This BRAIN Initiative Notice of Funding Opportunity (NOFO) is to support scaled reagent production and distribution facilities involving technologies to access brain cell types. Facilities for production and distribution of these reagents by a broad set of neuroscientists will be encouraged. This NOFO is part of the BRAIN Initiative Armamentarium for Brain Cell Access transformative project. Efforts will be supported to produce and distribute gene transfer, gene regulation, and genome engineering reagents for use in both genetically tractable and less tractable systems, including primates and human tissue, which are relevant for future translational efforts. Reagents to be produced and distributed are those designed and validated under other NOFOs from the Armamentarium transformative project.

Funding Opportunity Number: RFA-MH-25-105. Assistance Listing: 93.173,93.213,93.242,93.273,93.279,93.286,93.853,93.865,93.866,93.867. Funding Instrument: CA. Category: ED,HL,ISS.

RFA-MH-26-120: BRAIN Initiative: Reagent Resources for Brain Cell Type-Specific Access to Broaden Distribution of Enabling Technologies for Neuroscience (U24 Clinical Trial Not Allowed) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Mental Health ( NIMH ) National Eye Institute ( NEI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute on Drug Abuse ( NIDA ) National Institute of Neurological Disorders and National Center for Complementary and Integrative Health ( NCCIH ) Funding Opportunity Title BRAIN Initiative: Reagent Resources for Brain Cell Type-Specific Access to Broaden Distribution of Enabling Technologies for Neuroscience (U24 Clinical Trial Not Allowed) U24 Resource-Related Research Projects – Cooperative Agreements March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) 93. 242, 93.

853, 93. 286, 93. 865, 93.

213, 93. 279, 93. 173, 93.

866, 93. 273, 93. 867 Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) from the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is intended to support facilities at Resource-Limited Institutions (RLIs) and Institutional Development Award (IDeA)-eligible institutions for scaled production and distribution of brain cell type-specific access reagents.

The reagents to be distributed will first be developed in separately supported reagent design and development projects for brain cell type-specific access across vertebrate species in the BRAIN Initiative Armamentarium project. Recipients of awards under this NOFO will then work with these Armamentarium projects to manufacture and distribute the reagents for use throughout the neuroscience community.

It is envisioned that the recipients will work both with Armamentarium researchers as well as with the neuroscience research community to optimize the new reagents. The types of reagents to be produced and distributed could include but are not limited to viral vectors, nucleic acid constructs, and nanoparticles designed for selective access to brain cell types.

Such reagents will enable neuroscientists to probe circuit function with high precision in experimental animals and ex vivo human tissue and cells. Facilities are needed to contribute to the production and distribution of BRAIN Initiative Armamentarium project reagents broadly to neuroscience users.

This NOFO is part of the BRAIN Initiative Armamentarium project, whose overall goal is to generate tools to specifically access, manipulate, and monitor brain cell types across multiple vertebrate species. This NOFO will foster close interaction between technologists, disseminators, and neurobiologists in a research consortium including investigators funded by other Armamentarium NOFOs.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Since 2014, the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative has aimed to accelerate the development and application of innovative neurotechnologies, enabling researchers to produce a new dynamic picture of the brain that reveals how individual cells and complex neural circuits interact in both time and space.

It is expected that these advances will ultimately lead to new ways to treat and prevent brain disorders. The NIH 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. 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.

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.

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.

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.

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.

Section II. Award Information Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

See Section VI. 2 for additional information about the substantial involvement for this NOFO. Application Types Allowed The OER Glossary and the How to Apply - Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards Issuing IC and partner components intend to commit an estimated $2,400,000 total cost per year to fund 2 to 4 awards. Application budgets are not limited but need to reflect the actual needs of the proposed project. The maximum project period is 5 years.

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

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government- Including the NIH Intramural Program U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations The overarching goal of this program is to enhance the research infrastructure at the following BRAIN Initiative research area institutions: 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, 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 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 . 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 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. All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed. Applicants may include project management personnel for the proposed facilities for the production and dissemination of reagents as Senior/Key Person(s). 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. 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.

All instructions in the How to Apply - Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 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