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Grant Analysis

Purpose & Target

This grant aims to accelerate substance use research by funding innovative analysis of existing social science, behavioral, administrative, and neuroimaging data. It focuses on understanding the etiology, epidemiology, prevention, and treatment of substance use and related disorders, including HIV. The grant targets research institutions and organizations with strong data analysis capabilities. - Target recipient type: Research institutions, non-profits, for-profit organizations, and government entities capable of sophisticated data analysis. - Target size: Not explicitly limited by size; open to various organizational structures. - SECTOR-SPECIFIC: Healthcare, Public Health, Social Science Research. - Geographic scope: Domestic (U.S.) and non-U.S. (Foreign) entities are eligible to apply. - Key filtering criteria: Focus on existing data analysis, no primary data collection, and relevance to substance use/HIV. - Grant frequency: Recurring (reissue of a previous RFA) with multiple application cycles through December 2027. - Program context: Part of NIH's broader effort to advance knowledge and approaches for substance use prevention, diagnosis, and treatment.

Financial Structure

Budget range: The combined budget for direct costs for the two-year project period may not exceed $275,000.
Maximum funding per year: No more than $200,000 may be requested in any single year.
Currency: USD (United States Dollar).
Eligible costs: Direct costs as defined by NIH Grants Policy Statement.
Ineligible costs: Primary data collection is explicitly excluded.
Matching fund requirements: This funding opportunity does not require cost sharing.
Indirect cost policies: Not explicitly detailed in this NOFO but subject to NIH Grants Policy Statement guidelines.
Financial reporting requirements: Recipients are required to submit financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting.

Eligibility Requirements

Organization Type

Eligible: Higher Education Institutions (Public/State Controlled, Private), Nonprofits (with/without 501(c)(3) IRS Status), For-Profit Organizations (Small Businesses, Other For-Profit Organizations), Local Governments (State, County, City/Township, Special District), Indian/Native American Tribal Governments (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, Faith-based or Community-based Organizations, Regional Organizations, Non-domestic (non-U.S.) Entities/Foreign Organizations).

Geographic Location

U.S. entities are eligible.
Non-domestic (non-U.S.) Entities (Foreign Organizations) are also eligible to apply.

Registrations and Certifications

Applicant organizations must complete and maintain active registrations in:
- System for Award Management (SAM) - requires annual renewal.
- NATO Commercial and Government Entity (NCAGE) Code - required for Foreign organizations (in lieu of CAGE).
- Unique Entity Identifier (UEI) - issued as part of SAM.gov registration.
- eRA Commons - must be registered with at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
- Grants.gov - requires active SAM registration.
PD(s)/PI(s) must have an eRA Commons account and affiliate it with the applicant organization.
Registration can take 6 weeks or more; early registration is strongly advised.

Project Focus

Applications must propose innovative analysis of existing social science, behavioral, administrative, and neuroimaging data.
Primary data collection (e.g., interviews, surveys, focus groups, analysis of banked biospecimens for which data are not already available) is not allowed and will result in applications being non-responsive.

Application Process

Application Package Access

Access forms through NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.

Key Dates

Open Date (Earliest Submission Date): June 17, 2025
Letter of Intent Due Date(s): 30 days prior to each application due date (e.g., June 17, 2025 for July 17, 2025 submission).
Application Due Dates:
- July 17, 2025
- December 03, 2025
- July 17, 2026
- December 03, 2026
- July 15, 2027
- December 03, 2027 (Latest deadline)
All applications are due by 5:00 PM local time of the applicant organization.
Expiration Date of NOFO: December 04, 2027.

Submission Process

Applications must be submitted electronically via Grants.gov.
Track application status in eRA Commons.
Ensure all required registrations (SAM, UEI, eRA Commons, Grants.gov) are complete before the submission deadline.
Applicants are encouraged to submit early to allow for corrections.
Errors must be corrected and a changed/corrected application resubmitted by the due date.

Required Documentation and Materials

Follow instructions in the Research (R) Instructions in the 'How to Apply - Application Guide' and any program-specific instructions in this NOFO.
Specific forms: SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R or Modular Budget, R&R Subaward Budget, PHS 398 Cover Page Supplement, PHS 398 Research Plan, PHS Human Subjects and Clinical Trials Information, PHS Assignment Request Form.
Resource Sharing Plan: Required.
Data Management and Sharing Plan: Required for all applications that generate scientific data.
Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys). No publications or other material.

Pre-application Requirements

Letter of Intent (LOI) is optional but encouraged 30 days prior to application due date. Should include proposed activity title, PD(s)/PI(s) name/contact, key personnel, institutions, and funding opportunity number.

Review Process and Timeline

Scientific Merit Review: Approximately 3-4 months after application due date (e.g., October 2027 for Dec 2027 submission).
Advisory Council Review: Approximately 2-3 months after Scientific Merit Review (e.g., January 2028 for Dec 2027 submission).
Earliest Start Date: Approximately 2-3 months after Advisory Council Review (e.g., April 2028 for Dec 2027 submission).
Applications evaluated for completeness and compliance by Center for Scientific Review, and responsiveness by NIDA. Incomplete/non-compliant applications will not be reviewed.

Post-Award Requirements

Reporting: Annual Research Performance Progress Reports (RPPR) and financial statements are required. A final RPPR, invention statement, and expenditure data are required for closeout.
Data Management and Sharing: Required to implement the approved Data Management and Sharing Plan.
Institutional Review Board (IRB) / Independent Ethics Committee (IEC) Approval: Recipient institutions must ensure protocols are reviewed.
Compliance: Adherence to Federal-wide and HHS-specific policy requirements, including 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards), NIH Grants Policy Statement, and non-discrimination laws. Successful recipients agree to develop plans for cybersecurity (modeled after NIST framework) if having access to HHS systems/data.

Evaluation Criteria

Overall Impact

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

Factor 1: Importance of the Research

Significance: Evaluates whether the proposed research addresses an important knowledge gap, solves a critical problem, or creates a valuable conceptual/technical advance within the field.
Innovation: Assesses the extent to which the project applies novel concepts, methods, or technologies, or uses existing ones in new ways, to enhance overall impact. Note: Innovation is important, but a project not applying novel concepts can still be of critical importance.

Factor 2: Rigor and Feasibility

Rigor: Evaluates the potential to produce unbiased, reproducible, and robust data. Considers rigor of experimental design, appropriate controls, justified sample size, and quality of plans for analysis, interpretation, and reporting. Adequacy of plans to address relevant biological variables (e.g., sex, age) in design, analysis, and reporting.
Feasibility: Evaluates if the proposed approach is sound and achievable within the proposed timeframes. Assesses plans to address emerging problems. For studies with human subjects, evaluates adequacy and feasibility of recruitment/retention plans for the target population.

Factor 3: Expertise and Resources

Investigator(s): Evaluates the demonstrated background, training, and expertise of the investigator(s) relevant to the proposed work. For multiple PIs, assesses the quality of the leadership plan.
Environment: Evaluates whether institutional resources are appropriate for successful execution of the proposed work.

Additional Review Considerations (No separate scores, but inform overall impact score)

Protections for Human Subjects: Justification for involvement, adequacy of protection against risks, potential benefits, importance of knowledge to be gained, and data/safety monitoring.
Vertebrate Animals (if applicable): Justification for use, appropriateness of species, interventions to minimize discomfort, and justification for euthanasia method.
Biohazards (if applicable): Assessment of significant hazards and proposed protection.
Authentication of Key Biological and/or Chemical Resources.
Budget and Period of Support: Evaluation of reasonableness and justification in relation to proposed research.

Compliance & Special Requirements

Data Management and Sharing

Mandatory Data Management and Sharing Plan: All applications generating scientific data must submit a plan, regardless of direct costs requested. This plan must be implemented upon approval.
Existing Data Emphasis: The core of this grant is the innovative analysis of existing data. Proposed research must be distinct from previously/currently funded research using these same datasets.
Primary Data Collection Exclusion: Applications including any primary (new) data collection (interviews, surveys, focus groups, analysis of banked biospecimens for which data are not already available) are not responsive and will not be reviewed.

Ethical and Regulatory Compliance

Human Subjects Protections: For research involving human subjects, comprehensive plans for protection, risk mitigation, and data safety monitoring are required and evaluated.
Vertebrate Animals: If applicable, detailed justifications and plans for animal welfare must be provided.
Biohazards: If applicable, adequate protection measures must be proposed.
Mandatory Disclosure: Recipients must report any violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.
Health IT Standards: If award funding involves health IT implementation, acquisition, or upgrade, recipients must use health IT meeting specific standards (45 CFR part 170, Subpart B) and certified under the ONC Health IT Certification Program, where applicable.
Cybersecurity: Recipients with ongoing access to HHS systems or PII/PHI must develop cybersecurity plans and procedures modeled after the NIST Cybersecurity framework.

Research Methodology & Risk

Spurious Findings: Applicants are strongly encouraged to consider the risk for spurious findings when conducting multiple analyses or using large datasets, and to address this concern in the application.
Effect Size Reporting: Applicants are strongly encouraged to calculate and report effect size (e.g., percentage of variance explained) in addition to statistical significance, whenever possible.
Pre-registration: Applicants using the ABCD data set (and others where appropriate) are required to include a plan to pre-register plans for statistical analyses with a publicly accessible registry or as a registered report at a journal.

Grant Details