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Grant Analysis

Purpose & Target

GRANT PURPOSE AND TARGET: - To develop new technologies and novel approaches for recording and modulation of neural cells and circuits. - Focus is on addressing major challenges and enabling transformative understanding of dynamic signaling in the central nervous system. - Target recipients: Researchers and organizations involved in neuroscience and technology development. - SECTOR-SPECIFIC - Geographic scope: Global, as non-U.S. entities are eligible. - Key filtering criteria: Focus on technology development for CNS recording/modulation, not biological discovery; clinical trials are not allowed; early-stage, high-risk projects are encouraged. - Grant frequency: Reissue of a previous funding opportunity, indicating recurring nature within the BRAIN Initiative program.

Financial Structure

FINANCIAL STRUCTURE: - Budget range: Application budgets are not limited but must reflect the actual needs of the project. - Total funding amount: Estimated 10,000,000.0 USD per year. - Anticipated number of awards: 15-20 awards per year. - Project period: Maximum 3 years. - Eligible costs: Funds necessary for travel for up to two key personnel to participate in a BRAIN investigator meeting annually (up to two days, two overnight stays). - Ineligible costs: Not specified directly, but typical NIH grant restrictions apply (e.g., salary and fringe benefits for NIH Intramural scientists are not requested in the application if they are involved). - Matching fund requirements: Not required. - Co-financing requirements: Not required. - Payment schedule and mechanisms: Not explicitly detailed in this NOFO, but subject to NIH Grants Policy Statement. - Financial reporting requirements: Recipients must submit annual Research Performance Progress Reports (RPPR) and financial statements as required by NIH Grants Policy Statement. - Audit requirements: Not specified, but standard federal audit requirements apply (e.g., 2 CFR Part 200). - Indirect cost policies: Not specified, but subject to NIH Grants Policy Statement for F&A costs.

Eligibility Requirements

ELIGIBILITY REQUIREMENTS: Eligible Organizations

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
Nonprofits without 501(c)(3) IRS Status
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 Government:
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
Non-domestic (non-U.S.) Entities (Foreign Organizations)

Geographic Requirements

Applicants can be from the U.S. or any non-domestic (non-U.S.) entity.

Project Specifics

Projects must not propose clinical trials.
Preliminary feasibility data are not required for proposed research.
Proposed research must be for technology development for recording/modulation in the nervous system, not primarily for biological discovery or therapeutic outcomes.
Technologies must be compatible with experiments in behaving animals and validated with in vivo experiments.
Focus must be on the Central Nervous System (CNS), not primarily the peripheral nervous system.
Technologies must aim for cellular or circuit resolution for CNS activity.

Registration Requirements

Applicant organizations must complete and maintain active registrations in:
System for Award Management (SAM) (requires annual renewal).
NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations, in lieu of CAGE code).
Unique Entity Identifier (UEI) (issued via SAM.gov registration).
eRA Commons (organization must identify at least one Signing Official and one Program Director/Principal Investigator).
Grants.gov (requires active SAM registration).
Program Directors/Principal Investigators (PD/PIs) must have an eRA Commons account.

Application Process

APPLICATION PRACTICAL INFORMATION: Application Submission

Application Open Date (Earliest Submission Date): May 02, 2025.
Application Due Dates (for New Applications):
June 02, 2025
January 20, 2026
All applications are due by 5:00 PM local time of applicant organization.
Application expiration date: January 21, 2026.
Application forms package must be accessed through:
NIH ASSIST system.
Institutional system-to-system (S2S) solution.
Grants.gov Workspace.
Applicants are encouraged to apply early to allow time for corrections.
Applications are checked for completeness and compliance; incomplete/non-compliant applications will not be reviewed.

Pre-Application Requirements

Letter of Intent (LOI): Recommended 60 days prior to the receipt date, but not required or binding.
LOI should include: Descriptive title, PD/PI name(s), contact info, other key personnel, participating institutions, funding opportunity number and title.
Send LOI to: [email protected].
Prior Consultation: Strongly recommended with Scientific/Research Contact staff (listed in Section VII) preferably before the LOI due date.

Required Documentation and Materials

Follow instructions in the Research (R) Instructions in the 'How to Apply - Application Guide' and any program-specific instructions in this NOFO.
Required forms include:
SF424(R&R) Cover.
SF424(R&R) Project/Performance Site Locations.
SF424(R&R) Other Project Information.
SF424(R&R) Senior/Key Person Profile.
R&R or Modular Budget.
R&R Subaward Budget.
PHS 398 Cover Page Supplement.
PHS 398 Research Plan (including Research Strategy, Resource Sharing Plan, Other Plan(s) for Data Management and Sharing).
PHS Human Subjects and Clinical Trials Information (if human subjects involved, even if not a clinical trial).
PHS Assignment Request Form.
Research Strategy must define the current state-of-the-art and clearly state barriers addressed by the new technology.
Resource Sharing Plans must include: summary of resources, standards for description, archive(s), proposed timeline for sharing, and potential plan for technology transfer/patent capabilities.
Data Management and Sharing Plan is mandatory for all applications and must include: summary of data, standards for description, archive(s), and proposed timelines.
Appendix materials are limited; no publications or other material (except blank questionnaires/surveys) allowed.

Project Implementation and Reporting

Project duration: Maximum 3 years.
Progress tracking: Annual Research Performance Progress Reports (RPPR) are required.
Post-award requirements: A final RPPR, invention statement, and expenditure data portion of the Federal Financial Report are required for closeout.

Support Available

Funding (financial assistance).
Access to NIH staff for consultation.
Post-submission material: One-page update accepted up to 30 days before study section meeting.

Evaluation Criteria

EVALUATION CRITERIA: Overall Impact

Reviewers assess the likelihood of the project exerting a sustained, powerful influence on the research field(s).
An application does not need to be strong in all categories to be judged as having major scientific impact.

Factor 1: Importance of the Research (Significance and Innovation)

Significance:
Extent to which the research addresses an important gap, solves a critical problem, or creates a valuable conceptual/technical advance.
Rationale for the study and rigor of scientific background.
Innovation:
Extent to which the proposed technology represents a major improvement over the current state-of-the-art.
Ability to enable currently infeasible neurobiological experiments or significantly reduce barriers (cost, difficulty, time) to existing experiments.
For high-risk projects, evaluation of commensurate potential for high impact on neuroscience.
Usefulness of project results in informing future phases of development.

Factor 2: Rigor and Feasibility (Approach)

Scientific Quality:
Likelihood of producing unbiased, reproducible, robust data (Rigor).
Soundness and achievability of the proposed approach (Feasibility).
Rigor:
Rigor of experimental design and presence of appropriate controls.
Sufficiency and justification of sample size.
Quality of plans for analysis, interpretation, and reporting.
Adequacy of plans to address relevant biological variables (e.g., sex, age).
Feasibility:
Plans to address problems or new challenges.
For less certain feasibility, balance by potential for major advances.
Adequacy and feasibility of plans for human subjects recruitment and retention (if applicable).
Specific to this NOFO:
Experiments must be formulated to validate the technology and demonstrate its capabilities/potential impact, not to advance biological knowledge.
Proposed proof-of-concept tests must indicate the efficacy and reliability of the technology.

Factor 3: Expertise and Resources (Investigator(s) and Environment)

Investigator(s):
Demonstrated background, training, and expertise appropriate for conducting the proposed work.
Quality of leadership plan for Multiple Principal Investigator (MPI) applications.
Environment:
Appropriateness of institutional resources to ensure successful execution.

Additional Review Criteria (Not Scored, but Considered)

Protections for Human Subjects (if applicable):
Justification for involvement and proposed protections against risks.
Data and safety monitoring for clinical trials (even though clinical trials are not allowed for the primary objective, human subjects research can occur).
Vertebrate Animals (if applicable):
Description of procedures, justification for use, interventions to minimize discomfort, justification for euthanasia.
Biohazards (if applicable):
Assessment of significant hazards and proposed protection.
Authentication of Key Biological and/or Chemical Resources:
Plans for identifying and ensuring validity of resources.
Budget and Period of Support:
Justification and reasonableness in relation to proposed research.

Compliance & Special Requirements

COMPLIANCE AND SPECIAL REQUIREMENTS: Regulatory Compliance

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) is required.
Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Compliance with all federal statutes and regulations relevant to federal financial assistance (highlighted in NIH Grants Policy Statement Section 4).

Data Protection and Sharing

A Data Management and Sharing Plan is required for all applications and must be implemented as described upon approval.
Data sharing expectations for BRAIN Initiative awards are published in NOT-MH-19-010.
A listing of BRAIN Initiative archives is available at braininitiative.nih.gov/brain-programs/informatics.

Ethical Standards

Research involving human subjects requires review by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Recipients must provide NIH copies of documents related to all major changes in the status of ongoing protocols involving human subjects.
Research involving vertebrate animals must adhere to specific criteria for justification, procedures, minimization of discomfort, and euthanasia methods.
Compliance with ethical standards for biohazards is required if applicable.

Intellectual Property

For NIH intramural scientists, intellectual property is managed according to NIH established policy and Executive Order 10096, with patent rights for inventions in NIH facilities being NIH property unless waived.

Risk Management

Applications should propose alternative strategies to mitigate risks of failure, especially for high-risk projects.

Strategic Considerations

Encouraged to integrate multiple approaches and leverage diverse expertise from biological, chemical, physical sciences, engineering, computational modeling, and statistical analysis.
Projects are expected to be early-stage and potentially high-risk, with no preliminary feasibility data required.
Proposed validation experiments must focus on demonstrating technology capabilities and potential impact, not advancing biological knowledge as the primary goal.
Mandatory disclosure of federal criminal law violations involving fraud, bribery, or gratuity affecting the federal award is required (2 CFR 200.113).
NIH reviews an applicant's federal award history in SAM.gov for sound business practices prior to making an award.

Grant Details