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Grant Analysis

Purpose & Target

The core objective of this grant is to support innovative analysis of existing social science, behavioral, administrative, and neuroimaging data related to substance use behaviors, disorders, prevention, and health service utilization. It explicitly does not allow primary data collection.

Explicit identification of target recipient type and size: Broad, including higher education, non-profits, for-profits (small and large), and various government entities.
SECTOR-SPECIFIC: Health, Research, Public Health, Social Science, Neuroimaging, HIV/AIDS.
Geographic scope and any location requirements: Global, non-U.S. entities and foreign components of U.S. organizations are eligible.
Key filtering criteria for initial grant screening: Must use existing data; primary data collection is strictly prohibited. Focus on substance use and related areas, including HIV. Projects must be distinct from previously funded research using the same data.
Grant frequency and program context: This is a recurring opportunity, a reissue of a previous RFA, offered by the National Institute on Drug Abuse (NIDA) under the National Institutes of Health (NIH).

Financial Structure

Funding Type: Grant (R01 Research Project Grant).
Award Budget: Application budgets are not limited but must reflect the actual needs of the proposed project.
Total Funds Available: NIDA intends to commit $2,000,000 in FY 2026 to award 2-4 applications under this R01, with an additional $2,000,000 for 2-4 applications focused on HIV research, in response to this R01 and the companion R21 RFA (RFA-DA-26-056).
Matching Fund Requirements: No cost sharing is required.
Eligible Costs: Allowable per the NIH Grants Policy Statement. Pre-award costs are allowable as described in the NIH Grants Policy Statement.
Financial Reporting Requirements: Annual Research Performance Progress Report (RPPR), final RPPR, invention statement, and expenditure data portion of the Federal Financial Report (FFR) are required.
Audit Requirements: Projects are subject to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR Part 200).

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 For-Profit Organizations)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal Governments (Federally Recognized and 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 Requirements

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible.
Foreign components, as defined by NIH, are allowed.

Registration Requirements (Mandatory before submission)

Applicant organizations must complete and maintain active registration with:
System for Award Management (SAM) (requires annual renewal).
NATO Commercial and Government Entity (NCAGE) Code (Foreign organizations, in lieu of CAGE code for SAM registration).
Unique Entity Identifier (UEI) (issued via SAM.gov registration; must match all registrations).
eRA Commons (organization must identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account).
Grants.gov (requires active SAM registration).
Program Directors/Principal Investigators (PD(s)/PI(s)) must have an eRA Commons account and affiliate it with the applicant organization.

Project Specific Requirements

Clinical Trial Status: Clinical trials are Not Allowed. Only applications that do not propose clinical trials will be accepted.
Data Collection: Primary (new) data collection (interviews, surveys, focus groups, expert panel feedback, analysis of banked biospecimens) is not allowed.
Research Focus: Proposed research must be distinct from previously/currently funded research using these data and distinct from the primary research under which the data were collected.

Application Process

Application Deadlines and Cycles

Multiple application due dates are available; the latest is December 03, 2027, by 5:00 PM local time of the applicant organization.
Letter of Intent Due Date: 30 days prior to submission due date (not required, but encouraged).
Earliest Start Date: April 2026 (for July 2025 submission), July 2026 (for Dec 2025 submission), April 2027 (for July 2026 submission), July 2027 (for Dec 2026 submission), April 2028 (for July 2027 submission), July 2028 (for Dec 2027 submission).
Expiration Date for NOFO: December 04, 2027.

Application Procedure and Submission

Applications must be submitted electronically via:
NIH ASSIST system.
Institutional system-to-system (S2S) solution.
Grants.gov Workspace.
Applicants are encouraged to submit early to allow time for corrections.
Applications will be evaluated for completeness, compliance, and responsiveness. Incomplete, non-compliant, or nonresponsive applications will not be reviewed.

Required Documentation and Materials

SF424(R&R) 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 Cover Page Supplement, Research Plan.
Resource Sharing Plan (required).
Data Management and Sharing Plan (required for all applications, regardless of direct costs).
Appendix: Limited to blank questionnaires or blank surveys. No publications or other material allowed.
PHS Human Subjects and Clinical Trials Information form (if human subjects involved).
PHS Assignment Request Form.
Foreign Organizations: Must follow NIH Grants Policy Statement and specific procedures for foreign institutions.

Review Process

Scientific peer review by a Scientific Review Group convened by NIDA.
Applications may undergo a selection process where only top applications are discussed and scored.
Second level of review by the National Advisory Council on Drug Abuse.
Funding decisions based on scientific/technical merit, fund availability, and relevance to program priorities.

Post-Award Requirements

Recipients must submit the Research Performance Progress Report (RPPR) annually and financial statements.
A final RPPR, invention statement, and expenditure data are required for closeout.
NIH will review performance based on details and outcomes shared in the RPPR.

Evaluation Criteria

Overall Impact

Reviewers provide an overall impact score reflecting the likelihood of the project to exert 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, or creates a valuable conceptual or technical advance.
Rationale for undertaking the study and rigor of the scientific background (literature/preliminary data) justify the proposed study.
Innovation:
Application of novel concepts, methods, or technologies, or novel use of existing concepts/methods/technologies, to enhance overall impact.

Factor 2: Rigor and Feasibility

Approach (Scientific Quality):
Likelihood of compelling, reproducible findings (rigor).
Ability to execute proposed studies well and within timeframes (feasibility).
Rigor:
Potential to produce unbiased, reproducible, robust data.
Rigor of experimental design and appropriateness of controls.
Sufficient and well-justified sample size.
Quality of plans for analysis, interpretation, and reporting of results.
Adequate plans to address relevant biological variables (e.g., sex or age) in design, analysis, and reporting.
For human subjects: rigor of intervention, justified outcome variables, generalizability/relevance, appropriate/diverse sample, adequate inclusion plans.
Feasibility:
Proposed approach is sound and achievable.
Plans to address emerging problems/challenges.
For human subjects: adequacy and feasibility of recruitment/retention plan for target population, likelihood of achieving enrollment based on age, race, ethnicity, and sex.
For clinical trials (though not allowed for this R01, general NIH criterion): feasible study timeline and milestones.

Factor 3: Expertise and Resources

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

Additional Review Criteria (Considered, but not scored)

Protections for Human Subjects:
Justification for involvement and proposed protections against research risk.
Adequacy of protection, potential benefits, importance of knowledge, data/safety monitoring.
Vertebrate Animals (if applicable):
Description of procedures, justifications for use, interventions to minimize discomfort, justification for euthanasia.
Biohazards (if applicable):
Assessment of hazardous materials/procedures and proposed adequate protection.
Resubmissions/Renewals/Revisions (if applicable):
Evaluation of current application, progress made, or appropriateness of scope expansion.
Authentication of Key Biological and/or Chemical Resources:
Brief plans for identifying and ensuring validity of resources.
Budget and Period of Support:
Justification and reasonableness of budget and requested period relative to proposed research.

Compliance & Special Requirements

Regulatory Compliance

Adherence to all provisions in 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 (requires HHS-690 Assurance of Compliance).
Compliance with federal statutes and regulations relevant to federal financial assistance (e.g., NIH GPS Section 4).

Data Protection and Security

Data Management and Sharing Plan: Must be consistent with the 2023 NIH Policy for Data Management and Sharing; recipients must implement the approved plan.
Cybersecurity: For recipients/subrecipients with ongoing access to HHS information or operational technology systems and handling PII/PHI, plans and procedures modeled after the NIST Cybersecurity framework are required.

Ethical and Research Standards

Human Subjects Protection: For research involving human subjects, evaluation of justification, protection against risks, potential benefits, knowledge importance, and data/safety monitoring.
Vertebrate Animals: Requirements for procedures, justifications, minimizing discomfort, and euthanasia methods.
Biohazards: Evaluation of hazardous materials/procedures and proposed protections.
Rigor and Reproducibility: Projects must demonstrate potential for unbiased, reproducible, robust data. Plans to address biological variables (sex, age) are required.
Risk for Spurious Findings: Applicants strongly encouraged to consider and address the risk for spurious findings when conducting multiple analyses and/or using large datasets.

Intellectual Property

Not explicitly detailed, but NIH policies (e.g., invention reporting) apply.

Technology Specifications

Health IT: If award funding involves implementing, acquiring, or upgrading health IT, it must meet standards in 45 CFR part 170, Subpart B. If for eligible clinicians, certified under ONC Health IT Certification Program.

Special Considerations and Focus Areas

This NOFO strictly prohibits primary data collection.
Encourages analysis of specific existing datasets (e.g., ABCD Study, PATH Study, Human Connectome Project, NAHDAP, NIDA Data Share, various HIV/AIDS focused datasets).
Applicants using ABCD data must pre-register statistical analysis plans with a publicly accessible registry or as a registered report.
Strong encouragement for innovative methods: big data analytics, computational modeling, artificial intelligence (machine learning, natural language processing, neural networks, deep learning, large language models), and novel visualization tools.
Focus on real-world impact: Findings should be translatable to prevention intervention development/testing, services, policy, or other real-world impact.
Emphasis on health disparities: Encourages analyses using data from understudied populations, examining licit/illicit substances affecting HIV risk/outcomes, and research leading to improved outcomes and reductions in HIV- and substance use-related disparities.
Alignment with NIDA's HIV priority areas is strongly encouraged.

Grant Details