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Grant Analysis

Purpose & Target

This grant, part of the NIH BRAIN Initiative, aims to support facilities at Resource-Limited Institutions (RLIs) and Institutional Development Award (IDeA)-eligible institutions for the scaled production and distribution of brain cell type-specific access reagents. The core objective is to broaden the availability of these enabling neurotechnologies to the wider neuroscience community, thereby enhancing research infrastructure at under-resourced institutions. This is a SECTOR-SPECIFIC grant focused on biomedical research, specifically neuroscience and neurotechnologies. The target recipients are diverse U.S.-based organizations that meet the criteria of being an RLI or an IDeA-eligible institution. This funding opportunity is a reissue, indicating a recurring program context within the BRAIN Initiative.

Financial Structure

Funding Mechanism and Amounts This funding is provided as a Cooperative Agreement (U24). The issuing NIH components intend to commit an estimated $2,400,000 total cost per year to fund 2 to 4 awards. While the total budget for the call is specified, application budgets are not limited per individual award but must reflect the actual needs of the proposed project. Matching Fund Requirements No cost sharing or matching funds are required for this NOFO. Eligible Costs Applicants should include the following types of costs in their annual budgets:

Product development, characterization, and testing necessary to maintain a minimal inventory of reagents. This includes purification, formulation, vialing, characterization, evaluation, quality control, quality assurance, and related activities.
Project management effort and personnel for the proposed production and dissemination facilities.
Website/catalogue development and maintenance for disseminating reagents.
Costs for attendance at the anticipated annual in-person consortium meeting.
Travel funds for up to two key personnel to participate in a BRAIN investigator meeting annually (not more than two days, including up to two overnight stays).

Ineligible Costs The following costs are explicitly not to be budgeted for as they are expected to be covered by the neuroscience research users:

Production costs to manufacture reagents beyond the minimal inventory for distribution.
Shipment and delivery costs of reagents to users.

Program Income Applicants are required to describe plans for Program Income, if any, specifically detailing the expected charges to the neuroscience research community for distributing reagents. This implies that revenue generation from reagent distribution is anticipated and should be factored into the financial plan.

Eligibility Requirements

Eligible Organizations To be eligible, an organization must be U.S.-based. Foreign organizations are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. However, foreign components, as defined by NIH, are allowed within an eligible U.S. organization's application. Organizations must fall into one of the following categories, with the overarching goal of enhancing research infrastructure at Resource-Limited Institutions (RLIs) or institutions in IDeA-eligible states:

Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 501(c)(3) IRS Status)
For-Profit Organizations (including Small Businesses and other For-Profits)
Government Entities: Local Governments (County, City/Township, Special District), State Governments, Indian/Native American Tribal Governments (Federally Recognized or Other), Eligible Agencies of the Federal Government (including 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

Specific Qualifications

Resource-Limited Institution (RLI): Defined as an institution that has 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.
IDeA-eligible states: Institutions located in states and jurisdictions identified as IDeA-eligible (those with historically low NIH grant funding success rates), as listed on the NIH NIGMS website.

Exclusion Criteria

Applications proposing clinical trials are explicitly not allowed.
Applications primarily focused on pursuing a biological mechanism or hypothesis through basic research that does not result in a scaled-up reagent production and distribution resource will be considered non-responsive.
Studies primarily focused on technology development that do not propose a scaled-up reagent production and distribution resource are non-responsive (technology development should be integrated into a larger production/distribution project).

Required Registrations All applicant organizations must complete and maintain active registrations with: * System for Award Management (SAM) (requires annual renewal) * Unique Entity Identifier (UEI) (issued via SAM.gov) * eRA Commons (for organization and PD(s)/PI(s)) * Grants.gov Registrations can take 6 weeks or more and must be completed before application submission.

Application Process

Application Submission Dates Applications must be submitted by 5:00 PM local time of the applicant organization on the specified due dates. The latest application due date is June 15, 2027. Other application due dates include: * February 14, 2025 * February 02, 2026 Letter of Intent A letter of intent is not required but is strongly encouraged to be submitted 30 days prior to the application due date. It should include the descriptive title, PD(s)/PI(s) names and contact information, names of other key personnel, participating institutions, and the funding opportunity number. Submission Platforms Applications must be submitted electronically through one of the following platforms: * NIH ASSIST system * An institutional system-to-system (S2S) solution * Grants.gov Workspace Required Documentation and Materials Applicants must follow instructions in the NIH 'How to Apply - Application Guide' with specific supplements from this NOFO. Key components include:

SF424(R&R) Forms: Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile (may include project management personnel), Budget, Subaward Budget.
PHS 398 Forms: Cover Page Supplement, Research Plan, Human Subjects and Clinical Trials Information (if applicable), Assignment Request Form.
Research Plan - Research Strategy: This critical section must detail plans for:
1. Interfacing with at least one Armamentarium reagent design and development project (e.g., recipients of RFA-MH-25-100 or other Armamentarium NOFOs), including how validated designs/templates/seed reagents will be received and how the applicant will interface with partners to improve/optimize reagents and cataloguing.
2. Scaled-up production of designed and validated reagents at an RLI or IDeA-eligible institution, including feasibility, institutional strengths, quality control/assurance, characterization, formulation, evaluation, validation, storage, inventory, and distribution.
3. Disseminating reagents to neuroscience research users, including cataloguing (widely accessible, updated), managing delivery, assessing user demand, incorporating feedback, and creating a user interface website. Plans for managing production/distribution activities (material transfer, licensing, webhosting, cost recovery) and project management efforts.
Proposed Milestones and Timeline: Must be included as part of the Research Strategy, detailing specific milestones and a timeline for achieving the three core functions.
Letters of Support:
- Required: A letter of institutional commitment for each proposed facility at an RLI or IDeA-eligible institution, assuring adequate staff, facilities, and training resources.
- Encouraged: Up to 3 letters from potential end users describing their research plans and the potential impact of the proposed facility.
Program Income: Description of plans for program income, if any, and expected charges for reagents.
Resource Sharing Plan: Compliance with NIH guidelines.
Data Management and Sharing Plan: Required for all BRAIN Initiative NOFOs, describing data to be shared, standards, archives, and timelines (consistent with NOT-MH-19-010).

Post-Award Requirements

Reporting: Annual Research Performance Progress Report (RPPR) and financial statements (Federal Financial Report). A final RPPR, invention statement, and expenditure data are required for closeout.
Data Submission: Recipients are required to submit data to selected BRAIN Initiative data archives every 6 months of the award period.
Consortium Participation: Mandatory participation in the Armamentarium Consortium, involving regular meetings and sharing of technologies, reagents, and data.
Substantial NIH Involvement: As a Cooperative Agreement, NIH staff will assist, guide, coordinate, or participate in project activities, with recipients retaining primary responsibility.

Evaluation Criteria

Applications will be evaluated for scientific and technical merit through the NIH peer review system, ultimately receiving an Overall Impact score based on the likelihood of the project exerting a sustained, powerful influence on the research field. Scored Review Criteria Reviewers will provide separate scores for each of the following:

Significance: Does the project address an important problem or critical barrier to progress in the field? How will it improve scientific knowledge, technical capabilities, or clinical practice? Will it broaden distribution of enabling technologies?
Investigator(s): Are the PD(s)/PI(s) well-suited for the project? Do they have the appropriate experience, training, and a demonstrated record of accomplishment?
Innovation: Does the project challenge existing paradigms, develop new methodologies, or use novel approaches? (Note: For this specific NOFO, mature and well-established approaches that produce robust, high-quality reagents for broad use are acceptable and may not be innovative per se).
Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims? Are potential problems and alternative strategies addressed? Is there a robust plan for the three required resource functions (interfacing with Armamentarium, scaled production, dissemination)?
Environment: Will the institutional environment contribute to the probability of success in facilitating the research projects? Are institutional support, equipment, and resources adequate? Specifically, will the environment enable scalable production and dissemination of reagent resources, and promote brain cell type-selective reagent production infrastructure at an RLI and/or IDeA-eligible institution? Is the institutional commitment described in the required Letters of Support sufficient?

Additional Review Criteria (Not Individually Scored) Reviewers will consider these factors when determining scientific and technical merit and the overall impact score:

Study Timeline: Appropriateness of the proposed milestones and timeline.
Protections for Human Subjects (if applicable): Justification for involvement and proposed protections.
Inclusion of Women, Minorities, and Individuals Across the Lifespan (if applicable): Proposed plans for inclusion/exclusion.
Vertebrate Animals (if applicable): Description of procedures, justification, and humane care.
Biohazards (if applicable): Assessment of potential hazards and proposed protections.
Resubmissions/Renewals/Revisions: Evaluation of responses to previous reviews and changes made (for resubmissions), progress made (for renewals), or appropriateness of proposed expansion (for revisions).
Resource Sharing Plans: Reasonableness of plans or rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity.
Budget and Period of Support: Justification and reasonableness of the budget in relation to the proposed work.

Compliance & Special Requirements

Regulatory and Administrative Compliance All awards are subject to the terms and conditions described in the NIH Grants Policy Statement, including:

Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR Part 200).
Nondiscrimination Laws: Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Federal Statutes and Regulations: Adherence to all federal statutes and regulations relevant to federal financial assistance.
Mandatory Disclosures: Recipients must report any violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award.

Data Protection and Sharing

NIH Policy for Data Management and Sharing: Required for all research generating scientific data.
BRAIN Initiative Data Sharing Policy (NOT-MH-19-010): Establishes expectations for data sharing. Plans must include a summary of data, description of standards, archives, and proposed timelines for submission and sharing.
Regular Data Submission: Data must be submitted to selected BRAIN Initiative data archives every 6 months of the award period. Data will be held privately until publication or end of award, whichever is sooner.

Intellectual Property (IP) Policies

Recipients retain custody and primary rights to data and resources developed, subject to Government rights of access.
Patent Rights: For inventions developed in NIH facilities, patent rights are NIH property unless waived.

Ethical Standards and Safeguards

Human Subjects Protection (if applicable): Compliance with 45 CFR Part 46. Protocols must be reviewed by the recipient's IRB or IEC.
Vertebrate Animal Care (if applicable): Compliance with ethical guidelines for animal use.
Biohazards: Proposed protections against materials or procedures potentially hazardous to research personnel and/or the environment will be assessed.

Special Considerations and Requirements

Cooperative Agreement (U24): This funding instrument signifies substantial Federal scientific or programmatic involvement from NIH staff (Program Officers, Project Scientists, Project Teams) in assisting, guiding, coordinating, and participating in project activities. While NIH is involved, the recipient retains the dominant role and prime responsibility for the project.
Armamentarium Consortium: Successful applicants must participate as voting members in the Armamentarium Consortium Steering Group, which includes other award recipients from various BRAIN Initiative NOFOs, NIH staff, and external experts. This involves regular meetings and the sharing of protocols, technologies, reagents, and data among consortium members.
Resource-Limited Focus: The NOFO specifically aims to enhance research infrastructure at Resource-Limited Institutions (RLIs) and IDeA-eligible institutions, promoting advanced technology integration and research capacity development in these areas.
Clinical Trial Exclusion: This grant is strictly for non-clinical trial research.
Program Income: Applicants are expected to describe plans for generating program income through charges for distributed reagents.
Dispute Resolution: A specific dispute resolution procedure is outlined for disagreements between recipients and NIH on scientific or programmatic matters, not altering the right to appeal adverse actions.

Grant Details