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Grant Analysis

Purpose & Target

The Cutting-Edge Basic Research Awards (CEBRA) aim to foster highly innovative or conceptually creative basic research that advances understanding of substance use disorders (SUDs). It specifically targets high-risk, high-impact projects that can transform SUD research by developing revolutionary techniques/methods or testing innovative hypotheses with scant preliminary data. - Target recipients: Investigators with experience in SUD-relevant research and those from other fields seeking to establish innovative SUD programs. - SECTOR-SPECIFIC: Substance Use Disorders Research (HEALTHCARE sector). - Geographic scope: Organizations and individuals in the US and non-US entities (foreign organizations) are eligible. - Key filtering criteria: Focus on SUDs, highly innovative, transformative basic research, early-stage projects (R21 mechanism). - Grant frequency: Recurring with multiple application deadlines through August 2027. Part of NIDA's high-priority research portfolio.

Financial Structure

Award budget for direct costs: Combined budget may not exceed $275,000 over the two-year project period.
Maximum annual direct costs: No more than $150,000 may be requested in any single year.
Minimum funding amount: Not specified.
Cost sharing requirements: This funding opportunity does not require cost sharing.
Eligible costs: Direct costs related to the proposed research. Pre-award costs are allowable as described in the NIH Grants Policy Statement.
Financial reporting requirements: Recipients are required to submit financial statements as required by the NIH Grants Policy Statement.

Eligibility Requirements

Organizational Eligibility

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: 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 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).

Individual Eligibility (Program Director/Principal Investigator)

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research.

Registration Requirements (Mandatory for Applicant Organizations)

System for Award Management (SAM): Active registration required, renewed at least annually. Includes assignment of a Commercial and Government Entity (CAGE) Code.
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 SAM.gov registration; must be used for all registrations and on the grant application.
eRA Commons: Registration required; organizations must identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account.
Grants.gov: Active SAM registration is a prerequisite.

Registration Requirements (Mandatory for Program Director/Principal Investigator)

eRA Commons Account: All PD(s)/PI(s) must have an eRA Commons account, affiliated with the applicant organization.

Exclusion Criteria

Applications that include alcohol alone as a substance of use/misuse are not responsive and will not be reviewed.
Duplicate or highly overlapping applications are not accepted under review at the same time (e.g., a new application submitted before summary statement from overlapping application).
Cost sharing is not required.

Application Process

Key Dates and Deadlines

Open Date (Earliest Submission Date): February 10, 2025
Letter of Intent Due Date(s): 30 days prior to the application due date (not binding, but encouraged).
Application Due Dates (by 5:00 PM local time of applicant organization):
March 10, 2025
August 12, 2025
March 10, 2026
August 5, 2026
March 10, 2027
August 11, 2027 (Latest deadline)
Expiration Date: August 12, 2027

Application Submission

Submission Format: Electronic only; paper applications will not be accepted.
Submission Platforms: NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Tracking: After Grants.gov submission, applicants must track application status in eRA Commons.
Corrections: Applicants are encouraged to submit early to allow time for corrections by the due date. Errors must be corrected and a changed/corrected application submitted by the deadline.

Required Documentation and Materials

Follow instructions in the Research (R) Instructions in the How to Apply - Application Guide unless otherwise specified in this NOFO.
SF424(R&R) Forms: Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R or Modular Budget, R&R Subaward Budget.
PHS 398 Forms: Cover Page Supplement, Research Plan (including specific instructions on addressing potential to transform/advance SUD research and breaking new ground), Human Subjects and Clinical Trials Information (if applicable).
Resource Sharing Plan: Required.
Data Management and Sharing Plan: Required for all research generating scientific data, regardless of direct cost amount.
Appendix: Limited materials allowed; no publications or other material except blank questionnaires/surveys.
PHS Assignment Request Form: Required.

Review Process

Applications are evaluated for completeness and compliance by the Center for Scientific Review and responsiveness by NIDA.
Scientific and technical merit review by a Scientific Review Group convened by NIDA.
Applications receive a written critique.
Only top-scoring applications (generally top half) may be discussed and assigned an overall impact score.
Appeals of initial peer review are not accepted.
Second level of review by the appropriate national Advisory Council or Board.
Funding decisions consider scientific merit, availability of funds, and relevance to program priorities.

Post-Award Requirements

Reporting: Annual Research Performance Progress Report (RPPR) and financial statements are required.
Closeout: A final RPPR, invention statement, and expenditure data are required for closeout.
ClinicalTrials.gov: If applicable, the 'responsible party' must register and submit results information for certain 'applicable clinical trials'. NIH expects registration and results reporting for all trials.
IRB/IEC Approval: Recipient institutions must ensure all protocols are reviewed by their IRB or Independent Ethics Committee.
Data and Safety Monitoring: Required for all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials).

Evaluation Criteria

Applications are evaluated for scientific and technical merit through the NIH peer review system, specifically by a Scientific Review Group convened by NIDA. Reviewers provide an overall impact score reflecting the likelihood of the project exerting a sustained, powerful influence on the research field. Key Review Factors (Scored Independently)

Factor 1: Importance of the Research
Significance: Evaluate the importance of the proposed research in advancing knowledge or solving critical problems within the SUD field. Assess the rationale and rigor of the scientific background.
Innovation: Evaluate the extent to which the proposed work applies novel concepts, methods, or technologies, or uses existing ones in new ways, to enhance overall impact.
NOFO-Specific: Evaluate the potential to transform understanding or markedly advance SUD research. Assess if the project breaks new ground, develops new tools/technologies, or extends discoveries into new directions/applications.
Factor 2: Rigor and Feasibility
Rigor: Evaluate the potential for unbiased, reproducible, robust data, including experimental design, controls, sample size justification, and plans for analysis/reporting. Assess plans to address biological variables (sex, age).
Feasibility: Evaluate if the proposed approach is sound and achievable within the proposed timelines. For less certain feasibility, assess if potential for major advances balances the uncertainty. For human subjects, evaluate recruitment/retention plans for appropriate diversity.
Factor 3: Expertise and Resources
Investigator(s): Evaluate the background, training, and expertise of the investigator(s) for the proposed work. For multiple PIs, assess the quality of the leadership plan.
Environment: Evaluate whether institutional resources are appropriate to ensure successful execution.

Additional Review Criteria (Considered, but not separately scored)

Protections for Human Subjects: Justification for involvement, adequacy of protection against risks, potential benefits, importance of knowledge to be gained, data and safety monitoring (for clinical trials).
Vertebrate Animals: Description of procedures, justification for animal use vs. alternatives, interventions to minimize discomfort, and justification for euthanasia method if not consistent with AVMA guidelines.
Biohazards: Assessment of hazardous materials/procedures and proposed protections.
Resubmissions: The full application as presented is evaluated.

Additional Review Considerations (Not scored, do not impact overall score)

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 the budget and requested support period in relation to the research.

Compliance & Special Requirements

Regulatory Compliance

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described 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; assurance of compliance (HHS-690) must be submitted.
Compliance with all federal statutes and regulations relevant to federal financial assistance, including public policy requirements.

Data and Privacy Regulations

Data Management and Sharing Plan: Required for all research that results in the generation of scientific data.
Genomic Data Sharing Plans: Implementation changes for plans included with applications due on or after January 25, 2023.

Ethical Standards

Human Subjects Protections: For research involving human subjects, compliance with 45 CFR Part 46 and specific review criteria for protections is mandatory. Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required.
Vertebrate Animals: Compliance with guidelines for the involvement of live vertebrate animals is required.
Biohazards: Adequate protection measures must be proposed for hazardous materials or procedures.

Technical and Risk Management

Clinical Trials: Projects may or may not propose clinical trials; if proposing, they must adhere to specific NIH guidelines and potentially FDA IND/IDE requirements.
Study Design: For group-based interventions, appropriate methods for analysis and sample size estimation are warranted.
Risk Tolerance: The program supports 'high-risk' research, implying a tolerance for projects with less preliminary data but high potential impact.

Special Considerations

Focus on Innovation: Emphasis is on 'highly innovative' or 'conceptually creative' research that can 'transform' current thinking or 'develop revolutionary techniques'. It is explicitly not intended for incremental research.
Project Scope: R21 mechanism supports early, first stages of development with little or no preliminary data; not intended for large-scale undertakings or supplementing ongoing research.
Substance Use Disorders (SUDs): Research must be related to the etiology, pathophysiology, prevention, or treatment of SUDs. Applications solely focused on alcohol are non-responsive.
Mandatory Disclosures: Recipients must disclose any federal criminal law violations involving fraud, bribery, or gratuity potentially affecting the federal award.

Grant Details