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Grant Analysis

Purpose & Target

The core objective of this grant is to support planning studies that are scientifically necessary and sufficient to inform the design and future implementation of Phase II, III, or IV clinical trials focused on HIV prevention among alcohol-impacted populations.
This grant targets research institutions, non-profits, for-profit organizations, and government entities of various sizes capable of conducting rigorous research.
It is SECTOR-SPECIFIC, focusing primarily on Healthcare (HIV/AIDS, Alcohol Use Disorder) and Social Sciences/Behavioral Research.
The geographic scope is Domestic (US, with emphasis on HIV/AIDS 'hot spots' like the US South) and International.
Key filtering criteria include a focus on HIV prevention, involvement of alcohol-impacted populations, and the explicit aim of informing a clinical trial.
This is a recurring grant opportunity, noted as a reissue of a previous announcement (PAS-23-172), indicating ongoing program context.

Financial Structure

Budget Range: The total project period budget may not exceed $450,000 direct cost.
Annual Budget Limitation: No more than $225,000 direct cost can be requested in a single year.
Total Program Funding: NIH intends to fund an estimate of 2-4 awards, corresponding to a total of $1,500,000 for fiscal year 2025.
Grant Type: This is a financial assistance mechanism provided as a Grant.
Matching Fund Requirements: No cost sharing is required for this funding opportunity.
Eligible Costs: Direct costs are explicitly mentioned as the primary funding mechanism. Pre-award costs are allowable as per NIH Grants Policy Statement.
Financial Reporting: Recipients are required to submit an annual Research Performance Progress Report (RPPR) and financial statements.
Closeout Requirements: A final RPPR, invention statement, and expenditure data are required for award closeout.
Indirect Cost Policies: Not explicitly detailed in the NOFO, but subject to standard NIH Grants Policy Statement terms.

Eligibility Requirements

Organizational Eligibility

Eligible Organization Types:
- Higher Education Institutions: Public/State Controlled, Private
- Nonprofits: With or without 501(c)(3) IRS Status
- For-Profit Organizations: Small Businesses, Other than Small Businesses
- Local Governments: State, County, City or Township, Special District, Federally Recognized Indian/Native American Tribal Governments, Other Indian/Native American Tribal Governments
- Federal Governments: Eligible Agencies
- Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations, Non-domestic (non-U.S.) Entities (Foreign Organizations), and Non-domestic components of U.S. Organizations.

Geographic Requirements

Organizations from Non-domestic (non-U.S.) Entities (Foreign Organizations) and U.S. Territories or Possessions are eligible to apply.

Registration Requirements (Mandatory before application submission)

System for Award Management (SAM): Active registration is required, renewable at least annually. Foreign organizations need a NATO Commercial and Government Entity (NCAGE) Code to register.
Unique Entity Identifier (UEI): Issued as part of SAM.gov registration; must be consistent across all registrations and the grant application.
eRA Commons: Organizations must register and identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov: Active SAM registration is required to complete Grants.gov registration.

Principal Investigator (PD/PI) Requirements

eRA Commons Account: All PD(s)/PI(s) must have an eRA Commons account, affiliated with the applicant organization.
Skills and Knowledge: Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to apply.
Multiple PDs/PIs: Institutions/organizations may propose multiple PDs/PIs following specific NIH policy.

Exclusion Criteria

Applications will not be considered responsive and will not be reviewed if they:
- Focus only on patients in HIV care but not on 'Treatment as Prevention'.
- Include vertebrate animals or focus on developing animal models.
- Involve basic behavioral or biological studies that do not inform translation to intervention activities.

Application Process

Application Deadlines and Submission

Open Date (Earliest Submission Date): April 07, 2025
Application Due Dates:
- May 07, 2025 (AIDS - New/Renewal/Resubmission/Revision)
- September 07, 2025 (AIDS - New/Renewal/Resubmission/Revision)
- January 07, 2026 (AIDS - New/Renewal/Resubmission/Revision)
- May 07, 2026 (AIDS - New/Renewal/Resubmission/Revision)
Submission Time: All applications are due by 5:00 PM local time of the applicant organization.
Expiration Date: May 08, 2026
Letter of Intent (LOI) Due Date: 30 days before the application due date (optional, but encouraged).

Application Procedure

Electronic Submission: Applications must be submitted electronically through ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Required Registrations: Applicants must complete and maintain active registrations with SAM.gov, Unique Entity Identifier (UEI), eRA Commons, and Grants.gov prior to submitting the application. Allow 6 weeks or more for registration.
PD/PI eRA Commons ID: All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form.
Early Submission: Applicants are encouraged to submit early to allow time for corrections.
On-time Submission: Applications that miss the due date and time will be considered late.
Post-Submission Materials: Applicants must follow NIH policy for post-submission materials.

Required Documentation and Materials

Application Forms Package: Accessed via ASSIST, Grants.gov Workspace, or institutional S2S.
Standard Forms (SF424(R&R) series):
- Cover
- Project/Performance Site Locations
- Other Project Information
- Senior/Key Person Profile
- R&R or Modular Budget
- R&R Subaward Budget
PHS Forms (398 series):
- Cover Page Supplement
- Research Plan (including Resource Sharing Plan, Data Management and Sharing Plan, and limited Appendix materials)
- Human Subjects and Clinical Trials Information (if applicable)
- Assignment Request Form

Project Implementation Timeline

Grant Duration: The project period is limited to 3 years.

Reporting Obligations

Annual Reporting: Research Performance Progress Report (RPPR) and financial statements are required annually.
Closeout Reporting: A final RPPR, invention statement, and expenditure data are required for award closeout.
ClinicalTrials.gov: If the award includes clinical trials, registration and results submission are required.

Application Assistance Availability

eRA Service Desk: For system questions (ASSIST, eRA Commons, errors).
General Grants Information: For application instructions and processes.
Grants.gov Customer Support: For Grants.gov registration and Workspace issues.
Scientific/Research Contact(s): For questions about the scientific scope and priorities of the NOFO.
Financial/Grants Management Contact(s): For questions regarding budget and financial policies.

Evaluation Criteria

Overall Impact

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

Scored Review Criteria

Factor 1. Importance of the Research (Significance and Innovation):
- The potential for the proposed research to advance understanding and approaches in HIV prevention among alcohol-impacted populations.
- Novelty of the scientific concepts, approaches, or methodologies.
Factor 2. Rigor and Feasibility (Approach):
- Soundness of the research design, methods, and analyses.
- Adequacy of plans for addressing potential problems and alternative strategies.
- Sufficiency of the proposed research to inform the planning of a future clinical trial.
- Integration of innovative, state-of-the-art measurement and analytic approaches (e.g., biomarkers, passive alcohol sensors, mHealth).
- Encouragement of pragmatic trials and adaptive designs.
Factor 3. Expertise and Resources (Investigator(s) and Environment):
- Qualifications, experience, and leadership of the PD(s)/PI(s) and key personnel.
- Adequacy and appropriateness of the institutional environment and facilities for the proposed research.
- Availability of necessary resources and collaborative arrangements.

Additional Review Criteria (Considered but not separately scored)

Protections for Human Subjects: Adequacy of plans for human subject protection.
Vertebrate Animals: Evaluation of procedures, justifications, and minimization of discomfort (if applicable, though generally excluded for this NOFO).
Biohazards: Assessment of hazardous materials/procedures and proposed protections.
Resubmissions: Evaluation of the revised application.
Renewals: Evaluation of progress from the previous funding period.
Revisions: Evaluation of the appropriateness of proposed scope expansion.

Additional Review Considerations (Considered but not scored)

Authentication of Key Biological and/or Chemical Resources: Plans for validating resources.
Budget and Period of Support: Justification and reasonableness of the budget and requested project duration in relation to the proposed research.

Funding Decisions

Decisions are based on:
- Scientific and technical merit determined by peer review.
- Availability of funds.
- Relevance of the proposed project to NIAAA program priorities (e.g., health disparities, community-based participatory research, specific high-risk groups).

Compliance & Special Requirements

Regulatory and Legal Compliance

Federal Regulations: Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) and 42 CFR Part 52.
NIH Grants Policy Statement: Adherence to all terms and conditions outlined in the NIH Grants Policy Statement.
Non-discrimination Laws: Recipients must comply with all applicable non-discrimination laws, as agreed upon during SAM.gov registration, and submit an Assurance of Compliance (HHS-690).
Mandatory Disclosure: Recipients must disclose any violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.

Data Management and Security

Data Management and Sharing Plan (DMS Plan): Required for all applications planning research that generates scientific data, consistent with the 2023 NIH Policy.
Health IT Standards: If acquiring or upgrading health IT, it must meet standards and implementation specifications adopted in 45 CFR part 170, Subpart B.
Certified Health IT: For eligible clinicians in ambulatory settings or hospitals, use health IT certified under the ONC Health IT Certification Program.
Cybersecurity: Recipients with ongoing access to HHS information systems or who handle Personally Identifiable Information (PII) or Personal Health Information (PHI) obtained from HHS must develop plans and procedures modeled after the NIST Cybersecurity framework.

Research and Ethical Standards

Human Subjects Protection: Strict adherence to protections for human subjects. Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for all protocols.
Data and Safety Monitoring: Required for all NIH-funded human biomedical and behavioral intervention studies (clinical trials) to ensure participant safety and data integrity.
Investigational Products: Clinical research involving investigational therapeutics, vaccines, or devices must be performed under an FDA investigational new drug (IND) or investigational device exemption (IDE), if applicable.

Unique Aspects and Strategic Considerations

Planning Grant (R34): This mechanism is specifically for obtaining information necessary and sufficient to plan a future clinical trial, not to conduct the full trial itself. The R34 research must directly inform the final development of a clinical trial.
Clinical Trials Optional: Applicants can propose projects that do or do not include clinical trials; however, the R34 specifically focuses on planning for a future trial.
Focus on High-Risk Groups: Strong encouragement for research targeting specific high-risk groups for alcohol-related HIV/AIDS acquisition/transmission (e.g., MSM of color, commercial sex workers, HIV-serodiscordant couples, pregnant women living with HIV, victims of trauma/violence, individuals newly-released from incarceration).
Syndemic Approach: Encourages addressing the role of critical health disparities by incorporating co-occurring disorders and contributory conditions like intimate partner violence, sexual assault, homelessness, discrimination, and stigma.
Community-Based Participatory Research: Embraces a partnership approach involving community members, organizational representatives, and researchers.
Innovation: Encourages innovative measurement, analytic approaches, communication strategies, and technological approaches (e.g., mHealth).
Risk Tolerance: While focused on planning, the grant acknowledges and expects risk management in human subjects research and data handling.
Geographic Priority: Encourages research congruent with the 'Ending the Epidemic' (EHE) strategic plan, particularly in US HIV/AIDS 'hot spots' like the US South.

Grant Details