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Grant Analysis

Purpose & Target

- - Core objective: To support facilities that will scale up the production and distribution of brain cell type-specific access reagents. This enables neuroscientists to study circuit function with high precision in experimental animals and ex vivo human tissue and cells. - Target recipient type and size: Organizations of various types and sizes, including higher education institutions, non-profits, for-profit businesses (small and large), and government entities, that can establish and operate such production and distribution facilities. - SECTOR-SPECIFIC - Geographic scope: Domestic U.S. organizations only. Foreign organizations are not eligible. - Key filtering criteria: Applicant must propose a facility for scaled production and distribution of specific brain cell type-specific access reagents, interface with existing Reagent Resource for Design and Development (RRDD) projects, coordinate data distribution, and be willing to participate in a research consortium. Clinical trials are not allowed. - Grant frequency: This is part of the ongoing BRAIN Initiative Armamentarium project, implying a recurring program context.

Financial Structure

Budget: Issuing components intend to commit an estimated total of $2,400,000 per year to fund 2 to 4 awards.
Award Budget: Application budgets are not limited but must reflect the actual needs of the proposed project.
Project Period: The maximum project period is 5 years.
Cost Sharing: Not required.
Eligible Costs:
Costs for product development, characterization, and testing to maintain a minimal inventory of reagents (including purification, formulation, vialing, characterization, evaluation, quality control, quality assurance).
Costs for project management and website/catalogue development and maintenance.
Costs for attendance at the anticipated annual in-person meeting for the research consortium.
Necessary funds for collecting and submitting Common Data Elements (CDEs) for mental health human subjects research to the NIMH Data Archive (NDA).
Ineligible Costs:
Production costs to manufacture reagents beyond the minimal inventory for distribution (neuroscience research users are required to pay for these).
Shipment and delivery of reagents (neuroscience research users are required to pay for these).
Program Income: Applicants should describe plans for any program income, including expected charges to the neuroscience research community for distributing reagents.
Funding Mechanism: Cooperative Agreement (U24), indicating substantial Federal scientific or programmatic involvement.

Eligibility Requirements

Organizational Type

Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 501(c)(3) IRS Status)
For-Profit Organizations (Small Businesses, Other For-Profit Organizations)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal)
Federal Government (Eligible Agencies, including NIH Intramural Program)
U.S. Territory or Possession entities
Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations.

Geographic Location

Must be a domestic (U.S.) entity. Foreign organizations or non-domestic components of U.S. organizations are not eligible.

Registrations

System for Award Management (SAM) with active registration (annual renewal required).
Unique Entity Identifier (UEI) obtained through SAM.gov.
eRA Commons account for the organization and for all Program Director(s)/Principal Investigator(s) (PD/PIs).
Grants.gov registration (requires active SAM registration).

Project Requirements

Applications must propose to address all four main functions of a Production and Distribution Facility (PDF):
Interfacing with one or more Armamentarium Reagent Resource for Design and Development (RRDD) projects (specifically those funded under RFA-MH-25-100).
Scaled-up production of RRDD-validated reagents.
Disseminating reagents broadly to neuroscience research users.
Coordinating RRDD reagent data and metadata distribution to BRAIN Initiative data archives and consortium members.
Applications must include proposed milestones and a proposed timeline.
Clinical trials are not allowed.
The proposed project must not be 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 facility.
The proposed project must not be primarily focused on technology development that does not propose a scalable reagent resource.

Application Process

Letter of Intent (LOI): Not required but encouraged. Due 30 days prior to the application due date(s). Should include descriptive title, PD(s)/PI(s) details, key personnel, participating institutions, and NOFO number/title.
Application Submission: Must be submitted electronically through NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Page Limitations: Strict adherence to all page limitations described in the "How to Apply – Application Guide" and the "Table of Page Limits" is required.
Multiple Applications: Applicant organizations may submit more than one application, provided each is scientifically distinct. Duplicate or highly overlapping applications will not be accepted.

Key Dates

Open Date (Earliest Submission Date): September 30, 2025
Application Due Dates (by 5:00 PM local time of applicant organization):
For earliest start July 2026: October 31, 2025
For earliest start April 2027: July 01, 2026
Expiration Date: July 02, 2026.

Required Documentation

Standard Federal forms: SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile.
Budget forms: R&R Budget and R&R Subaward Budget (if applicable), detailing eligible costs and excluding ineligible ones.
PHS 398 Cover Page Supplement.
PHS 398 Research Plan: Must include a detailed Research Strategy addressing the four core functions of a PDF (interfacing with RRDDs, scaled production, dissemination, data coordination).
Proposed Milestones and Timeline: Mandatory, must explain critical indicators of progress, be feasible, well-developed, and quantifiable.
Letters of Support: Encouraged from potential facility users (maximum 5 letters). Institutional letters describing financial/collaborative arrangements or third-party interest are also allowed.
Program Income plans: Description of any expected charges to neuroscience research community for reagent distribution.
Resource Sharing Plan: Detailed plan for broad sharing of resources (e.g., model organisms, reagents), including management, description, schedule, access, and post-award disposition.
Data Management and Sharing Plan: Mandatory for all applications generating scientific data, requiring deposition in BRAIN Initiative data archives (specifically NIMH Data Archive - NDA). Semi-annual submission for descriptive/raw data (Jan 15, July 15); other data at publication or grant end.
PHS Human Subjects and Clinical Trials Information (if human subjects are involved; clinical trials are not allowed).
PHS Assignment Request Form.

Post-Award Reporting

Research Performance Progress Report (RPPR) annually.
Financial statements as required.
Final RPPR, invention statement, and expenditure data for closeout.
Federal Subaward Reporting System (FSRS) for subawards over $25,000.
System for Award Management (SAM) reporting for civil, criminal, and administrative proceedings.

Application Assistance

Contacts provided for eRA Service Desk, General Grants Information, Grants.gov Customer Support, Scientific/Research, Peer Review, and Financial/Grants Management inquiries.

Evaluation Criteria

Overall Impact

Likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.

Significance

How well the proposed Resource addresses the needs of the research projects it will serve.
Appropriateness of the scope of proposed activities.
Potential for successful completion to bring unique advantages or capabilities.
Significance for disseminating brain cell type-selective access reagents to neuroscience researchers.
Value added over comparable facilities (assessed from letters of support).
Relevance of the proposed scale of reagent dissemination.
Usefulness of planned user interfaces for reagent distribution.
Value of proposed data coordination efforts for the facility.

Investigator(s)

Suitability and experience of PD(s)/PI(s) and other personnel for their roles.
Demonstrated experience in managing cell type-selective reagent research.
Significant experience with coordinating collaborative basic research.
For multi-PD/PI projects: complementary expertise, leadership approach, governance, conflict resolution, organizational structure appropriateness.
Experience overseeing subawards.
Demonstrated experience and expertise in scalable production and dissemination of reagent resources.

Innovation

Novelty of organizational concepts, management strategies, or methods.
Integration of existing approaches in novel ways.
Cutting-edge methods for scaling up reagent production, quality control/assurance, characterization, inventory management, and/or distribution.
Novelty in cataloguing reagent inventory and/or receiving user feedback.
Novelty of plans for data coordination efforts.

Approach

Overall strategy, operational plan, and organizational structure are well-reasoned and appropriate to accomplish project goals.
Strategies to ensure a robust and unbiased scientific approach.
Presentation of potential problems, alternative strategies, and benchmarks for success.
Adequacy of strategy to establish feasibility and manage risks (for early-stage operations).
Appropriateness of workflow and timeline.
Plans for considering relevant biological variables (e.g., sex) for studies involving vertebrate animals or human subjects.
Appropriateness of plans to interface with Armamentarium RRDD project investigators.
Feasibility of plans to conduct scaled-up production of designed and validated reagents.
Effectiveness of proposed facility in disseminating reagents.
Soundness of plans to coordinate reagent data distribution.

Environment

Contribution of the institutional environment to the probability of success.
Adequacy of institutional support, equipment, and physical resources.
Benefit from unique features of the institutional environment, infrastructure, or personnel.
Availability of resources for electronic information handling.
Extent to which the environment enables scalable production and dissemination of reagent resources.

Milestones and Timeline

Proposed Milestones and Timeline are described in sufficient detail, appropriate for the project, reasonable, feasible, well-developed, and quantifiable with regard to specific aims.

Compliance & Special Requirements

Regulatory Compliance

Adherence to NIH Grants Policy Statement, U.S. Office of Management and Budget (OMB) administrative guidelines, and U.S. Department of Health and Human Services (HHS) grant administration regulations (2 CFR Part 200).
Compliance with all applicable nondiscrimination laws (applicants agree to this upon SAM.gov registration and submission of HHS-690 Assurance of Compliance).
Federal Awardee Performance and Integrity Information System (FAPIIS) requirements apply.
Mandatory compliance with the NIH Data Management and Sharing Policy, requiring data deposition to relevant BRAIN Initiative data archives (specifically the National Institute of Mental Health Data Archive (NDA)).
If research involves human subjects, compliance with 45 CFR Part 46 and specific human subjects protection guidelines is required (though clinical trials are not allowed).
If research involves vertebrate animals, detailed procedures, justifications for species choice, and plans for minimizing discomfort/pain are required.
Assessment of biohazards and proposed adequate protections.

Cooperative Agreement Terms

Substantial NIH programmatic involvement is anticipated; NIH staff will assist, guide, coordinate, or participate in project activities.
Recipients retain the dominant role and prime responsibility for the project.
Recipients must:
Scale up production and distribution of brain cell type-selective access reagents for the neuroscience field.
Determine and coordinate research approaches, conduct experiments, and analyze/interpret research data.
Meet or exceed the timeline stated in their application.
Participate as a voting member in a Consortium Steering Group (comprised of other Armamentarium recipients, NIH staff, and external experts).
Share protocols, technologies, reagents, and data with consortium members.
Not disclose confidential information obtained from other consortium members.
Ensure timely publication of results and coordinate publication, reagent, and data dissemination with the consortium.
Submit protocols, reagents, and data for quality assessment/validation as specified by the Steering Group or NIH Project Scientist.
Submit annual milestone reports with complete experimental design rigor and results.
Accept and implement common guidelines and procedures approved by the Steering Group.
Attend Steering Group meetings (likely annual in-person, others via videoconference).
Recipients retain custody and primary rights to data and resources developed, subject to Government access rights.

Research Exclusions

Applications will be considered non-responsive and will not be reviewed if they:
Fail to address all four core functions of a PDF (interfacing with RRDDs, scaled production, dissemination, data coordination).
Fail to include proposed milestones and a proposed timeline.
Are primarily focused on basic biological mechanism/hypothesis research that does not result in a scaled-up reagent production and distribution facility.
Are primarily focused on technology development that does not propose a scalable reagent resource.

Intellectual Property

Managed in accordance with NIH established policy and Executive Order 10096. Patent rights for inventions developed in NIH facilities are NIH property unless waived.

Data Standards and Resource Identification

Encouraged to use Common Data Elements (CDEs) in human subjects research to facilitate data sharing and standardization. Specifically, NIMH expects collection of mental health CDEs for human subjects research and submission to the NIMH Data Archive (NDA).
Investigators are strongly encouraged to obtain a research resource ID from the Resource Identification Initiative (https://scicrunch.org/resources/about/resource) and use Resource IDs in publications.

Foreign Components

While foreign organizations are not eligible to apply directly, foreign components (as defined in the NIH Grants Policy Statement) of eligible U.S. organizations are allowed.

Grant Details