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Grant Analysis

Purpose & Target

The core objective is to stimulate basic technology-focused research to develop next-generation human cell-derived Microphysiological Systems (MPS) and related assays.
These systems must replicate complex nervous system architectures and physiology with improved fidelity, enabling future studies of development, function, and aging in healthy and disease states.
Target recipients are research organizations capable of conducting exploratory/developmental biomedical and biobehavioral research.
This grant is SECTOR-SPECIFIC, focusing on the health and technology sectors, specifically neurobiology and bioengineering.
Geographic scope includes organizations within the United States and non-U.S. (foreign) entities globally.
Key filtering criteria for initial screening: must be focused on MPS technology development for nervous system research, not clinical trials, and not solely focused on compound screening or cell therapy.

Financial Structure

Maximum funding: $275,000 for the combined two-year project period.
No more than $200,000 may be requested in any single year.
The total project period may not exceed 2 years.
No cost sharing is required for this funding opportunity.
All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
Financial reporting requires submission of financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting, and an expenditure data portion of the Federal Financial Report for closeout.

Eligibility Requirements

Organizational Eligibility

Eligible types: Higher Education Institutions (Public/State Controlled, Private), Nonprofits (with or without 501(c)(3) IRS Status), For-Profit Organizations (Small Businesses, Other than Small Businesses), Local Governments, State Governments, County Governments, City or Township Governments, Special District Governments, Indian/Native American Tribal Governments (Federally Recognized or Other), Federal Government Agencies, U.S. Territories or Possessions, 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, and Non-domestic (non-U.S.) Entities (Foreign Organizations).

Registration Requirements

Applicant organizations must complete and maintain active registrations prior to application submission:
- System for Award Management (SAM) - requires annual renewal.
- NATO Commercial and Government Entity (NCAGE) Code - required for foreign organizations (in lieu of CAGE code).
- Unique Entity Identifier (UEI) - issued as part of SAM.gov registration.
- eRA Commons - organizations must register with eRA Commons, identifying at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
- Grants.gov - requires active SAM registration.
Program Directors/Principal Investigators (PD/PIs) must have an eRA Commons account, affiliated with the applicant organization.

Project Specifics

Projects must not propose clinical trials.
Preliminary data is not required for R21 applications but may be included if available.
Applications may submit more than one application, provided each is scientifically distinct.

Application Process

Application Deadlines

Applications are due by 5:00 PM local time of the applicant organization on the following dates:
- February 16, 2025
- June 16, 2025
- October 16, 2025 (latest)
If a submission date falls on a weekend or federal holiday, the deadline is automatically extended to the next business day.

Submission Process

Applications must be submitted electronically through one of the following methods:
- NIH ASSIST system.
- Institutional system-to-system (S2S) solution.
- Grants.gov Workspace.
Required registrations (SAM, UEI, NCAGE for foreign, eRA Commons, Grants.gov) must be completed before the application due date.
Applicants are encouraged to submit early to allow time for corrections.
Applications will be evaluated for completeness and compliance; incomplete or non-compliant applications will not be reviewed.

Required Documentation and Materials

Follow instructions in the Research (R) Instructions in the 'How to Apply - Application Guide', supplemented by this NOFO.
All page limitations described in the 'How to Apply - Application Guide' and 'Table of Page Limits' must be followed.
Required forms include: SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile.
Budget forms: R&R or Modular Budget, R&R Subaward Budget.
PHS forms: 398 Cover Page Supplement, 398 Research Plan, Human Subjects and Clinical Trials Information, Assignment Request Form.
Research Strategy: Must focus on technical improvements and capabilities of human cell-based MPS relative to the current state-of-the-art. Genetic or environmental perturbations for assay validation are optional.
Resource Sharing Plan: Required.
Data Management and Sharing Plan: Required for all research generating scientific data, regardless of direct costs. Protocols for generating and validating assays must be disseminated.
Appendix: Limited materials allowed (no publications, only blank questionnaires/surveys).

Post-Award Reporting and Compliance

Recipients are required to submit the Research Performance Progress Report (RPPR) annually.
Data generated under this NOFO is expected to be shared via the National Institute of Mental Health Data Archive (NDA) semi-annually (January 15 and July 15) for descriptive/raw data, and at publication or end of grant for other data.
Resources developed should be registered in the Neuroscience Information Framework (SciCrunch) using Research Resource Identifiers (RRID) in publications.

Evaluation Criteria

Applications are evaluated for scientific and technical merit through NIH's peer review system, with an emphasis on novel scientific ideas and significant impact. Scored Review Criteria Reviewers will provide an overall impact score based on the following three factors, with separate scores for Factors 1 and 2: - Factor 1. Importance of the Research (Significance and Innovation): Assesses the potential for the project to exert a sustained, powerful influence on the research field. Projects should exploit novel tools or technologies, address intransigent barriers or substantially exceed the state-of-the-art in cellular maturation and integration, and aim to improve assay fidelity to in vivo neural circuit structure/function. - Factor 2. Rigor and Feasibility (Approach): Evaluates the soundness of the research plan and methodology. - Factor 3. Expertise and Resources (Investigator(s) and Environment): Assesses the qualifications of the investigator(s) and the adequacy of institutional resources. Specifically, projects should engage expert collaborators (e.g., developmental neurobiology, stem cell biology, circuit and systems level neuroscience, materials science, engineering, bioethics) appropriate for the assay optimization needs. Additional Review Criteria (Considered, but not scored)

Protections for Human Subjects: Evaluation of justification for involvement and proposed protections, if applicable.
Vertebrate Animals: Evaluation of justification for use, interventions to minimize discomfort, and euthanasia methods, if applicable.
Biohazards: Evaluation of proposed protection measures, if applicable.
Resubmissions/Renewals/Revisions: Assessment of previous application's progress or scope expansion, if applicable.

Additional Review Considerations (Considered, but not scored or impacting overall score)

Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity.
Budget and Period of Support: Justification and reasonableness of the requested budget.

Compliance & Special Requirements

Regulatory Compliance

Awards are subject to: Public Health Service Act (Sections 301 and 405), Federal Regulations 42 CFR Part 52 and 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Recipients must comply with all applicable non-discrimination laws and submit an Assurance of Compliance (HHS-690).
Compliance with federal statutes and regulations relevant to federal financial assistance is required.

Data Protection and Cybersecurity

If funding involves health IT implementation/upgrade, recipients must use health IT meeting 45 CFR part 170, Subpart B standards.
If funding involves health IT for eligible clinicians, use ONC Health IT Certified Program technology.
For entities with ongoing access to HHS systems/data (including PII/PHI), plans and procedures modeled after the NIST Cybersecurity framework are required.

Ethical and Research Standards

No Clinical Trials Allowed: Applications proposing clinical trials are not accepted.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for human subjects research.
Protocols involving vertebrate animals must adhere to specific guidelines for animal welfare.
Biohazards must be adequately protected against.

Intellectual Property and Data Sharing

Resource sharing plans and data management and sharing plans are mandatory.
Investigators are expected to register resources in the Neuroscience Information Framework (SciCrunch) and use Research Resource Identifiers (RRID) in publications.
Data sharing via the National Institute of Mental Health Data Archive (NDA) is expected, with semi-annual submission of descriptive/raw data.

Non-Responsive Topics (Disqualifying Factors)

Projects with a central focus on scaling assays or adapting for compound screening.
Strategies directed toward cell therapy or regenerative medicine.
Developing MPS assays exclusively from non-human tissues.
Assays aiming to recapitulate 3-germ-layer gastrula-like structures (e.g., gastruloids).
Assays based on pre-gastrulation human-nonhuman chimeric manipulation, or those potentially involving human contributions to the germline.
Utilization of existing technologies that do not significantly advance the state-of-the-art.

Special Considerations

This R21 grant mechanism supports exploratory/developmental research, encouraging high risk/high reward projects that may lack preliminary data.
Collaboration with experts from diverse fields (e.g., developmental neurobiology, stem cell biology, circuit and systems level neuroscience, materials science, engineering, bioethics) is strongly encouraged.
Mandatory disclosure of federal criminal law violations affecting federal awards is required.

Grant Details