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Grant Analysis

Purpose & Target

• Core objective: This grant aims to support pilot and preliminary research studies that test approaches to improve access, quality, effectiveness, affordability, and use of treatments for tobacco, alcohol, and substance use disorders, including related mental and medical conditions. The goal is to prepare for larger-scale effectiveness trials. • Target recipients: Primarily research institutions, non-profits, for-profit organizations, and government entities engaged in health services research. • MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': This grant is SECTOR-SPECIFIC as it focuses exclusively on health services and economic research related to substance use disorders. • Geographic scope: Open to organizations globally, with a strong focus on advancing health outcomes in the US. • Key filtering criteria: Focus on pilot research for SUD treatment services; must not be solely focused on alcohol; interest in implementation science and stakeholder engagement. • Grant frequency: This is a recurring grant opportunity, reissued from a previous announcement (PA-21-180), with multiple application cycles through 2027.

Financial Structure

Max direct costs: $450,000 over the 3-year project period.
Max direct costs per single year: No more than $225,000.
Project period limit: Cannot exceed 3 years.
Currency: USD.
Cost sharing/matching funds: Not required.
Eligible costs: Pre-award costs are allowable as described in NIH Grants Policy Statement Section 7.9.1.
Financial reporting: Annual financial statements and a final Federal Financial Report (FFR) for closeout.
Audit requirements: Subject to rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.

Eligibility Requirements

Eligible Organization Types

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
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)
Small Businesses
For-Profit Organizations (Other than Small Businesses)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal - Federally Recognized & Other)
Federal Government (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

System for Award Management (SAM) - must be active and renewed annually.
NATO Commercial and Government Entity (NCAGE) Code - required for foreign organizations (in lieu of CAGE code for SAM).
Unique Entity Identifier (UEI) - issued via SAM.gov registration.
eRA Commons - organization must register and identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov - must have active SAM registration.

Principal Investigator (PD/PI) Requirements

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research.
Must have an eRA Commons account, affiliated with the applicant organization.

Application Restrictions

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
No duplicate or highly overlapping applications under review at the same time.

Exclusion Criteria

Applications that involve alcohol alone as a substance of use are not responsive and will not be reviewed.
Studies not considered pilot or preliminary research for larger-scale effectiveness trials.

Application Process

Application Submission Process

Submission Methods:
- NIH ASSIST system (online preparation, submission, tracking).
- Institutional system-to-system (S2S) solution.
- Grants.gov Workspace (preparation and submission).
Application Due Dates: Multiple deadlines (latest is February 16, 2027, by 5:00 PM local time of applicant organization).
Early Submission Encouraged: Applicants should apply early to allow time for corrections.
Late Applications: No late applications will be accepted. If a changed/corrected application is submitted after the deadline, it will be considered late.
Tracking: Applicants must track application status in eRA Commons.

Required Documentation and Materials

SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile).
R&R or Modular Budget forms.
R&R Subaward Budget forms (if applicable).
PHS 398 forms (Cover Page Supplement, Research Plan).
Resource Sharing Plan.
Data Management and Sharing Plan (required for all research generating scientific data).
Appendix (limited materials allowed: blank questionnaires or blank surveys only, no publications or other material).
PHS Human Subjects and Clinical Trials Information form (if human subjects involved).

Pre-Application Requirements

Registrations: Applicant organizations must complete and maintain active registrations with:
- System for Award Management (SAM)
- Unique Entity Identifier (UEI)
- eRA Commons (organization and PD/PI accounts)
- Grants.gov
Foreign Organizations: Must obtain a NATO Commercial and Government Entity (NCAGE) Code for SAM registration.
Registration Timeline: Can take 6 weeks or more; start process as soon as possible. Failure to register is not a valid reason for late submission.

Post-Award Requirements & Reporting

Annual Reporting: Research Performance Progress Report (RPPR) and financial statements annually.
Closeout Reporting: Final RPPR, invention statement, and expenditure data (Federal Financial Report portion).
ClinicalTrials.gov: If clinical trials are involved, registration and results reporting are expected.
IRB/IEC Approval: Recipient institutions must ensure all protocols are reviewed by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Data and Safety Monitoring: Required for NIH-supported human biomedical and behavioral intervention studies.
IND/IDE Requirements: For clinical research involving investigational medical interventions.

Evaluation Criteria

Overall Impact

Reviewers will provide an overall impact score reflecting the likelihood of the project to have a sustained, powerful influence on the research field(s).

Factor 1: Importance of the Research

Significance:
- Addresses an important gap in knowledge.
- Solves a critical problem.
- Creates a valuable conceptual or technical advance.
- Strong rationale and rigorous scientific background (e.g., prior literature, preliminary data).
Innovation:
- Applies novel concepts, methods, or technologies.
- Uses existing concepts, methods, or technologies in novel ways to enhance overall impact.
- Note: Projects not applying novel concepts can still be critically important.

Factor 2: Rigor and Feasibility

Rigor:
- Potential to produce unbiased, reproducible, robust data.
- Rigor of experimental design and appropriate controls.
- Sufficient and well-justified sample size.
- Quality of plans for analysis, interpretation, and reporting results.
- Adequate plans to address relevant biological variables (sex, age) in design, analysis, and reporting.
- For human subjects/vertebrate animals: rigor of intervention, justified outcome variables, generalizability/relevance to subgroup, appropriate and diverse sample.
- For human subjects/clinical trials: adequacy of inclusion plans.
Feasibility:
- Proposed approach is sound and achievable.
- Plans to address problems or new challenges.
- If less certain, uncertainty balanced by potential for major advances.
- For human subjects/clinical trials: adequacy and feasibility of recruiting/retaining diverse population; likelihood of achieving enrollment based on age, race, ethnicity, sex; feasible study timeline and milestones.

Factor 3: Expertise and Resources

Investigator(s):
- Demonstrated background, training, and expertise appropriate for career stage.
- For Multiple PI applications, quality of leadership plan for coordination and collaboration.
Environment:
- Institutional resources are appropriate to ensure successful execution of the proposed work.

Additional Review Criteria (No separate scores)

Protections for Human Subjects: Justification for involvement, protection against risks, potential benefits, importance of knowledge gained, data and safety monitoring for clinical trials.
Vertebrate Animals: Description of procedures, justifications for use, interventions to minimize discomfort, justification for euthanasia methods.
Biohazards: Evaluation of hazards and proposed protections for personnel/environment.
Resubmissions/Revisions: Evaluation of the revised application or appropriateness of scope expansion.

Additional Review Considerations (No scores, not for overall impact)

Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity.
Budget and Period of Support: Review of the appropriateness of the budget and requested period of support.

Compliance & Special Requirements

Regulatory Compliance

Federal Regulations: Adherence to 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
NIH Grants Policy Statement: All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement.
Nondiscrimination Laws: Recipients must comply with applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690) upon registering in SAM.gov.
Federal Statutes: Compliance with all federal statutes and regulations relevant to federal financial assistance, including those in NIH Grants Policy Statement Section 4 Public Policy Requirements.
Termination: NIH may terminate awards under certain circumstances (2 CFR Part 200.340 and NIH Grants Policy Statement Section 8.5.2).

Data Protection and Sharing

Data Management and Sharing Plan: Required for all research generating scientific data, consistent with the 2023 NIH Policy. Plan must be implemented upon approval.

Ethical Standards and Oversight

Human Subjects Protections: Compliance with 45 CFR Part 46 for research involving human subjects.
Vertebrate Animals: Compliance with guidelines for the involvement of live vertebrate animals.
Biohazards: Adequate protection must be proposed if hazardous materials or procedures are used.
Mandatory Disclosure: Recipients must disclose information related to violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award.

Intellectual Property Policies

Invention Statement: Required for closeout of an award, implying intellectual property reporting.

Special Considerations

Clinical Trial Optional: Applications can propose or not propose clinical trials.
Focus on Translation: Strong encouragement to use methods like implementation science, hybrid implementation/effectiveness trials, and dissemination research to accelerate translation of insights into practice.
Stakeholder Engagement: Meaningful engagement of practitioners and community stakeholders in study design and execution is encouraged.
Scalability and Sustainability: Proposed interventions should consider potential scalability and sustainability, including payment and funding models.
Health Disparities: Relevance to health disparities and underserved populations is a key consideration.
Patient/Recipient Perspectives: Incorporating input from patients or service recipients is encouraged.
Technology Use: Interest in using technology to efficiently deliver, target, and personalize interventions across all research areas.
Geographic Scope for Services: Studies may take place in diverse settings, including traditional healthcare, criminal legal settings, social services, and other community settings, with encouragement for non-traditional settings to reach underserved populations.

Grant Details