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Grant Details

https://www.grants.gov/search-results-detail/357137

Grant Analysis

Purpose & Target

The core objective of this BRAIN Initiative grant is to encourage research that will develop and validate novel tools to facilitate the detailed analysis of complex neural circuits and provide insights into cellular interactions underlying brain function. - Target recipients include a wide range of organizations: higher education institutions, nonprofits, for-profit businesses (small and large), and various governmental entities. - This grant is SECTOR-SPECIFIC, focusing on neuroscience, neurotechnologies, and brain research. - Geographic scope covers organizations within the United States and non-U.S. (foreign) entities. - Key filtering criteria for initial screening are that applications must focus on 'tool/technology development' rather than primarily pursuing a biological/disease mechanism or hypothesis, and clinical trials are explicitly 'not allowed'. - This grant opportunity is recurring, with multiple application due dates until its expiration in February 2027, indicating it's part of an ongoing program context.

Financial Structure

  • Total estimated funding commitment for this opportunity is $8000000.0.
  • The anticipated number of awards ranges from 6-9.
  • Application budgets are 'not limited', but must 'reflect the actual needs' of the proposed project.
  • The maximum project period allowed is 3 years.
  • Cost sharing as defined by NIH Grants Policy Statement Section 1.2 is not required for this NOFO.
  • Pre-award costs are allowable as described in the NIH Grants Policy Statement Section 7.9.1.
  • The currency for funding is USD.

Eligibility Requirements

Organization Type
  • Eligible organizations include:
  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education
  • Nonprofits with 501(c)(3) IRS Status
  • Nonprofits without 501(c)(3) IRS Status
  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)
  • 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)
  • Eligible Agencies of the Federal Government (including NIH Intramural Programs)
  • 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
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Organizations)
Geographic Location
  • Organizations located in the United States and foreign organizations are eligible to apply.
Technical Qualifications
  • Proposed projects must specifically focus on the 'development and validation of novel tools' to probe cell-specific and circuit-specific processes in the brain.
  • Applications must include clear plans for validating the utility of the developed tool or technology.
  • Preference is given to tools that can be used in a number of species/model organisms rather than those restricted to a single species.
  • Projects involving 'clinical trials' are explicitly not allowed.
Registration Requirements
  • Applicant organizations must complete and maintain active registrations with the following:
  • System for Award Management (SAM) - requires annual renewal.
  • NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations, in lieu of a CAGE code).
  • Unique Entity Identifier (UEI) - issued as part of SAM.gov registration.
  • eRA Commons - organizations must register with at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
  • Grants.gov - requires an active SAM registration.
  • All required registrations must be completed prior to submitting the application; the registration process can take six weeks or more.
  • All PD(s)/PI(s) must have an eRA Commons account and include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form.
Exclusion Criteria
  • Applications primarily focused on the pursuit of a biological/disease mechanism or a hypothesis, rather than tool/technology development, will be considered non-responsive and will not be reviewed.

Application Process

Application Deadlines
  • A Letter of Intent (LOI) is not required, not binding, and does not affect review. However, prospective applicants are encouraged to submit an LOI 30 days prior to the application due date.
  • Application due dates are structured in multiple cycles, with the latest possible submission date being 2027-02-08 17:00:00-05:00 (5:00 PM local time of applicant organization).
  • The expiration date for this funding opportunity is 2027-02-09.
Submission Method
  • 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 Content
  • Applicants must strictly follow the instructions in the Research (R) Instructions in the 'How to Apply - Application Guide' and any program-specific instructions outlined in this NOFO.
  • Key components of the application include:
  • SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile).
  • R&R or Modular Budget (and Subaward Budget if applicable).
  • PHS 398 Cover Page Supplement.
  • PHS 398 Research Plan, which must include:
    • Research Strategy: Required to detail specific proof-of-concept tests for the proposed tool, alternative strategies if performance fails, and how results will inform future tool development (e.g., testing in other model systems or human brain).
    • Current State-of-the-Art Statement: Define the current benchmark technology and provide a rationale for why the proposed technology is superior and likely to have a high impact.
    • Milestones: A distinct final section within the Research Strategy proposing concrete indicators of progress at critical junctures.
  • Resource Sharing Plan: Required, detailing specific resources to be shared (e.g., model organisms, reagents, tools), proposed archives, timelines for submission/sharing, and potential plans for technology transfer/patent. Must meet BRAIN Initiative expectations (NOT-MH-19-010).
  • Data Management and Sharing Plan: Required, summarizing data to be shared, standards, archives, and timelines.
  • Only limited Appendix materials are allowed (e.g., blank questionnaires, surveys; no publications).
Post-Award Requirements
  • Recipients are required to submit the Research Performance Progress Report (RPPR) annually and financial statements as per NIH Grants Policy Statement Section 8.4.1.
  • A final RPPR, invention statement, and expenditure data are required for award closeout.
Application Assistance
  • For system-related questions (ASSIST, eRA Commons, errors), contact the eRA Service Desk.
  • For general application instructions and resources, contact NIH General Grants Information.
  • For Grants.gov registration and Workspace issues, contact Grants.gov Customer Support.
  • Specific contacts for Scientific/Research, Peer Review, and Financial/Grants Management inquiries are provided in Section VII of the NOFO.

Evaluation Criteria

Reviewers will provide an 'overall impact score' based on the likelihood of the project to exert a sustained, powerful influence on the research field. Scored Review Criteria
  • Importance of the Research (Significance and Innovation): This assesses the significance of the problem addressed, potential to improve scientific knowledge, and the novelty of concepts, approaches, or technologies proposed.
  • Rigor and Feasibility (Approach): Evaluates the soundness of strategies, methodology, and analyses. For 'early-stage and high-risk' projects, preliminary data on feasibility is not required, but a strong rationale is needed regarding why the proposed approach is most appropriate and likely to achieve high impact.
  • Expertise and Resources (Investigator(s) and Environment): Considers the qualifications of the investigators, appropriateness of the team's expertise, and the suitability of the research environment for successful project execution.
Additional Review Criteria (not scored, but contribute to overall impact)
  • Protections for Human Subjects (if applicable).
  • Vertebrate Animals (if applicable).
  • Biohazards (if applicable).
  • Resubmissions, Renewals, Revisions: Evaluation based on the applicant's response to previous reviews.
  • Milestones and Timeline: Specific, concrete indicators of progress at critical junctures must be included within the Research Strategy.
Additional Review Considerations (not scored)
  • Authentication of Key Biological and/or Chemical Resources.
  • Budget and Period of Support: Assessment of whether the requested budget and project duration are fully justified and reasonable in relation to the proposed research.
Strategic Priorities
  • Projects that propose to generate transformative tools widely usable across the research community are highly encouraged.
  • Preference for 'first-in-class' and/or cross-cutting non-invasive or minimally invasive techniques that permit repeated, non-destructive measurements.
  • Strong encouragement for approaches that break through existing technical barriers to substantially improve current capabilities.
  • Collaboration between biological scientists and experts in fields like nanobiology, materials science, and engineering is encouraged.

Compliance & 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.
  • Recipients must comply with applicable nondiscrimination laws, agreed upon during SAM.gov registration, and submit an Assurance of Compliance (HHS-690).
  • Compliance with all federal statutes and regulations relevant to federal financial assistance is required.
  • If the award involves implementing, acquiring, or upgrading health IT, recipients must use health IT that meets standards in 45 CFR part 170, Subpart B, and is certified under the ONC Health IT Certification Program (if applicable).
  • For recipients with access to HHS systems or PII/PHI, plans and procedures modeled after the NIST Cybersecurity framework must be developed.
  • Mandatory disclosure of violations of federal criminal law involving fraud, bribery, or gratuity affecting the federal award is required (2 CFR 200.113).
Data Management and Sharing
  • Recipients are required to adhere to the 2023 NIH Policy for Data Management and Sharing.
  • An approved Data Management and Sharing Plan must be implemented as described.
Ethical Standards
  • Protocols involving human subjects must be reviewed by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
  • Data sharing expectations are aligned with the BRAIN Initiative (NOT-MH-19-010).
Intellectual Property
  • Intellectual property for inventions developed in NIH facilities is managed according to NIH policy (Executive Order 10096, 45 CFR Part 7), with patent rights generally belonging to NIH unless waived.
  • The Resource Sharing Plan should include a potential plan for technology transfer and/or patent capabilities of the developed resources.
Risk Management
  • Projects are acknowledged as 'early-stage and potentially high-risk', and applications must detail specific proof-of-concept tests and alternative strategies to mitigate these risks.
Other Requirements
  • Awardees are expected to cooperate and coordinate activities after awards are made, including participating in Program Director/Principal Investigator (PD/PI) meetings and the annual PI meeting.
  • NIH will review an applicant's federal award history in SAM.gov to ensure sound business practices prior to making an award.

Grant Details

brain initiative neuroscience neurotechnology tool development r01 grant nih national institutes of health mental health neurological disorders biomedical imaging child health deafness communication disorders drug abuse aging eye alcohol abuse complementary medicine integrative health research and development innovation cellular processes circuit processes high-risk research proof of concept technology validation genetic tools non-genetic tools cell-type specific circuit-specific in-situ analysis non-invasive techniques minimally invasive techniques multiplex analysis high-throughput screening computational approaches data sharing resource sharing us government grant
BRAIN Initiative: Development and Validation of Novel Tools to Probe Cell-Specific and Circuit-Specific Processes in the Brain (R01 Clinical Trial Not Allowed)
RFA-MH-26-170
BRAIN Initiative
UNIVERSITY NGO SME ENTERPRISE PUBLIC OTHER
US AF AL DZ AS AD AO AI AQ AG AR AU AT BY BE BA BR BG CA CN HR CY CZ DK EG EE FI FR GE DE GI GR HU IS IN IE IL IT JP LV LI LT LU MK MY MT MX MD ME NL NZ NO PL PT QA RO SA RS SC SG SK SI KR ES SE CH TW TR UA AE UK VA VG VI
HEALTHCARE TECHNOLOGY
DEVELOPMENT IDEA
OTHER
SDG3 SDG9
FUNDING RESEARCH_DEVELOPMENT
False
8000000.00
None
None
USD
None
Feb. 8, 2027, 10 p.m.
July 2027 - October 2027