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Grant Analysis

Purpose & Target

This grant, PA-25-163, from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the NIH, aims to advance research specifically focused on Alcohol Use Disorder (AUD) treatment, pharmacotherapy, and recovery. It is exclusively for projects that involve clinical trials in humans. It is a SECTOR-SPECIFIC grant, targeting the healthcare and research sectors, with a primary focus on individuals affected by AUD. The grant broadly encourages studies on medications, behavioral therapies, recovery processes, translational research, and innovative technologies for AUD treatment. The geographic scope is global, as non-U.S. entities are eligible to apply. Key filtering criteria include the mandatory clinical trial component, the strict focus on AUD (excluding other substance use disorders or HIV-AIDS related studies), and the requirement for human-only studies (no preclinical animal studies). This is a recurring grant opportunity with multiple application deadlines until its expiration in September 2026, reissuing a previous program.

Financial Structure

Funding Amounts:

Maximum Direct Costs: Up to $500,000 per year without prior approval from the Scientific/Research Contact.
Requests for $500,000 or more in direct costs in any single year (excluding consortium F&A) require applicants to contact a Scientific/Research Contact at least 6 weeks before submitting the application.
The total number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Co-financing / Matching Fund Obligations:

No cost sharing is required for this funding opportunity, as defined by the NIH Grants Policy Statement.

Eligible vs. Ineligible Cost Categories:

Specific eligible and ineligible cost categories are not detailed within this NOFO, but all NIH awards are subject to the terms and conditions and cost principles described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 (Selected Items of Cost).
Budget proposals must be fully justified and reasonable in relation to the proposed research.

Payment Schedules and Disbursement Mechanisms:

Payments are typically handled through the designated HHS payment system or office, as authorized by the Notice of Award (NoA).
NIH uses a 'Just-in-Time' process, where specific information (e.g., updated other support, human subjects documentation) is requested only if an application is under consideration for funding.

Financial Guarantees and Security Requirements:

No explicit financial guarantees are mentioned beyond the general requirement for sound business practices and integrity, which NIH assesses by reviewing an applicant’s federal award history in SAM.gov.

Tax Implications and Financial Reporting Requirements:

Tax implications are not detailed in the NOFO, but as a federal award, applicants should consult relevant tax regulations.
Financial reporting: Recipients are required to submit annual Research Performance Progress Reports (RPPR) and financial statements as outlined in the NIH Grants Policy Statement Section 8.4.1. A final RPPR and the expenditure data portion of the Federal Financial Report are required for award closeout.

Eligibility Requirements

To be eligible for this grant, your organization must meet specific criteria and complete required registrations. This grant funds human clinical trials only. Eligible Organization Types:

Higher Education Institutions: Public/State Controlled, Private.
Nonprofits: With 501(c)(3) IRS Status or Without 501(c)(3) IRS Status (other than institutions of higher education).
For-Profit Organizations: Small Businesses, or other For-Profit Organizations (other than Small Businesses).
Local Governments: State, County, City or Township, Special District, Indian/Native American Tribal Governments (Federally Recognized or Other).
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 Eligibility:

Applicants from the U.S. and Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply. Non-domestic components of U.S. Organizations and Foreign components (as defined by NIH Grants Policy Statement) are also allowed.

Required Registrations: All applicant organizations must complete and maintain active registrations prior to application submission. This process can take 6 weeks or more, so start early. * System for Award Management (SAM): Requires annual renewal. Includes assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations. * NATO Commercial and Government Entity (NCAGE) Code: Required for foreign organizations (in lieu of CAGE code) to register in SAM. * Unique Entity Identifier (UEI): Issued as part of the SAM.gov registration process. Must be consistent across all registrations and on the grant application. * eRA Commons: Once UEI is established, organizations can register with eRA Commons. Requires identifying at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account. * Grants.gov: Requires active SAM registration. Eligible Individuals (Program Director/Principal Investigator):

Any individual with the necessary skills, knowledge, and resources to carry out the proposed research is invited to apply. For multiple PDs/PIs, follow NIH's specific policy.
All PD(s)/PI(s) must have an eRA Commons account, affiliated with the applicant organization. This can take up to 2 weeks.

Cost Sharing:

Not required. This NOFO (Notice of Funding Opportunity) does not require cost sharing as defined by the NIH Grants Policy Statement.

Exclusion Criteria / Disqualifying Factors: Applications will not be considered responsive and will not be reviewed if they focus on: * Efficacy and dissemination studies of brief interventions for high-risk and understudied populations (unless specifically tailored and responsive to other call areas). * Approaches that focus on enhancing positive health or other behaviors that might have indirect positive effects on drinking, sleep improvement, or fitness. * The role of life events and social factors as contributors to changes in drinking patterns. * Linking changes in environmental factors (e.g., alcohol availability, price) to changes in drinking. * Preclinical animal studies (only human studies are allowed). * HIV-AIDS related studies. * Studies that include substances other than alcohol or focus on poly-substance use disorders. * Clinical trials on prevention. * Clinical trials in community settings (e.g., community centers, college campuses). * Clinical trials that include organ-associated diseases. * Basic experimental studies involving humans (BESH).

Application Process

Application Process Timeline and Deadlines: This funding opportunity has multiple application due dates until its expiration. All applications are due by 5:00 PM local time of the applicant organization. Application Due Dates for New Applications (latest dates provided in the document): * October 05, 2025 * February 05, 2026 * June 05, 2026 Note: If a submission date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day. Expiration Date: September 08, 2026. Open Date (Earliest Submission Date): January 05, 2025. Letter of Intent Due Date(s): 30 days before the application due date (though not required or binding). Required Documentation and Submission Materials: Applicants must follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide and any program-specific instructions in this NOFO. Key forms and sections include: * SF424(R&R) Cover * SF424(R&R) Project/Performance Site Locations * SF424(R&R) Other Project Information * SF424(R&R) Senior/Key Person Profile * R&R or Modular Budget * R&R Subaward Budget * PHS 398 Cover Page Supplement * PHS 398 Research Plan: This is a critical section. Includes: * Resource Sharing Plan * Data Management and Sharing Plan: Required for all applications, regardless of direct costs, if research generates scientific data. * Appendix: Only limited materials are allowed; specifically, only blank questionnaires or blank surveys. * PHS Human Subjects and Clinical Trials Information: Mandatory if human subjects are involved, including at least one study record (Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record). * PHS Assignment Request Form Submission Format and Platform:

Applications must be submitted electronically.
Options for submission:
- NIH ASSIST system (online preparation, submission, tracking)
- Institutional system-to-system (S2S) solution (for institutions with this capability)
- Grants.gov Workspace (for preparation and submission)
Applicants must track their application status in eRA Commons.
Errors found during submission must be corrected, and a changed/corrected application submitted by the due date.

Pre-Application Requirements:

Letter of Intent: Encouraged, but not required or binding. Should include title, PD(s)/PI(s) info, key personnel, institution(s), and funding opportunity number/title. Email to Philippe Marmillot, Ph.D. at NIAAA.
Registration: Organizations and PD(s)/PI(s) must complete all required registrations (SAM, UEI, eRA Commons, Grants.gov) well in advance of the due date.
Contact for Large Budgets: If requesting $500,000 or more in direct costs in any year, you must contact a Scientific/Research Contact at least 6 weeks before submitting your application.

Types of Support Offered:

This is a Grant mechanism, providing funding for approved research projects.

Project Implementation Timeline and Reporting Obligations:

Maximum project period is five years.
Annual Research Performance Progress Reports (RPPR) are required for multi-year awards.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for award closeout.

Post-Award Requirements and Compliance Obligations:

Compliance with ClinicalTrials.gov registration and results reporting is required for all clinical trials.
Recipient institutions must ensure all protocols are reviewed by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Compliance with NIH policy for data and safety monitoring for all human biomedical and behavioral intervention studies (clinical trials).
Projects involving investigational therapeutics/devices must operate under a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE).
Adherence to the NIH Grants Policy Statement and relevant federal regulations (e.g., 2 CFR Part 200).
Mandatory Disclosure: Recipients must disclose any violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.

Evaluation Criteria

Applications submitted to this NIH grant are rigorously evaluated for their scientific and technical merit through the NIH peer review system. Reviewers will assign an Overall Impact Score based on several factors, assessing the likelihood of the project to have a sustained, powerful influence on the research field. Scored Review Criteria: These three factors will directly influence the scientific merit and receive separate criterion scores:

Importance of the Research (Significance and Innovation): How significant and innovative is the proposed research? Does it address critical gaps in knowledge or advance scientific understanding in a meaningful way?
Rigor and Feasibility (Approach): How well-designed and rigorous is the proposed research approach? Are the methods, analyses, and experimental design sound and feasible?
Expertise and Resources (Investigator(s) and Environment): Do the investigators possess the necessary experience, qualifications, and collaborative arrangements? Is the research environment suitable for conducting the proposed work, with access to appropriate resources?

Additional Review Criteria (Not Scored, but Impact Overall Score): Reviewers will consider these aspects during evaluation, contributing to the overall impact score, but they do not receive separate numerical scores:

Protections for Human Subjects: Assessment of the adequacy of plans for the protection of human subjects, particularly important given the clinical trial requirement.
Vertebrate Animals: If applicable (though human studies are prioritized, procedures involving animals might be considered in certain contexts, though the NOFO states 'human studies only' for the clinical trial component, so this might be for supporting foundational work, if any, that informs the clinical trial but is not the core focus of the funded project. For this grant, it's explicitly stated preclinical animal studies are not allowed).
Biohazards: Evaluation of potential hazards and proposed protection measures.
Resubmissions: Assessment of the revised application in light of previous reviews.
Renewals: Evaluation of progress made during the previous funding period.
Revisions: Assessment of the appropriateness of any proposed expansion of the project's scope.

Additional Review Considerations (Not Scored, No Impact on Overall Score, but provide context):

Authentication of Key Biological and/or Chemical Resources: Plans for validating resources.
Budget and Period of Support: Evaluation of whether the requested budget and project duration are justified and reasonable for the proposed research.

Competitive Advantage Factors and Quality Thresholds: To stand out, applications should demonstrate: * High Scientific Merit: Strong evidence of significance, innovation, and a rigorous approach. * Alignment with NIAAA Priorities: Research areas of high interest to NIAAA include medications development, behavioral therapies, recovery, translational research, and innovative methods/technologies for AUD treatment. Explicitly addressing these areas will be advantageous. * Focus on Special-Emphasis and Underserved Populations: Proposals addressing health disparities, age, sex, race/ethnicity, co-occurring disorders, military populations, women, adolescents/young adults, and older adults are highly valued. * Strong Team and Environment: Clear demonstration of investigator expertise and access to suitable infrastructure for conducting clinical trials. * Comprehensive Data Management and Sharing Plan: Adherence to the NIH Policy for Data Management and Sharing. Cross-Cutting Themes: While not explicitly scored as separate criteria, the grant's stated interest in addressing issues related to: * Health Disparities * Age * Sex * Race and Ethnicity * Co-occurring disorders * Military populations ...suggests that proposals integrating these considerations into their research design, especially for target populations and potential impact, would be viewed favorably.

Compliance & Special Requirements

Regulatory Compliance Requirements:

Awards are made under the authority of the Public Health Service Act (Sections 301 and 405) and Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
Compliance with the NIH Grants Policy Statement is mandatory for all awards.
Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).

Data Protection and Privacy Regulations:

NIH Data Management and Sharing Policy: When data management and sharing is applicable, recipients must adhere to and implement a Data Management and Sharing Plan. This includes genomic data sharing plans if applicable.
Data and Safety Monitoring Requirements: Essential for all human biomedical and behavioral intervention studies (clinical trials) to ensure participant safety and data integrity.

Environmental and Ethical Standards:

Ethical Conduct: Research involving human subjects requires rigorous protections and IRB/IEC approval. All major changes to ongoing protocols must be reported to NIH.
Biohazards: If applicable, procedures involving biohazards must be evaluated for safety to personnel and environment, with adequate protection proposed.

Intellectual Property Policies:

General NIH policies apply; specific IP clauses are not detailed in this NOFO but will be part of the award terms.

Risk Management and Security Requirements:

Risk Management: Implicit in the data and safety monitoring requirements for human studies. The clinical trial nature demands robust risk assessment and mitigation strategies.
Security: Not explicitly detailed, but implied through compliance with federal regulations and data management policies for sensitive research data.

Unique Aspects, Potential Challenges, or Strategic Opportunities:

Clinical Trial Mandate: This grant requires a clinical trial. Proposals without a clinical trial component will not be reviewed.
Human Studies Only: Preclinical animal studies, prevention trials, and clinical trials in community settings or involving organ-associated diseases are explicitly excluded.
Specific Exclusions: Studies on substances other than alcohol or poly-substance use disorders are not permitted. This is a very targeted grant.
Focus on Underserved Populations: A significant strategic opportunity lies in addressing health disparities and specific populations (e.g., women, adolescents, older adults, those with co-occurring disorders) within the context of AUD treatment and recovery.
Translational Research: Emphasizes bridging basic neuroscience findings to clinical practice.
Innovation in Technology: Encourages the application of new technologies (mobile, web-based, sensors) to improve AUD treatment and data collection.

Cross-Cutting Considerations:

Inclusion: The grant explicitly mentions interest in health disparities, age, sex, race/ethnicity, and co-occurring disorders, highlighting an inclusive approach to AUD research.
Sustainability: Research on how to sustain recovery from AUD is a key area of interest, reflecting a long-term impact perspective.
Mandatory Disclosure: Recipients are required to disclose any potential fraud, bribery, or gratuity violations involving federal awards.
Required Registrations: The necessity of completing multiple federal registrations (SAM, UEI, eRA Commons, Grants.gov) well in advance is a critical pre-application hurdle.
Prior Contact for Large Budgets: Applicants requesting over $500,000 in direct costs must initiate contact with NIH Scientific/Research staff six weeks before submission, which requires early planning.

Grant Details