of the Steering Group.

Areas of Joint Responsibility include:

• The purpose of the Steering Group is to transfer information and technologies among the recipients of this NOFO, RFA-MH-20-556, RFA-MH-21-180, RFA-MH-22-245, RFA-MH-25-100, RFA-MH-25-105and between the recipient and the BRAIN Initiative more broadly in order to achieve the goals outlined in the BRAIN 2025 and BRAIN 2.0 reports.
• The Steering Group will be comprised of the PDs/PIs of the awards of this NOFO, RFA-MH-20-556, RFA-MH-21-180, RFA-MH-22-245, RFA-MH-25-100, RFA-MH-25-105, the Project Scientist(s), and a group of external experts.
• The PDs/PIs and Project Scientist(s) will invite a group of external experts to attend Steering Group meetings. The external expert group will be composed of three to five scientists who are not recipient of this NOFO, RFA-MH-20-556, RFA-MH-21-180,RFA-MH-22-245, RFA-MH-25-100, or RFA-MH-25-105, represent the broad research community, and have relevant expertise. The group may be enlarged permanently or on an ad hoc basis as needed.
• A chair of the Steering Group, who is a recipient of this NOFO, RFA-MH-20-556, RFA-MH-21-180, RFA-MH-22-245, RFA-MH-25-100, or RFA-MH-25-105, will be designated by the Steering Group on a rotating basis as needed.
• It is expected that most of the decisions on the activities of the Steering Group will be reached by consensus. If a vote is needed, each award, as represented by a PI/PD,  will have one vote and the Project Scientist(s) collectively will have one vote. When a vote is required, at least 60% of the votes will be required for approval.
• The Program Officer and the external expert group members will attend Steering Group meetings as non-voting observers.
• In all cases, the role of NIH staff will be to assist and facilitate, but not to direct activities.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: 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 HHS 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.

• Recipients will provide updates at least annually on implementation of the PEDP.

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.

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)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Douglas S. Kim, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-6463
Email: [email protected]

Nicholas Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]

Christine Clarkson
National Institute of Mental Health (NIMH)
Telephone: 301-402-5756
Email: [email protected]

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.

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.