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Grant Analysis

Purpose & Target

Grant Purpose and Target This grant, PAR-25-353, aims to accelerate innovative drug and device discovery and development for mental disorders. Its core objective is to advance preclinical development, early-stage human studies, and proof-of-concept (PoC) testing of new, rationally-based candidate agents or devices to treat mental illnesses. The grant explicitly targets academic institutions, the biotechnology industry, the biomedical device industry, and the pharmaceutical industry. It encourages the formation of multidisciplinary teams and public-private partnerships. There are no specific organizational size limits mentioned, but the nature of the research suggests medium to large research-capable entities. It is a SECTOR-SPECIFIC grant, focusing primarily on healthcare, pharmaceuticals, and biotechnology related to mental health. The geographic scope is strictly limited to organizations based in the United States. Foreign organizations are not eligible to apply, though foreign components within U.S. applications are allowed. Key filtering criteria for initial screening include being a U.S.-based entity involved in drug or device discovery/development for mental disorders, with an emphasis on novel interventions (not just analogs of existing treatments) and a willingness to engage in multidisciplinary collaborative research up to early human clinical trial phases. This grant is a recurring opportunity, a reissue of a previous program (PAR-22-144), with multiple application due dates occurring annually until October 2027, indicating an ongoing program context.

Financial Structure

Budget Range and Limitations: The grant states that application budgets are not limited, but they must reflect the actual needs of the proposed project. This means there is no pre-set maximum or minimum award amount.
Cost Sharing/Matching Funds: This funding opportunity does not require cost sharing or matching funds.
Eligible and Ineligible Costs: While not extensively itemized, the grant implies coverage for typical research and development expenses, including personnel (for temporarily hired staff), consultant costs, equipment, supplies, and travel. However, for NIH intramural scientists involved as collaborators, their salary and related fringe benefits (for permanent Federal employees) and costs related to administrative or facilities support (F&A costs) are ineligible to be requested in the grant application; these are covered by the NIH Intramural Program.
Co-financing: While not required financially, the program strongly encourages in-kind resource contributions from partners, such as biotechnology, pharmaceutical companies, or disease foundations, as part of the collaborative NCDDG model.
Payment Schedule and Mechanisms: Awards are provided through a Cooperative Agreement, which signifies substantial Federal scientific or programmatic involvement post-award. The specific payment schedule is not detailed but implies ongoing support as the project progresses.
Financial Reporting: Recipients are required to submit annual financial statements (specifically, the Federal Financial Report) and a final financial report for closeout.
Audit Requirements: While not explicitly detailed, adherence to 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards is required, which typically includes audit provisions for federal awards.

Eligibility Requirements

Eligibility Requirements To be eligible for this grant, applicants must meet the following non-negotiable criteria:

Organization Type: A wide range of U.S.-based organizations are eligible, including:
- Higher Education Institutions: Both public/state-controlled and private universities.
- Nonprofits: With or without 501(c)(3) IRS status.
- For-Profit Organizations: This includes both 'Small Businesses' and 'For-Profit Organizations (Other than Small Businesses)'.
- Government Entities: Local (State, County, City or Township, Special District, Indian/Native American Tribal – Federally Recognized and Other) and Federal (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, and Regional Organizations.
Geographic Location: Only U.S.-based entities are eligible to apply. Foreign organizations and non-domestic components of U.S. organizations are explicitly not eligible to be the applying entity, although foreign components are allowed within a U.S. organization's application.
Required Registrations: All applicant organizations must complete and maintain active registrations prior to submission. This process can take 6 weeks or more, so early registration is crucial. Required registrations include:
- System for Award Management (SAM), which requires annual renewal.
- A Unique Entity Identifier (UEI), issued as part of the SAM.gov registration.
- eRA Commons: Organizations must register and identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI).
- Grants.gov: Requires an active SAM registration to complete.
Investigator Eligibility: Any individual with the necessary skills and resources can serve as a Program Director(s)/Principal Investigator(s) (PD/PI). However, NIH intramural scientists cannot serve as PD/PIs but may participate as research collaborators or consultants.
Partnership/Consortium Requirements: This grant strongly encourages and envisions a multi-institutional, group approach. Successful applications are expected to feature multidisciplinary teams of scientists. While not a strict requirement for all applications, the program is designed for Cooperative Drug/Device Discovery/Development Groups (NCDDGs).
Exclusion Criteria: Applications proposing the development of analogs of established or well-studied agents for mental disorders are generally not appropriate for this NOFO. Additionally, applications will be considered non-responsive and will not be reviewed if they propose clinical trials that lack a 'Clinical and Data Monitoring Plan', a 'Milestone Plan', or the 'Common Data Elements Applicability' attachment.

Application Process

Application Practical Information

Application Deadlines: This grant has multiple application due dates. The latest general submission deadline for new, renewal, resubmission, and revision applications is October 25, 2027, by 5:00 PM local time of the applicant organization. Other earlier deadlines also exist in 2025, 2026, and earlier in 2027. The funding opportunity officially expires on October 26, 2027.
Letter of Intent (LOI): While not required or binding, submitting a Letter of Intent is strongly encouraged 30 days before the application due date. It should include the descriptive title, PD/PI information, key personnel, participating institutions, and the funding opportunity number/title. LOIs should be sent via email to [email protected].
Submission Format and Platform: Applications must be submitted electronically using either the NIH ASSIST system or an institutional system-to-system (S2S) solution. Submissions route through Grants.gov to NIH's eRA Commons.
Required Documentation and Materials: Applicants must follow the Multi-Project (M) Instructions from the 'How to Apply - Application Guide'. Key components include:
- Overall Component: SF424(R&R) Cover, PHS 398 Cover Page Supplement, Research & Related Other Project Information (primary site only), Research and Related Senior/Key Person Profile (PD/PI only), Budget (estimated funding only), PHS 398 Research Plan (including an Introduction, Specific Aims, detailed Research Strategy, Measurable Milestones and Timeline, Letters of Support, Resource Sharing Plan, and a mandatory Data Management and Sharing (DMS) Plan), and the PHS Human Subjects and Clinical Trials Information form (if applicable).
- Specific Components: Applications are multi-component and will likely include 'Administrative Core', 'Scientific Core', and 'Research Project' components, each with their own specific forms and content requirements.
- Clinical Trial Specific Attachments (MANDATORY if proposing Clinical Trials):
  - 'Clinical and Data Monitoring Plan.pdf'
  - 'Milestone Plan.pdf'
  - 'Common Data Elements Applicability.pdf'
- Optional Clinical Trial Attachments: 'Clinical Protocol Schedule of Events.pdf', 'Investigator Brochure or Package Insert.pdf' (for drug/biologic), and 'Material safety data sheet (MSDS).pdf' (for investigational device).
Page Limitations: Specific page limits apply to different sections, such as 12 pages for the Overall Research Plan and 6 pages for Administrative Core and Scientific Core Research Plans. These limits must be strictly followed.
Pre-application Requirements: For applications requesting $500,000 or more in direct costs in any single year, applicants must contact a Scientific/Research Contact at least 6 weeks before submitting the application.
Review Process and Timeline: Applications are first evaluated by a Scientific Review Group (peer review), which may include a selection process where only the highest scientific and technical merit applications are discussed. Recommended applications then undergo a second level of review by an appropriate national Advisory Council or Board. Earliest start dates for awards range from December 2025 to October 2028, depending on the application's submission date and review cycle.
Reporting Obligations: Successful recipients are required to submit an annual Research Performance Progress Report (RPPR) and annual financial statements. A final RPPR, invention statement, and expenditure data are required for award closeout.

Evaluation Criteria

Evaluation Criteria Applications will be reviewed based on their scientific and technical merit, ultimately contributing to an 'Overall Impact' score that reflects the project's potential to significantly influence the research field. Key scoring factors include:

Significance: How well the project addresses an important problem or critical barrier in mental health research, its rigor based on prior research, and how it will improve scientific knowledge, technical capability, or clinical practice. Specifically, reviewers will assess the extent to which the proposed discovery and testing advances a new therapeutic candidate for development and the necessity of any proposed clinical trials.
Investigator(s): The qualifications, experience, and training of the PD/PI(s), collaborators, and other researchers. For multi-PD/PI or collaborative projects, the complementary nature of expertise, leadership approach, governance, and organizational structure are evaluated. Emphasis is placed on the extent to which collaborations (especially with the private sector) contribute essential expertise, ensure effective communication, and demonstrate a willingness to share information fully.
Innovation: The degree to which the application challenges existing paradigms or proposes novel theoretical concepts, approaches, methodologies, instrumentation, or interventions. This includes refining, improving, or applying existing concepts in new ways, especially for clinical trial design.
Approach: The soundness of the overall strategy, methodology, and analyses in achieving specific aims. This includes plans to address weaknesses in prior research, ensure unbiased approaches, manage risks, and incorporate relevant biological variables (e.g., sex). For clinical trials, the study design's justification, statistical powering, efficiency, and appropriateness of study populations and interventions are key. Reviewers also assess the scientific rationale for molecular/clinical targets, the relevance of preclinical models, and the design of Phase 1/1b/IIa studies for evaluating target engagement, dosing, safety, and tolerability.
Environment: The scientific environment's contribution to success, including institutional support, available equipment, and physical resources. Unique features, subject populations, or collaborative arrangements (e.g., administrative, data coordinating, enrollment centers) are also considered, especially for multi-site or international trials.

Additional Review Criteria (Not Separately Scored) Reviewers also assess specific aspects without assigning separate scores, which include:

Administrative Core: Evidence of the applying institution's competence and support in serving as the administrative core.
Scientific Cores: How well cores provide essential facilities/services to research projects, the quality of these services, and the qualifications of core personnel.
Research Projects: Justification of clinical trials (citing relevant prior research), the clinical research team's track record in recruitment and study completion, appropriateness and measurability of milestones (including go/no-go decision points), discussion of challenges and solutions, novelty of biological targets, and the appropriate powering of go/no-go studies.
Clinical Data Monitoring Plan: Adequacy of procedures for clinical data monitoring and quality control.
Study Timeline: Detailed, feasible, and justified timeline, including start-up, enrollment, and follow-up, and integration of efficiencies like existing resources.
Protections for Human Subjects: Justification for human subject involvement, adequacy of protection against risks, potential benefits, importance of knowledge gained, and data/safety monitoring plans.
Inclusion of Women, Minorities, and Individuals Across the Lifespan: Plans for inclusion/exclusion based on scientific goals.
Vertebrate Animals: Detailed description of animal procedures, justification for species choice and alternatives, and plans for humane treatment.
Biohazards: Assessment of potential hazards and proposed protections.

Compliance & Special Requirements

Compliance and Special Requirements

Regulatory Compliance: All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement and the U.S. Office of Management and Budget (OMB) administrative guidelines at 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards). Recipients must comply with all applicable nondiscrimination laws.
Human Subjects Protections: For research involving human subjects, compliance with 45 CFR Part 46 regulations is mandatory. This includes strict requirements for data and safety monitoring plans (DSMP). All NIH-defined clinical trials must be registered and results submitted to ClinicalTrials.gov. Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for all protocols. Clinical research involving investigational products or devices (even licensed ones used for new purposes) must comply with FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements.
Data Protection and Sharing: A Data Management and Sharing Plan (DMS Plan) is mandatory for all applications generating scientific data. This plan must detail how protocols and data will be shared, including a schedule/timeline (at a minimum, annual submission of raw and summary data). Data from the NCDDG program must be made available to the research community through publications or public websites. Specifically, data from NIH-supported clinical trials must be submitted to the National Institute of Mental Health Data Archive (NDA), with expectations for semi-annual submission of descriptive/raw data and submission of all other data by publication or grant end. Applicants are expected to certify data quality before submission and use specific tools (e.g., NDA Data Submission Cost Model) for budgeting data sharing activities.
Intellectual Property (IP) Policies: Recipients will retain custody and primary rights to data and software developed under these awards, subject to Government rights of access. However, for collaboration involving NIH intramural scientists, inventions developed in NIH facilities are NIH property unless NIH waives its rights.
Ethical Standards: Applicants must adequately address all ethical issues related to their proposed research.
Cybersecurity: If the project involves consistent access to HHS systems or handling of Personal Identifiable Information (PII) or Personal Health Information (PHI) from the awarding agency, recipients must develop cybersecurity plans and procedures modeled after the NIST Cybersecurity Framework.
Mandatory Disclosure: Recipients must disclose any information related to violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award.
Cooperative Agreement Specifics: This award is a Cooperative Agreement, meaning there will be substantial Federal scientific or programmatic involvement from NIH staff. While the recipient retains prime responsibility, the NIMH Project Scientist will provide guidance, support, and advise on design, management, and resource selection, and will participate (with one vote) in the Steering Committee. The Steering Committee, composed of PD/PI(s), key scientists, collaborators, and NIH staff, oversees the scientific content and direction of the program, facilitates collaboration, and organizes meetings. A Dispute Resolution procedure is in place for scientific or programmatic disagreements.
Prior Approval: Recipient-selected projects involving clinical trials or studies with greater than minimal risk to human subjects require prior approval from NIH before initiation.
Cross-Cutting Considerations: The grant emphasizes the importance of addressing relevant biological variables (e.g., sex) in studies and including women, minorities, and individuals across the lifespan in human subject research, justifying any exclusions scientifically. It also requires assessment of biohazards and adequate protection measures.
Innovation Requirements: The grant encourages innovative, high-impact research focusing on novel molecular targets or neural circuit/oscillatory targets. It explicitly supports novel interventions and discourages the development of analogs of established agents.

Grant Details