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Grant Analysis

Purpose & Target

Core objective: To encourage innovative pilot research that informs and supports the delivery of high-quality, continuously improving mental health services.
Explicit identification of target recipient type and size: The grant targets a broad range of organizations including higher education institutions, non-profits, for-profit organizations (small businesses and others), various levels of government, and other specialized entities (e.g., independent school districts, faith-based groups). There are no specific size limitations.
MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': This grant is SECTOR-SPECIFIC.
Geographic scope and any location requirements: Open to entities within the United States, including U.S. Territories, and non-domestic (foreign) organizations. Research can focus on mental health needs globally, including in Low- and Middle-Income Countries (LMICs).
Key filtering criteria for initial grant screening:
Focus on innovative pilot mental health services research.
Projects must not involve clinical trials.
Research should align with Goal 4 of the NIMH Strategic Plan for Research.
Must address mental health services for individuals with, or at risk for, mental illness or autism spectrum disorder.
Grant frequency and program context: This is a recurring funding opportunity with multiple application due dates annually until January 2028, issued by the National Institute of Mental Health (NIMH) under the National Institutes of Health (NIH).

Financial Structure

Funding instrument: Grant (financial assistance).
Maximum direct costs: Limited to $450,000 over the R34 project period.
Annual direct costs limit: No more than $225,000 in direct costs allowed in any one year.
Project period limit: May not exceed three years.
Currency: USD.
Cost sharing: Not required, implying a 100.0% funding rate for eligible costs.
Pre-award costs: Allowable as described in the NIH Grants Policy Statement Section 7.9.1.
Data submission costs: Costs associated with collecting and submitting Common Data Elements (CDEs) and data to the NIMH Data Archive (NDA) should be included in the requested budget.

Eligibility Requirements

Organizational Types

Higher Education Institutions: Public/State Controlled Institutions of Higher Education, Private Institutions of Higher Education
Nonprofits: Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education), Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
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 Governments: Eligible Agencies of the Federal Government, 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 Location

Eligible entities include those based in the U.S. and U.S. Territories.
Non-domestic (non-U.S.) Entities (Foreign Organizations) are also eligible to apply.

Project Type & Scope

Proposed research must not involve clinical trials. The announcement specifically accepts applications that do not propose clinical trials.
Focus on innovative pilot mental health services research, including natural experiments (not clinical trials), survey or mixed methods research, clinical epidemiology, and development/refinement of new research tools, technologies, measures, or methods.
Studies seeking to develop, refine, or evaluate services or system interventions must not employ NIH-defined clinical trial designs (e.g., must not prospectively assign participants to one or more interventions).
Applications whose scope of work primarily involves the provision of direct services (e.g., creating a clinic or center) are not responsive.
Applications that do not include mental health services research or have no clearly articulated relevance to people with or at risk for mental illness or autism spectrum disorder are not responsive.

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 via SAM.gov registration; must be consistent across all registrations and the grant application.
eRA Commons - requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account.
Grants.gov - requires an active SAM registration.
Program Directors/Principal Investigators (PD(s)/PI(s)) must have an eRA Commons account affiliated with the applicant organization.

Application Limitations

Applicant organizations may submit more than one application, provided each application is scientifically distinct.
NIH will not accept duplicate or highly overlapping applications under review at the same time.

Application Process

Application Submission

Application package access: Available through NIH ASSIST system, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Submission method: Applications must be submitted electronically via Grants.gov. Paper applications are not accepted.
Tracking: Applicants must track the status of their application in eRA Commons.
Corrections: Applicants are encouraged to apply early to allow time for corrections to errors found during submission. Errors must be corrected and a changed/corrected application submitted by the due date.

Deadlines

Latest Application Due Date for New applications: 2027-10-16 17:00 (5:00 PM local time of applicant organization).
Latest Application Due Date for Renewal / Resubmission / Revision applications: 2027-11-16 17:00 (5:00 PM local time of applicant organization).
Letter of Intent Due Date: 30 days prior to the application due date (not required, not binding, but encouraged).
Funding Opportunity Expiration Date: 2028-01-08.

Required Documentation / Materials

Applicants must follow instructions in the Research (R) Instructions in the How to Apply - Application Guide and specific instructions in this Notice of Funding Opportunity (NOFO).
Standard Application Forms:
SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile.
R&R or Modular Budget, R&R Subaward Budget.
PHS 398 Cover Page Supplement, PHS 398 Research Plan.
PHS Human Subjects and Clinical Trials Information (if human subjects involved).
PHS Assignment Request Form.
Research Strategy section must include detailed information on:
Significance (Importance of the Research).
Innovation (Importance of the Research).
Approach (Rigor and Feasibility).
Environment (Expertise and Resources).
Resource Sharing Plan: Required.
Data Management and Sharing Plan: Required for all research generating scientific data.
Appendix: Only limited materials are allowed, specifically blank questionnaires or blank surveys. No publications or other material.
Human Subjects Study Record: Required if human subjects are involved.
Recruitment and Retention Plan: Must provide clear descriptions of recruitment/referral sources, monitoring procedures, strategies for a robust sample, potential challenges and mitigation, and evidence of enrollment feasibility.
Study Timeline: Must provide objective, quantifiable, and justifiable benchmarks for project milestones.

Post-Award Requirements

Annual Research Performance Progress Report (RPPR).
Financial statements as required by the NIH Grants Policy Statement.
Final RPPR, invention statement, and expenditure data are required for closeout.
Adherence to the 2023 NIH Policy for Data Management and Sharing.
Recipients must implement their approved Data Management and Sharing Plan.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for protocols involving human subjects.

Application Assistance

eRA Service Desk: For system questions (ASSIST, eRA Commons, errors, submission issues).
General Grants Information: For application instructions and NIH grant resources.
Grants.gov Customer Support: For Grants.gov registration and Workspace issues.
Specific contacts available for Scientific/Research inquiries (general and LMICs research), Peer Review, and Financial/Grants Management.

Evaluation Criteria

Overall Impact

Reviewers provide an overall impact score reflecting the likelihood of the project to exert a sustained, powerful influence on the research field.

Scored Review Criteria

Factor 1. Importance of the Research (Significance and Innovation)
Significance: How the research will generate data for future full research projects (e.g., an R01 application).
Potential for broad use of results (especially for methods development).
Quality of collaborations and input from community partners, policymakers, and health leaders.
Degree to which research is deployment-focused and ensures utility to community practice/stakeholders.
Potential public health impact (reach, effect on target populations, meaningfulness of anticipated outcomes).
Scalability of proposed services intervention (if applicable), considering typically available resources and financing mechanisms.
Innovation: Presence and description of innovative research strategies, design, or analytic elements.
Contribution of information technology to new knowledge, research efficiency, or improved outcomes.
Factor 2. Rigor and Feasibility (Approach)
Description of mutable factors impacting mental health services (access, continuity, utilization, quality, value, financing, effectiveness, outcomes, scalability) as targets for future intervention development.
For tool/method development: Likelihood of leading to validated and deployable products, services, or methodologies broadly usable in community practice settings.
For data integration/analysis: How results will enhance understanding of factors affecting access, continuity, quality, delivery, efficiency, financing, value, effectiveness, or outcomes of care.
Quality of planned collaboration and stakeholder input, and their contribution to study utility (e.g., advisory board with decision makers).
Evidence of valid and reliable outcome measures that are meaningful to stakeholders.
Plans for detection and clinical management of suicidal behavior/ideation and non-suicidal self-harm for patient-level outcomes.
Factor 3. Expertise and Resources (Investigator(s) and Environment)
How the study leverages resources and expertise from existing infrastructure (e.g., CTSAs, practice-based research networks, NIMH investments, electronic medical records, administrative databases, patient registries).
Justification provided if such efficiencies cannot be incorporated.

Additional Review Criteria (Not Scored, but Impact Overall Score)

Protections for Human Subjects: Justification for involvement, adequacy of protection, potential benefits, importance of knowledge gained, data and safety monitoring (for clinical trials, if applicable).
Vertebrate Animals: Justification for use, appropriateness of species, interventions to minimize discomfort, justification for euthanasia method (if applicable).
Biohazards: Evaluation of specific materials/procedures and proposed protection.
Resubmissions/Renewals/Revisions: Evaluation of the updated application, progress, or scope expansion, respectively.

Additional Review Considerations (Not Scored, No Impact on 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 and project duration.

Compliance & Special Requirements

Regulatory Compliance

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 mandatory.
Recipients must follow all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
All federal statutes and regulations relevant to federal financial assistance apply.
Mandatory disclosure: Recipients must submit information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award.

Data Management and Sharing

A Data Management and Sharing Plan is required for all applications generating scientific data.
Data sharing is expected via the National Institute of Mental Health Data Archive (NDA), utilizing Global Unique Identifier (GUID) and Data Dictionary technology.
Submission of descriptive/raw data is expected semi-annually (January 15 and July 15).
Submission of all other data is expected at the time of publication or prior to the end of the grant, whichever occurs first.
Investigators must certify the quality and accuracy of submitted data.
NIMH expects the collection of Common Data Elements (CDEs) for mental health human subjects research, with associated costs included in the budget.

Research-Specific Requirements

Clinical Trial Not Allowed: This funding opportunity strictly prohibits proposals for NIH-defined clinical trials. Research must not involve prospectively assigning participants to interventions to evaluate their effects.
Human Subjects Research: If involving human subjects, comprehensive protection plans and compliance with ethical standards are required.
Vertebrate Animals Research: If involving vertebrate animals, justification for their use, appropriateness, and measures to minimize discomfort/pain must be detailed.
Biohazards: If hazardous materials or procedures are used, adequate protection measures must be proposed.
Health Information Technology (Health IT): If funding involves implementing, acquiring, or upgrading health IT, it must meet standards in 45 CFR part 170, Subpart B, and potentially be certified under the ONC Health IT Certification Program.
Cybersecurity: Recipients with ongoing access to HHS information/operational technology systems or handling Personal Identifiable Information (PII)/Personal Health Information (PHI) must develop plans modeled after the NIST Cybersecurity framework.

Special Considerations

The grant supports exploratory/developmental research; extensive background material or preliminary data, typical for R01 applications, are not required but can be included if available.
Strong encouragement for developing and leveraging research-practice partnerships with public and private stakeholders to ensure deployment-focused models and practical utility of findings.
Emphasis on capitalizing on existing infrastructure (e.g., practice-based research networks, electronic medical records, administrative databases) to increase efficiency.
High priority is given to pilot research on innovative service delivery models that seek to reduce disparities in service access, quality, and outcomes for underserved groups (e.g., racial/ethnic minorities, individuals with language/cultural barriers, rural communities).
Proposed projects must have clear relevance to people with or at risk for mental illness or autism spectrum disorder.
Studies focusing on stigma or health literacy are not responsive if they do not also examine mental health policy, actual service access, engagement, quality, or outcomes of care.

Grant Details