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Grant Analysis

Purpose & Target

Develop novel brain stimulation devices or significantly enhance existing FDA-approved/cleared devices for treating mental health disorders.
Target recipients are research organizations and entities capable of engineering and pre-clinical development.
This is a SECTOR-SPECIFIC grant, focusing on mental health and neurotechnology.
Geographic scope is global, with eligible organizations from the U.S. and non-U.S. (foreign entities) able to apply.
Key filtering criteria include a focus on novel or significantly enhanced neuromodulation hardware/software, exclusion of clinical trials, and requirement for multi-disciplinary teams.
This is a recurring grant opportunity, reissuing PAR-22-038, using the R21 Exploratory/Developmental Research Grant mechanism.

Financial Structure

Max Funding Amount: Total direct costs may not exceed $275,000 for the entire two-year project period.
Annual Funding Limit: No more than $200,000 may be requested in any single year.
Project Period: The total project period may not exceed 2 years.
Eligible Costs: Direct costs for engineering development, hardware/software development, validation, benchtop testing, and necessary animal and limited non-clinical trial human testing. Costs for collecting and submitting Common Data Elements (CDEs) to NIMH Data Archive (NDA) should be included.
Ineligible Costs: Costs associated with clinical trials are not eligible.
Matching Funds: No cost sharing is required for this NOFO.
Financial Reporting: Annual Research Performance Progress Reports (RPPR) and financial statements are required. A final RPPR, invention statement, and expenditure data are required for closeout.

Eligibility Requirements

Organizational Eligibility

Eligible Organization Types:
- Higher Education Institutions (Public/State Controlled, Private)
- Nonprofits (501(c)(3) IRS Status and others)
- For-Profit Organizations (Small Businesses and others)
- Local Governments (State, County, City or Township, Special District)
- Indian/Native American Tribal Governments (Federally Recognized and others)
- Federal Governments (Eligible Agencies, 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).
Required Registrations (prior to application submission):
- System for Award Management (SAM) - active registration required, renew annually.
- NATO Commercial and Government Entity (NCAGE) Code for foreign organizations (in lieu of CAGE code).
- Unique Entity Identifier (UEI) - issued via SAM.gov, must be consistent across all registrations and application.
- eRA Commons - organization must be registered, with at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
- Grants.gov - active SAM registration needed for Grants.gov registration.

Individual/Team Eligibility

Program Director/Principal Investigator (PD/PI): Any individual with skills, knowledge, and resources to carry out proposed research.
Team Composition: Must comprise a multi-disciplinary team of investigators with expertise in fields such as engineering, device development, physical, mathematical, computational sciences, neuroscience, neuropsychiatry, biological sciences, and clinical/regulatory science/affairs.
Industry Partnership: Encouraged (description of contribution and letter of support required if applicable).

Scope Restrictions

Clinical Trials: Not Allowed. Applications proposing clinical trials will not be reviewed.
Incremental Improvements: Incremental changes (e.g., software updates) to existing devices are not within scope.
Low Spatial Resolution Devices: Applications involving devices with low spatial resolution are not responsive.
Non-Specific Models: Models not specific to individual patient anatomy are not responsive.
No Human Application Potential: Devices with no clear potential for human application are not responsive.
Hypothesis-Driven Clinical Studies: Studies of scientific or clinical hypotheses that simply utilize current brain stimulation devices are outside the scope.
Co-enrollment: If human subjects are involved, information on planned or anticipated co-enrollment in other studies must be provided, along with ethical implications, risks, benefits, and mitigating actions.

Application Process

Applications must be submitted electronically through NIH ASSIST, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Applicants must track their application status in eRA Commons.

Submission Deadlines and Dates

Open Date (Earliest Submission Date): January 16, 2025
Application Due Dates (New applications):
- February 16, 2025
- June 16, 2025
- October 16, 2025
- February 16, 2026
- June 16, 2026
- October 16, 2026
- February 16, 2027
- June 16, 2027
- October 16, 2027 (Latest new application deadline)
Application Due Dates (Renewal/Resubmission/Revision):
- March 16, 2025
- July 16, 2025
- November 16, 2025
- March 16, 2026
- July 16, 2026
- November 16, 2026
- March 16, 2027
- July 16, 2027
- November 16, 2027 (Latest overall deadline)
Submission Time: All applications are due by 5:00 PM local time of the applicant organization.
Expiration Date: January 08, 2028 (this is when the NOFO closes for submissions).
Early Submission: Applicants are encouraged to apply early to allow time for corrections.

Required Documentation and Materials

SF424(R&R) forms: Standard cover, project/performance site locations, other project information, senior/key person profile, R&R or Modular Budget, R&R Subaward Budget.
Intellectual Property (IP) Strategy: A required attachment titled 'IP Strategy.pdf'. Must describe IP landscape, constraints, how they'll be addressed, patent filing details, and future IP plans (including multi-PD/PI or multi-institution management).
PHS 398 Cover Page Supplement
PHS 398 Research Plan: Includes the Research Strategy, which must detail:
- How the approach uses multidisciplinary methods.
- How new devices lead to new capabilities.
- Multi-disciplinary team's expertise and experience.
- Contribution of industry collaborators (if applicable).
- Anticipated risks and limitations.
- Co-enrollment information for human subjects.
- Justification for animal/non-clinical human testing and scaling methods for human use.
- Current State-of-the-Art and proof-of-concept tests.
- Relationship with industry/commercial partners (if applicable).
- Regulatory process for new technology (if applicable).
- Translational Plan (regulatory, reimbursement, commercialization, implementation, dissemination).
- Milestones and Timeline (concrete indicators of progress, quantitative metrics).
Letters of Support: Required from any industry partners (if applicable).
Resource Sharing Plan
Data Management and Sharing Plan: Must comply with 2023 NIH Policy. Expected data sharing via the National Institute of Mental Health Data Archive (NDA).
PHS Human Subjects and Clinical Trials Information form: Required if human subjects are involved, including Study Record or Delayed Onset Study record.
PHS Assignment Request Form

Application Assistance

eRA Service Desk: For system questions, errors, warnings, submission issues (online, phone: 301-402-7469 or 866-504-9552).
General Grants Information: For application instructions and processes (email: [email protected], phone: 301-480-7075).
Grants.gov Customer Support: For Grants.gov registration and Workspace (phone: 800-518-4726, email: [email protected]).
Scientific/Research Contact: Dr. Jessica Tilghman (NIMH) for scientific inquiries (email: [email protected], phone: 301-827-0439).
Financial/Grants Management Contact: Rita Sisco (NIMH) for financial questions (email: [email protected], phone: 301-443-2805).
Pre-submission: Strong encouragement to contact Scientific/Research Contacts at NIMH prior to submission.

Evaluation Criteria

Scored Review Criteria These factors directly contribute to the Overall Impact score, and Factors 1 and 2 receive separate scores. - Factor 1: Importance of the Research (Significance and Innovation) - Potential for significant impact on biomedical or biobehavioral research. - Novelty of scientific ideas, model systems, tools, or technologies. - How the proposed new technology or improvements measure against the current state-of-the-art. - Clarity of proof-of-concept tests and alternative strategies if the initial approach fails. - Discussion of how results will inform future tool development (e.g., in other model systems or human brain). - Factor 2: Rigor and Feasibility (Approach) - Use of engineering, physical science, computational, or other multidisciplinary methods to address the biomedical problem. - Description of how integration of existing elements leads to new capabilities if applicable. - Justification for any animal or non-clinical trial human testing as necessary for device development. - Description of how animal methods would scale up for human use. - Robustness of the proposed methods and potential for success. - Factor 3: Expertise and Resources (Investigator(s) and Environment) - Sufficient depth and breadth of the multidisciplinary team's expertise. - Team's experience and technical skills for developing and validating quantitative tools. - Contribution and commitment of industry collaborators (if applicable). Additional Review Criteria (Considered but not scored)

Protections for Human Subjects
Vertebrate Animals
Biohazards
Resubmissions: Evaluation of the full application as presented.
Renewals: Evaluation of progress made in the last funding period.
Revisions: Evaluation of appropriateness of proposed scope expansion.
Authentication of Key Biological and/or Chemical Resources: Evaluation of plans for identifying and ensuring validity of resources.
Budget and Period of Support: Evaluation of justification and reasonableness in relation to proposed research.

Review and Selection Process

Applications undergo scientific peer review by Scientific Review Groups.
Reviewed applications receive a written critique.
Highest scientific and technical merit applications (generally top half) are discussed and assigned an overall impact score.
Funding decisions are based on scientific/technical merit, availability of funds, and relevance to program priorities.

Compliance & Special Requirements

Regulatory Compliance

Adherence to NIH Grants Policy Statement, Federal Regulations (2 CFR Part 200, 42 CFR Part 52), Public Health Service Act (42 USC 241 and 284), and all applicable federal statutes and regulations.
Must follow nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Required to use health IT meeting standards in 45 CFR Part 170, Subpart B if applicable.
Required to use ONC Health IT Certified Program technology for eligible clinicians/hospitals if applicable.
Must describe the regulatory process for new technology.

Data Management and Privacy

Data Management and Sharing Plan required. Data must be shared via the National Institute of Mental Health Data Archive (NDA).
Expected to use NDA's Global Unique Identifier (GUID) and Data Dictionary technology.
Data quality certification required before submission to NDA.
Semi-annual submission of descriptive/raw data (Jan 15, July 15); other data at publication or end of grant.
Plans and procedures modeled after the NIST Cybersecurity Framework required if access to HHS systems/data (including PII/PHI) is involved.

Ethical Standards

Studies involving human subjects must include information on co-enrollment, ethical implications, risks, and benefits.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval required for human subject research.

Intellectual Property (IP)

A dedicated IP strategy attachment is mandatory, addressing the IP landscape, potential constraints, and future filing plans.

Special Considerations

Clinical Trial Not Allowed: This grant strictly prohibits applications involving clinical trials.
R21 Mechanism: Encourages high-risk, proof-of-concept applications that may lack preliminary data, or smaller projects closer to final form.
Focus on Innovation: Novel devices or significant enhancement of existing ones; incremental changes are not supported.
Multi-disciplinary Teams: A crucial requirement for applicants, ensuring diverse expertise.
Translational Pathway: Applicants must describe the potential regulatory, reimbursement, commercialization, implementation, and dissemination pathways for their devices.
Data Sharing: Strict adherence to NIH's Data Management and Sharing Policy, with mandatory sharing via NDA.

Grant Details