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Grant Analysis

Purpose & Target

This funding opportunity, PAR-25-239, aims to support investigator-initiated observational studies or biomarker validation studies. These studies must involve either the prospective (future) collection of data or biological samples (biospecimens), or the continued analysis of data/biospecimens from previous research funded by the National Institute of Dental and Craniofacial Research (NIDCR). This grant is SECTOR-SPECIFIC, focusing primarily on research related to dental, oral, and craniofacial health and diseases. The target recipients are diverse research organizations, including academic institutions, non-profits, various government entities, and even small businesses, located within the United States. Foreign organizations cannot directly apply, but foreign components (e.g., international collaborators) can be part of a U.S. organization's application. This is a recurring funding opportunity, being a reissue of a previous program. Its core objective is to generate high-quality data to improve health outcomes in its specific focus areas.

Financial Structure

This grant utilizes a Cooperative Agreement funding mechanism, which means the National Institutes of Health (NIH) will have substantial scientific and programmatic involvement in the project, working closely with the award recipient. Budget Details

Budget Range and Limitations: There are no specified maximum or minimum funding amounts for individual awards. Applicants should propose a budget that accurately reflects the actual needs of their proposed project. The number of awards made is contingent on NIH appropriations.
Direct Costs over $500,000: If your application requests $500,000 or more in direct costs in any single year (excluding consortium F&A costs), you must contact an NIDCR Scientific/Research Contact at least eight weeks before your application submission date. Failure to do so may result in your application not being reviewed.

Cost Sharing and Co-financing

Cost Sharing: This funding opportunity does NOT require cost sharing (meaning, you are not obligated to contribute a percentage of the total project costs from non-federal sources).
Outsource Costs: If other funding sources (non-NIH) will contribute to the project's costs, these contributions must be clearly detailed in your budget justification. However, these are considered 'outsource costs' and do NOT count as cost sharing.

Eligible and Ineligible Costs

All NIH awards are subject to the terms, conditions, and cost principles outlined in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1.

Financial Reporting

Recipients will be required to submit annual Research Performance Progress Reports (RPPR) and financial statements as per NIH guidelines.
A final RPPR, invention statement, and expenditure data are required for the closeout of the award.

Eligibility Requirements

To be eligible for this grant, your organization must meet specific criteria and be registered with federal systems. Eligible Organization Types This grant is open to a wide range of organizations, including: * Higher Education Institutions: Both public and private universities and colleges. * Nonprofits: Organizations with or without 501(c)(3) IRS status. * For-Profit Organizations: This includes Small Businesses and other for-profit entities. * Local Governments: State, county, city or township governments, special district governments, and both Federally Recognized and Other Indian/Native American Tribal Governments. * Federal Governments: Eligible agencies of the U.S. Federal Government and entities in U.S. Territories or Possessions. * Other: This category includes 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, and Regional Organizations. Geographic Location

Your organization must be based in the United States.
Foreign (non-U.S.) organizations are NOT eligible to apply directly.
However, foreign components (meaning parts of the project carried out in a foreign country by a foreign institution, organization, or person) are allowed as part of a U.S. organization's application.

Required Registrations All applicant organizations must complete and maintain active registrations in the following systems before submitting their application. This process can take six weeks or more, so plan ahead: * System for Award Management (SAM): Requires annual renewal. * NATO Commercial and Government Entity (NCAGE) Code: Required for foreign organizations to register in SAM (though foreign organizations can't apply for this specific grant, this applies if they are components of a U.S. application). * Unique Entity Identifier (UEI): Issued through the SAM.gov registration process. * eRA Commons: Your organization needs an eRA Commons account, and at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account must be linked. * Grants.gov: Requires an active SAM registration to complete. Individual Eligibility (Program Director/Principal Investigator)

Any individual with the necessary skills and resources to lead the proposed research can serve as a PD/PI.
All PD(s)/PI(s) must have an eRA Commons account.

Exclusions

This funding opportunity does NOT support projects that meet the NIH Definition of a Clinical Trial. Applications proposing clinical trials will be considered non-responsive and will not be reviewed.
The grant will NOT support the initial Discovery Phase of biomarkers (i.e., identifying new biomarkers, developing detection technology, or initial preliminary validation studies). Only validation of strong candidate biomarkers with robust preliminary data is eligible.
Cost sharing is NOT required for this funding opportunity.

Application Process

Applying for this grant requires careful attention to deadlines, specific documentation, and adherence to federal submission platforms. Application Deadlines and Timeline

Letter of Intent Due Date: Although not required or binding, it's highly encouraged to submit a Letter of Intent 30 days prior to the application due date.
Application Due Dates: Applications are accepted on specific dates throughout the year. The latest final due date for applications is May 07, 2026, by 5:00 PM local time of the applicant organization.
- Note: If a submission date falls on a weekend or federal holiday, the deadline is automatically extended to the next business day.
Project Duration: You can request a project period of up to five years.
Review and Award Cycles: For applications submitted by the May 07, 2026 deadline, the Scientific Merit Review is anticipated in July 2026, the Advisory Council Review in October 2026, with the earliest project start date in December 2026.

Application Procedure and Submission

Electronic Submission is MANDATORY: Paper applications will not be accepted.
You must access the application forms package through one of these platforms:
- NIH ASSIST system: For online preparation, submission, and tracking.
- Institutional System-to-System (S2S) solution: Check with your organization's officials.
- Grants.gov Workspace: For preparing and submitting your application.
Timely Submission: It is strongly recommended to submit applications early to allow time to correct any errors found during the submission process. Applications that miss the deadline will be considered late.
Tracking: After submitting through Grants.gov, you must track the status of your application in the eRA Commons.

Required Documentation and Materials Applicants must follow the instructions in the NIH 'How to Apply - Application Guide' and any specific instructions provided in this funding opportunity. Key requirements include: * Standard forms like SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile. * A detailed budget with justifications for the entire study and data analysis period. * PHS 398 Research Plan, including comprehensive sections on: * Significance: Explain the scientific and biological relevance, the questions addressed, and potential impact. * Approach: Describe study objectives, design, population, statistical analysis plan, and how potential biases will be minimized. For biomarker studies, detail performance evaluation plans. * Quality Management Plan: Describe standard processes, staff training, and monitoring for clinical study procedures and data quality. * Clinical Data Management Plan: Detail validated systems for data verification, validation, confidentiality, and privacy. * Schedule of Events: If your study involves prospective data collection, provide a schematic or text describing the protocol's schedule for individual participants. * Resource Sharing Plan: Outline how you will share research resources. * Data Management and Sharing Plan: Mandatory for all research generating scientific data, regardless of direct costs. This is separate from the Clinical Data Management Plan. * PHS Human Subjects and Clinical Trials Information: Required if human subjects are involved, detailing recruitment, retention, and the overall study team structure. * Letters of Support: Encouraged from clinical partners, research collaborators, or other relevant groups. * Appendix: Limited to blank questionnaires or surveys; no publications or other materials. Application Assistance

eRA Service Desk: For system-related questions (ASSIST, eRA Commons, errors).
NIH Grants Information: For general application instructions and resources.
Grants.gov Customer Support: For registration and Workspace issues.
Scientific/Research Contact(s): Strongly encouraged to consult with NIDCR Scientific/Research staff before applying to discuss suitability of your concept for this NOFO, especially if your direct costs are $500,000 or more annually.

Evaluation Criteria

Applications are rigorously evaluated for their scientific and technical merit by NIDCR scientific review groups. The primary goal of the review is to assess the potential for the project to have a lasting and significant impact on the research field. Scored Review Criteria Reviewers will assign scores based on the following three key factors: * Importance of the Research (Significance and Innovation): How crucial and groundbreaking is the proposed study? Does it address a significant question or need in dental, oral, or craniofacial health? For biomarker studies, is there clear evidence supporting the candidate biomarker's utility and are its initial validation results robust? * Rigor and Feasibility (Approach): How well-designed and executable is the proposed research? Is the study design appropriate for answering the research question? Is the methodology sound, including sample size, data analysis, and plans for handling biases? For multi-site studies, is there a feasible plan for recruiting participants? Does the application include a Quality Management Plan, Clinical Data Management Plan, and Schedule of Events (if applicable) that demonstrate robust data integrity and quality control? * Expertise and Resources (Investigator(s) and Environment): Do the research team members (investigators) possess the necessary skills, knowledge, and experience to carry out the project successfully? Does the research environment (institution, facilities, collaborators) provide adequate support and resources for the proposed work? Additional Review Criteria (Not Scored, but Considered) Reviewers will also consider these aspects, which contribute to the overall impact score but are not separately graded: * Protections for Human Subjects: Adequacy of plans to protect the safety, rights, and welfare of human participants. * Vertebrate Animals: If applicable, the ethical treatment and justification for using vertebrate animals. * Biohazards: Assessment of potential hazards and proposed protective measures. * Resubmissions/Renewals: For resubmitted applications, evaluation of how previous critiques were addressed. For renewals, assessment of progress made during the prior funding period. * Other Attachments: Evaluation of the submitted Quality Management Plan, Clinical Data Management Plan, and Schedule of Events (if prospective data collection is proposed) to ensure they are adequate and appropriate. Additional Review Considerations (Not Scored, but Considered)

Authentication of Key Biological and/or Chemical Resources: Plans for ensuring the validity of critical resources.
Budget and Period of Support: Whether the requested budget and project duration are justified and reasonable for the proposed research.

Funding Decision Factors Final funding decisions will be based on: * The scientific and technical merit as determined by peer review scores. * The availability of funds. * The relevance of the proposed project to NIDCR's program priorities.

Compliance & Special Requirements

Award recipients are subject to a range of federal regulations, policies, and specific terms related to this cooperative agreement, ensuring ethical conduct, data security, and proper project management. Regulatory Compliance

Federal Regulations: Compliance with 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
NIH Grants Policy Statement: Adherence to all policies outlined in this comprehensive document.
Nondiscrimination Laws: Recipients must comply with all applicable nondiscrimination laws, as agreed upon during SAM.gov registration, and submit an Assurance of Compliance (HHS-690).
Federal Statutes and Regulations: Compliance with all federal statutes and regulations relevant to federal financial assistance.
Termination Clauses: NIH reserves the right to terminate awards under certain circumstances, such as non-compliance, failure to implement the protocol, recruitment shortfalls, or significant protocol changes without NIDCR concurrence.

Data and Information Management

Data Management and Sharing (DMS) Policy: Consistent with the 2023 NIH Policy, recipients must adhere to and implement an approved Data Management and Sharing Plan for all generated scientific data.
Public Data Availability: Recipients are required to make all study materials, procedure manuals, and final datasets available in the public domain, and publish/disseminate results publicly.
Health IT Compliance: If the award involves implementing, acquiring, or upgrading health IT, it must meet standards in 45 CFR part 170, Subpart B, and be certified under the ONC Health IT Certification Program if applicable to clinicians in ambulatory settings or hospitals.
Cybersecurity: Organizations with ongoing access to HHS systems or handling Personally Identifiable Information (PII) or Personal Health Information (PHI) from the HHS must develop cybersecurity plans and procedures modeled after the NIST Cybersecurity framework.

Ethical and Human Subjects Requirements

Human Subjects Protection: Recipient institutions must obtain Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval for their protocols.
NIDCR Clinical Terms of Award: Adherence to these terms, which require study monitoring commensurate with potential risk to participants and study complexity.
Inclusion Policies: Compliance with NIH policy requirements for the inclusion of women, minorities, and children in research.

Cooperative Agreement Specifics

Substantial NIH Involvement: Unlike typical grants, a Cooperative Agreement involves substantial scientific or programmatic participation from NIH staff (e.g., NIDCR Project Scientist, Program Official, Medical Officer). They provide scientific/programmatic support, monitor progress, advise on management, and review compliance.
Recipient's Primary Responsibility: Despite NIH's involvement, the recipient retains the dominant role and primary responsibility for the project's overall scientific leadership, data custody, quality control, and adherence to human subject protections.
Third-Party Involvement: Any involvement of industry or other third parties (excluding patent/copyright licensing) requires notification and concurrence from NIDCR.
Dispute Resolution: A specific procedure involving a three-member panel is available for scientific or programmatic disagreements between recipients and NIH.

Mandatory Disclosures

Recipients must report any information related to violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award.

Grant Details