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Grant Analysis

Purpose & Target

This grant, PAR-23-157, aims to support exploratory and developmental clinical research focused on understanding the neurobiological mechanisms underlying Substance Use Disorders (SUD). It is primarily for researchers and institutions globally who can conduct high-risk, high-reward studies to advance scientific knowledge in this area. This grant is SECTOR-SPECIFIC, focusing on healthcare research related to substance use. The primary target recipients are research organizations of various types, from higher education institutions to non-profits and for-profit organizations, as well as government entities. The grant uses a phased innovation award mechanism (R61/R33), with an initial exploratory phase followed by a potential expansion phase.

Financial Structure

This grant operates as a Grant, providing money or property to the recipient. There are no cost-sharing requirements, meaning matching funds are not required from the applicant. Budget Allotment:

R61 Planning Phase: The combined budget for direct costs for up to two years cannot exceed $500,000 USD.
R33 Phase: There are no specific budget limits for this phase; however, the requested budget must accurately reflect the project's needs. If your application requests $500,000 USD or more in direct costs in any single year during the R33 phase (excluding consortium F&A), you must contact a Scientific/Research Contact at least 6 weeks before submitting your application.

Eligible and Ineligible Costs:

Pre-award costs are generally allowable as described in the NIH Grants Policy Statement.
No specific list of ineligible costs is provided, but all costs must align with federal regulations and the proposed research scope.

Financial Reporting:

Recipients are required to submit an annual Research Performance Progress Report (RPPR) and other financial statements as specified in the NIH Grants Policy Statement.
A final RPPR, invention statement, and expenditure data are required for award closeout.
For subawards over $25,000 USD, recipients must report to the Federal Subaward Reporting System (FSRS).
Organizations with federal awards totaling over $10,000,000 USD must report on civil, criminal, and administrative proceedings in the System for Award Management (SAM).

Eligibility Requirements

To be eligible for this grant, your organization must fall into one of the following categories:

Higher Education Institutions: Both public/state controlled and private universities and colleges.
Nonprofits: This includes organizations with or without 501(c)(3) IRS status.
For-Profit Organizations: Both 'Small Businesses' and larger 'For-Profit Organizations (Other than Small Businesses)' are eligible.
Local Governments: This covers a wide range including State, County, City/Township, Special District, and Indian/Native American Tribal Governments (both Federally Recognized and Other than Federally Recognized).
Federal Government: Eligible agencies of the Federal Government and U.S. Territory or Possession entities.
Other: This broad category includes 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 Eligibility

Domestic (U.S.) and Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Foreign components of U.S. organizations are also allowed.

Required Registrations All applicant organizations must complete and maintain active registrations with the System for Award Management (SAM), obtain a Unique Entity Identifier (UEI), and register with eRA Commons and Grants.gov. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code instead of a CAGE code for SAM registration. These registrations can take 6 weeks or more, so initiate them early. Principal Investigator (PD/PI) Requirements

Any individual with the necessary skills, knowledge, and resources can serve as a PD/PI. All PD(s)/PI(s) must have an eRA Commons account affiliated with the applicant organization.

Application Limits

Organizations may submit more than one application, provided each is scientifically distinct. Duplicate or highly overlapping applications will not be accepted.

Application Process

Application Submission Process:

Applications must be submitted electronically using the SF424 (R&R) Application Guide.
You can submit through NIH ASSIST, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
It is critical to follow all instructions in the Application Guide and this funding opportunity. Applications that are incomplete, non-compliant, or non-responsive will not be reviewed.

Key Dates:

Latest Application Due Date: March 13, 2026, by 5:00 PM local time of the applicant organization.
Letter of Intent (LOI) Due Date: 30 days prior to the application due date (recommended, but not required or binding).
Expiration Date of NOFO: May 08, 2026.

Required Documentation and Materials:

SF424 (R&R) Forms: Includes Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R Budget, and R&R Subaward Budget.
PHS 398 Research Plan: This is crucial and requires specific structure:
- Specific Aims: Clearly demarcate aims for both the R61 and R33 phases on a single attachment. R61 aims focus on testing the proposed concept; R33 aims outline the plan for expansion if R61 milestones are met.
- Research Strategy: Include separate, labeled sections for R61 and R33 phases. The R61 section should detail critical experiments. The R33 section should describe how the study will develop and expand, providing enough detail for merit evaluation based on anticipated results.
- Milestones (Required): These are essential for R33 transition. They must be included as the last element of the Research Strategy, be well-defined, quantifiable, and scientifically justified. They should not just restate aims, and clinical meaningfulness is encouraged (e.g., effect size, multiple quantitative indicators).
Resource Sharing Plan: Required.
Data Management and Sharing Plan: Required for due dates on or after January 25, 2023.
PHS Human Subjects and Clinical Trials Information: Required if human subjects research or clinical trials are involved.
Appendix: Only limited materials are allowed (e.g., blank questionnaires/surveys). No publications or other non-permitted materials.

Pre-application Requirements:

If requesting $500,000 USD or more in direct costs in any single year of the R33 phase, you must contact a Scientific/Research Contact at least 6 weeks prior to submission.

Timeline and Implementation:

Grant Duration: Maximum 5 years (up to 2 years for R61 phase, up to 3 years for R33 phase).
R61 to R33 Transition: Transition is contingent on successfully meeting R61 milestones and is not guaranteed. A transition package (R61 progress report, R33 research description) must be submitted at least two months before the R61 phase completion. Approximately 50% of R61 grants are expected to transition to R33.
Reporting Obligations: Annual Research Performance Progress Reports (RPPR) and financial statements are required.

Application Assistance:

Contact the eRA Service Desk for system-related issues.
Contact General Grants Information for application instructions.
Contact Grants.gov Customer Support for Grants.gov registration and Workspace issues.
Specific Scientific/Research Contacts and Financial/Grants Management Contacts are provided for inquiries.

Evaluation Criteria

Applications are rigorously evaluated for scientific and technical merit using the following criteria:

Overall Impact: Assesses the likelihood of the project exerting a sustained, powerful influence on the research field, considering all other criteria.
Significance: Examines if the project addresses an important problem or critical barrier in the field. Reviewers consider the rigor of prior research, how scientific knowledge/technical capability/clinical practice will improve, and how successful completion will change concepts, methods, or interventions. For clinical trials, the scientific rationale, necessity, and potential to advance understanding or practice are evaluated.
Investigator(s): Evaluates if the PD(s)/PI(s), collaborators, and other researchers are well-suited, experienced, and have a strong record of accomplishments. For collaborative projects, the complementary expertise and leadership structure are assessed. For clinical trials, expertise in coordination, data management, and statistics, as well as the organizational structure for multi-center trials, are reviewed.
Innovation: Focuses on whether the application challenges current paradigms by utilizing novel theoretical concepts, approaches, methodologies, instrumentation, or interventions. It considers if the innovation is new to the specific field or broadly novel, or if it proposes a refinement or new application of existing elements.
Approach: Assesses the overall strategy, methodology, and analyses for their soundness and appropriateness. Reviewers look for plans to address weaknesses in prior research, ensure robust and unbiased approaches, manage risky aspects (for early-stage projects), and address relevant biological variables (e.g., sex). For human subjects research and clinical trials, plans for protecting human subjects, inclusion/exclusion criteria, study design (justification, power, sample size, population, interventions, ethics, recruitment, randomization, masking, controls), and data management/statistical analysis are thoroughly reviewed.
- Specific to this NOFO: A critical element is how well-defined and quantitative the milestones for the R61 Phase are, and how clearly the R33 Phase will develop and expand upon the R61's completion.
Environment: Determines if the scientific environment (institutional support, equipment, physical resources) contributes to success and if the project benefits from unique features or collaborative arrangements. For clinical trials, the suitability of administrative, data coordinating, enrollment, and laboratory/testing centers, as well as the capability to conduct the trial at proposed sites, are reviewed.

Additional Review Criteria (not separately scored, but considered for overall impact):

Study Timeline: Feasibility of the timeline, incorporation of efficiencies, and discussion of potential challenges and solutions.
Protections for Human Subjects: Justification for involvement, adequacy of protection against risks, potential benefits, importance of knowledge gained, and data/safety monitoring.
Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Evaluation of plans for inclusion (or exclusion) based on scientific justification.
Vertebrate Animals: Assessment of procedures, justifications for use, minimization of discomfort, and euthanasia methods.
Biohazards: Assessment of potential hazards and proposed protections.
Resubmissions: Evaluation of the application, taking into account responses to previous review comments and changes made.
Foreign Organizations: Assesses if the project offers unique opportunities for research advancement using resources or populations not readily available in the U.S.

Compliance & Special Requirements

Regulatory Compliance:

All awards are subject to the Public Health Service Act, Federal Regulations 42 CFR Part 52, 45 CFR Part 75, and 2 CFR Part 200, as well as the NIH Grants Policy Statement.
Recipients must comply with federal civil rights laws prohibiting discrimination based on race, color, national origin, age, sex, and disability. This includes ensuring meaningful access for persons with Limited English Proficiency and effective communication with persons with disabilities.
Compliance with federal conscience laws and associated anti-discrimination laws is required.
Awards are subject to Federal Awardee Performance and Integrity Information System (FAPIIS) requirements for reviewing applicant integrity and performance.

Specific Approvals and Policies:

For human subjects research, Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is mandatory.
Clinical research projects involving investigational therapeutics, vaccines, or medical interventions must comply with Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements.
A Data Management and Sharing Plan is required (effective for applications due on or after January 25, 2023).
ClinicalTrials.gov: If the award involves clinical trials, the 'responsible party' must register and submit results information.
Data and Safety Monitoring Requirements: Oversight and monitoring of human biomedical and behavioral intervention studies are required to ensure participant safety and data integrity.
Biohazards: If applicable, reviewers will assess proposed protections against hazardous materials or procedures.
Select Agent Research: Specific requirements apply for research involving select agents.
Resource Sharing Plans: Reviewers will comment on the reasonableness of plans for sharing resources (e.g., model organisms) or the rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Brief plans are required to identify and ensure the validity of these resources.

Special Considerations:

This NOFO utilizes an R61/R33 Phased Innovation Award, specifically designed for exploratory and developmental clinical research that may involve considerable risk. This unique structure allows for initial exploratory work (R61) with the potential for expansion (R33) if milestones are successfully met.
Preliminary data are not required, but applicants may include them if available to demonstrate study feasibility.
Applicants are strongly encouraged to contact Program Staff to discuss potential research projects prior to applying.
NIDA applicants should review and adhere to the Special Considerations for NIDA Funding Opportunities and Awards.

Grant Details