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Grant Analysis

Purpose & Target

This grant, PAR-25-158, aims to fund research focused on preventing Fetal Alcohol Spectrum Disorders (FASD) by reducing prenatal alcohol exposure, and developing interventions for individuals affected by FASD throughout their lives. It supports biomedical, behavioral, and social sciences research, with a strong preference for applications that include clinical trials. This is a SECTOR-SPECIFIC grant targeting organizations capable of conducting research in the health and social sciences, specifically related to alcohol exposure and developmental disorders. The grant is open to a very broad range of organization types including academic institutions, non-profits, for-profits (including small businesses), and various government entities, both domestic and international. It is a recurring funding opportunity with multiple application cycles available until its expiration date in November 2026, and is a reissue of a previous funding opportunity, indicating continuity in program objectives.

Financial Structure

This grant supports research projects with a phased award mechanism (R61/R33), where funding limits are specified for each phase:

R61 Phase (Years 1-2):
- The combined direct costs for both years may not exceed $350,000.
- No more than $225,000 direct costs may be requested in a single year during this phase.
R33 Phase (Years 3-5):
- The direct costs must not exceed $500,000 per year.

The total project period for both phases combined cannot exceed 5 years. Cost Categories:

Only direct costs are specified for the budget limits. Standard NIH Grants Policy Statement guidelines apply to eligible and ineligible costs, as well as indirect cost policies.
Pre-award costs are allowable as described in the NIH Grants Policy Statement.

Matching Funds and Cost-Sharing:

This funding opportunity does not require cost-sharing or matching funds.

Payment Schedule and Financial Reporting:

Payment mechanisms follow standard NIH grant procedures.
Recipients are required to submit a Research Performance Progress Report (RPPR) annually.
A final RPPR, an invention statement, and the expenditure data portion of the Federal Financial Report are required for grant closeout.

Eligibility Requirements

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

Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 501(c)(3) IRS Status, other than Institutions of Higher Education)
For-Profit Organizations (including Small Businesses and other For-Profit Organizations)
Local Governments (State, County, City or Township, Special District, Federally Recognized Indian/Native American Tribal Governments, and Other Indian/Native American Tribal Governments)
Federal Governments (Eligible Agencies of the Federal Government, U.S. Territory or Possession)
Other organizations such as Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, and Regional Organizations.

International organizations (non-U.S. entities) are explicitly eligible to apply, and foreign components of U.S. organizations are also allowed. There are no specific organizational size or capacity requirements mentioned beyond the general expectation that the Program Director(s)/Principal Investigator(s) (PD/PI(s)) have the necessary skills, knowledge, and resources to conduct the proposed research. Required Registrations: Before submitting your application, your organization must complete and maintain active registrations in the following systems:

System for Award Management (SAM): Requires annual renewal. Foreign organizations need a NATO Commercial and Government Entity (NCAGE) Code to register.
Unique Entity Identifier (UEI): Issued as part of the SAM.gov registration process. The same UEI must be used across all registrations and on the grant application.
eRA Commons: Your organization must register with eRA Commons, and you need at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov:

All registrations can take 6 weeks or more, so it is crucial to start this process well in advance of the application deadline. Failure to register on time is not a valid reason for a late submission. Exclusion Criteria:

Applications focused solely on HIV/AIDS related research topics will not be considered.
Applications proposing animal research only are not responsive; research strategies must include components for clinical translation during the R33 phase of the award.

Application Process

Application Submission:

Electronic Submission: Applications must be submitted electronically through one of the following platforms:
- NIH ASSIST system (online preparation, submission, and tracking).
- An institutional system-to-system (S2S) solution.
- Grants.gov Workspace.
No paper applications will be accepted.

Key Dates and Deadlines: Applications have multiple due dates, all by 5:00 PM local time of the applicant organization. Applicants are strongly encouraged to submit early to allow for corrections. * Latest Application Due Date: 2026-10-19 17:00:00-05:00 (This is the last New/Renewal/Resubmission/Revision due date). * Other due dates include: 2025-02-19, 2025-06-17, 2025-10-17, 2026-02-18, 2026-06-17. * Letter of Intent Due Date: Encouraged 30 days prior to the application due date (not required or binding). * Expiration Date: 2026-11-18 (This is when the funding opportunity expires). Required Documentation and Materials: Applicants must follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, along with specific instructions in this funding opportunity. Key components include: * SF424(R&R) forms: Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, Budget, Subaward Budget. * PHS 398 Cover Page Supplement. * PHS 398 Research Plan: This is crucial and requires specific sections: * Specific Aims: Clearly describe and demarcate aims for both the R61 and R33 phases on a single attachment. R61 aims focus on testing the innovative concept; R33 aims outline the plan based on R61 support. * Research Strategy: Must contain separate, distinct sections for the R61 and R33 phases. The R61 section should include critical, scientifically justified, specific, and feasible experiments. The R33 section should describe the strategy based on anticipated results from the R61 phase. * Milestones: A dedicated 'Milestones' section within the Research Strategy is required. These must be well-described, quantifiable, and scientifically justified objectives for the R61 phase, whose successful completion determines transition to the R33 phase. Transition is not guaranteed. * Preliminary Data: Not required but can be included if available. * Resource Sharing Plan. * Data Management and Sharing Plan (DMS Plan): Required for all research generating scientific data, regardless of direct costs. NIAAA expects specific information including details on research subject (species, sex, cohort size), data types (omics, imaging, biological, phenotypic, etc.), standards for human subject data (alcohol quantity/frequency, demographics), and repositories for non-human subject data. * PHS Human Subjects and Clinical Trials Information form: Required if human subjects research, clinical research, or NIH-defined clinical trials are involved. * Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys). No publications. Support Offered:

Funding: Monetary support through a grant mechanism.

Project Implementation Timeline & Reporting:

R61 Phase: First 2 years of the award, supporting initial technical development and proof-of-principle projects.
R33 Phase: Following 3 years, supporting further development, application, and evaluation of clinical utility to lay the foundation for larger efficacy trials.
Total Project Period: Not to exceed 5 years.
Reporting: Annual Research Performance Progress Reports (RPPR) and a final RPPR, invention statement, and Federal Financial Report at closeout.

Post-Award Requirements:

Compliance with all terms and conditions of the Notice of Award (NoA).
ClinicalTrials.gov Registration and Reporting: Required for certain 'applicable clinical trials'.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval: Required for all protocols involving human subjects.
Data and Safety Monitoring Requirements: Oversight for human biomedical and behavioral intervention studies.
Investigational New Drug (IND) or Investigational Device Exemption (IDE) Requirements: If applicable for clinical research using investigational interventions.
Mandatory Disclosure: Recipients must report violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.

Evaluation Criteria

Applications are evaluated based on their scientific and technical merit through a rigorous NIH peer review system. Reviewers will assign an overall impact score for the entire project, encompassing both the R61 (exploratory/developmental) and R33 (further development/evaluation) phases. Scored Review Criteria: Reviewers will score applications on these three primary factors: * Factor 1. Importance of the Research (Significance and Innovation): This assesses the importance of the scientific problem being addressed and the potential for innovative approaches. For this specific grant, reviewers will emphasize the importance of the scientific problem. * Factor 2. Rigor and Feasibility (Approach): This evaluates the soundness of the proposed research design, methodology, and feasibility of the plan. Reviewers will emphasize the technical feasibility of the research approach and its translation potential into clinical practice (in the R33 phase). * Factor 3. Expertise and Resources (Investigator(s) and Environment): This assesses the qualifications and experience of the research team and the adequacy of the proposed research environment and resources. Additional Review Criteria (Not scored, but impact overall score): Reviewers will consider these aspects: * Protections for Human Subjects: Ensuring ethical treatment and safety of human participants. * Vertebrate Animals: If applicable, the appropriate care and use of vertebrate animals. * Biohazards: Evaluation of significant hazards and proposed protections for research personnel and environment. * Resubmissions/Renewals/Revisions: Evaluation of previous feedback, progress, or proposed scope changes. Additional Review Considerations (Not scored, do not impact overall score):

Authentication of Key Biological and/or Chemical Resources.
Budget and Period of Support: Evaluation of whether the requested budget and duration are justified and reasonable.

For applications involving clinical trials: A proposed clinical trial may be innovative or address important questions/unmet needs. Clinical trials are given the highest priority under this funding opportunity, meaning applications proposing them are more competitive. Innovation and Technological Advancement: The R61 phase aims to support projects testing an innovative concept/hypothesis. The research should clearly link relevant biomedical, psychological, behavioral, or social factors to the prevention or intervention components and their hypothesized mechanism of action. Translation of findings into clinical practice is a key expectation for the R33 phase.

Compliance & Special Requirements

Regulatory Compliance:

Adherence to the NIH Grants Policy Statement.
Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Compliance with all applicable nondiscrimination laws (demonstrated by Assurance of Compliance HHS-690 upon SAM.gov registration).
Adherence to federal statutes and regulations highlighted in the NIH Grants Policy Statement Section 4 (Public Policy Requirements, Objectives and Other Appropriation Mandates).
Compliance with FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements if the project involves investigational therapeutics or devices.

Data Protection and Privacy:

Mandatory Data Management and Sharing Plan (DMS Plan): This plan is crucial and must follow the 2023 NIH Policy for Data Management and Sharing, including specific NIAAA-expected elements. It requires detailing data types, standards (e.g., alcohol quantity/frequency, demographics for human subjects, alcohol exposure paradigm for animal models), and data preservation/access timelines and repositories.

Ethical Standards:

Human Subjects Protection: Projects involving human subjects must ensure adequate protections, including Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval, and adherence to data and safety monitoring requirements for clinical trials.
Research protocols that target or exclude certain populations must have nondiscriminatory justifications related to health, safety, scientific design, or research purpose.

Intellectual Property (IP) Policies:

While not detailed in this document, NIH Grants Policy Statement guidelines regarding intellectual property (e.g., invention reporting) will apply.

Risk Management:

The grant mechanism supports exploratory and developmental research, acknowledging the inherent risks of such endeavors. The phased R61/R33 structure mitigates risk by requiring successful completion of quantifiable R61 milestones for transition to the R33 phase, which is not guaranteed.
The document notes that studies under this mechanism are likely to have small sample sizes, leading to potentially unstable effect size estimates, but obtaining such estimates is still encouraged.

Unique Aspects and Strategic Opportunities:

Phased R61/R33 Mechanism: This unique structure supports research from initial pilot/feasibility studies (R61) to further development and evaluation (R33), providing a pathway for promising exploratory research to mature towards efficacy trials.
Clinical Trial Optional (Highest Priority): Applications proposing clinical trials are given the highest priority, making this a strong opportunity for clinical researchers.
Focus on Translation: There is a clear emphasis on translating research findings into clinical practice.
Addressing Stigmatization: The scope includes designing and evaluating strategies to reduce stigmatization of women who use alcohol, mothers of children with FASD, and individuals with FASD, highlighting a social justice component.
Culturally Sensitive Interventions: Encourages the development and evaluation of interventions that are culturally sensitive, particularly for high-risk, vulnerable, and underserved populations.
Broad Scope of Interventions: Covers various approaches including policy, community-based, health messaging, therapeutic, medication, dietary, parenting skills development, school-based methods, and innovative technologies like telemedicine.

Grant Details