Grants8 | The most comprehensive grants search on the web

Grant Analysis

Purpose & Target

• Core objective: To support the planning (UG3 phase) and implementation (UH3 phase) of well-designed, rigorously conducted behavioral and biopsychosocial intervention clinical trials. • These studies must be relevant to dental, oral, and craniofacial (DOC) health, as well as associated medical and mental health conditions or comorbidities. • Target recipient type and size: This grant targets a broad range of organizations including higher education institutions, various types of non-profits, for-profit organizations (including small businesses), and various local government and community-based entities. No specific size limits are mentioned for recipient organizations. • SECTOR-SPECIFIC: This grant is SECTOR-SPECIFIC focusing on clinical research in dental, oral, and craniofacial health. • Geographic scope: Open to domestic (U.S.) organizations only. Foreign organizations are not eligible to apply directly, but foreign components can be part of a U.S. organization's application. • Key filtering criteria: Applicants must propose an NIH-defined clinical trial focusing on behavioral/biopsychosocial interventions related to DOC health. The grant specifically excludes projects involving the testing of drugs, devices, or biologics regulated by the FDA. • Grant frequency and program context: This funding opportunity (PAR-25-188) is a reissue of a previous announcement (PAR-21-317), indicating it is a recurring program.

Financial Structure

Funding Instrument: This is a Cooperative Agreement (UG3/UH3 biphasic).
Budget Range: Application budgets are not limited but must reflect the actual needs of the proposed project.
Annual Direct Costs: If direct costs are $500,000 or more in any single year (excluding consortium F&A), applicants are required to follow NIDCR policy and contact a Scientific/Research Contact at least 8 weeks prior to submission.
Cost Sharing: Not required.
Project Period: The UG3 (planning) phase may provide support for 1 year. The UH3 (implementation) phase may provide up to 5 years of support.
Financial Reporting: Recipients must submit annual Research Performance Progress Reports (RPPR) and financial statements as required by the NIH Grants Policy Statement. A final RPPR, invention statement, and expenditure data are required for award closeout.

Eligibility Requirements

Organization Type

Eligible:
- Higher Education Institutions (Public/State Controlled, Private)
- Nonprofits (501(c)(3) IRS Status, Non-501(c)(3))
- For-Profit Organizations (Small Businesses, Other For-Profit)
- Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal (Federally Recognized and Other))
- 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

Geographic Location

Must be a domestic (U.S.) entity.
Non-domestic (non-U.S.) Entities are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed within a U.S. organization's application.

Project Type

Must propose at least one NIH-defined clinical trial in the UH3 (implementation) phase.
Must focus on behavioral/biopsychosocial intervention studies.
Exclusion: Projects testing drugs, devices, or biologics regulated by the FDA are not supported by this NOFO.

Registration & Compliance

Applicant organizations must complete and maintain active registrations in:
- System for Award Management (SAM) - requires annual renewal.
- Unique Entity Identifier (UEI) - issued via SAM.gov.
- eRA Commons - for organization and all Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)).
- Grants.gov - requires active SAM registration.
All registrations must be completed prior to the application submission date.

Application Specifics

Must submit a single UG3/UH3 application.
The application must include overall goals and hypotheses for the entire project, as well as specific aims and research plans for both the UG3 and UH3 phases.
A Study Timeline and Milestones Plan, covering both UG3 and UH3 time-periods and including annual milestones, is required.
The application must discuss a hypothesized mechanism of causal change, or provide a compelling argument why one is not applicable.
If requesting $500,000 or more in direct costs in any year, applicants must contact a Scientific/Research Contact at least 8 weeks before submitting the application.
Applicant organizations may submit more than one application, provided each is scientifically distinct; duplicate or highly overlapping applications will not be accepted.

Application Process

Application Timeline

Latest Application Due Date: 2027-10-08 17:00:00 (5:00 PM local time of applicant organization). If this date falls on a weekend or federal holiday, the deadline is automatically extended to the next business day.
Earliest Submission Date: January 07, 2025.
Expiration Date: January 07, 2028 (no new applications accepted after this date).
Letter of Intent Due Date: 30 days prior to the application date (recommended but not required or binding).

Project Period

UG3 (Planning Phase): 1 year.
UH3 (Implementation Phase): Up to 5 years.
Total Maximum Project Period: 6 years.

Submission Process

Applications must be submitted electronically through Grants.gov.
Submission options include NIH ASSIST system, institutional system-to-system (S2S) solutions, or Grants.gov Workspace.
Applicants must track their application status in eRA Commons.
Early submission is encouraged to allow for correction of any errors found during the submission process.
Applications that are incomplete, non-compliant, or non-responsive (e.g., missing a Study Timeline and Milestone Plan) will not be reviewed.

Required Documentation and Materials

Standard SF424(R&R) application forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, Budget, Subaward Budget).
PHS 398 Cover Page Supplement.
PHS 398 Research Plan: Must be meticulously clear and organized, detailing overall goals, hypotheses, and specific aims for both the UG3 and UH3 phases. It should include separate sections for activities proposed in each phase.
Study Timeline and Milestone Plan: A required attachment including a schedule of events for the UH3 phase and clear annual UG3 and UH3 milestones. Milestones must be objective, measurable, and achievable.
Study Accrual and Retention Plan: Required attachment addressing feasibility of participant recruitment, a timeline with accrual goals, retention strategies, and contingency plans.
Data and Safety Monitoring Plan: Required, describing the plan to ensure adherence to protocol, adequate consent documentation, intervention fidelity, data integrity, and adverse event reporting.
Statistical Design and Power: Required for human subjects research.
Resource Sharing Plan.
Data Management and Sharing Plan (required for all research generating scientific data).
Appendix: Limited to blank questionnaires or blank surveys; no publications or other material allowed.
PHS Human Subjects and Clinical Trials Information form: Required when human subjects research, clinical research, or NIH-defined clinical trials are involved.

Pre-application Guidance

Applicants are strongly encouraged to consult with NIDCR staff early in the planning process to discuss project scope and intent.
Mandatory contact with a Scientific/Research Contact at least 8 weeks prior to submission is required for applications requesting $500,000 or more in direct costs in any year.

Evaluation Criteria

Overall Impact Score

Reviewers will provide 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): Assesses the project's potential to improve scientific knowledge and its innovative aspects.
Factor 2: Rigor and Feasibility (Approach): Evaluates the scientific rigor of the proposed research design and the feasibility of the chosen approach.
Factor 3: Expertise and Resources (Investigator(s) and Environment): Assesses the qualifications, experience, and leadership of the research team, and the adequacy of the institutional environment and resources.

Additional Review Criteria (not separately scored, but contribute to overall impact)

Protections for Human Subjects: Evaluation of the plan to protect human participants in the study.
Vertebrate Animals: If applicable, evaluation of the plans for the care and use of vertebrate animals.
Biohazards: If applicable, assessment of potential biohazards and safety measures.

Additional Review Considerations (not scored, but contribute to overall impact)

Authentication of Key Biological and/or Chemical Resources: Assessment of plans for identifying and ensuring the validity of key biological and/or chemical resources.
Budget and Period of Support: Evaluation of whether the proposed budget and requested project period are fully justified and reasonable in relation to the proposed research.

Funding Decisions

Decisions on funding will consider:
- Scientific and technical merit of the proposed project, as determined by peer review.
- Availability of funds.
- Relevance of the proposed project to NIDCR program priorities.

Compliance & Special Requirements

Regulatory Compliance

Adherence to all applicable NIH Grants Policy Statement terms and conditions, federal regulations (2 CFR Part 200, Uniform Administrative Requirements), and HHS grant administration regulations.
Compliance with all applicable nondiscrimination laws is required, affirmed through SAM.gov registration and submission of Assurance of Compliance (HHS-690).
Compliance with all federal statutes and regulations relevant to federal financial assistance.
Clinical research projects involving investigational therapeutics, vaccines, or medical interventions must comply with FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements.

Data Management and Sharing

Compliance with the 2023 NIH Policy for Data Management and Sharing is required for all applications generating scientific data.
A Data Management and Sharing Plan must be submitted and implemented as described.
Awardees retain primary rights to data, but the Government has rights of access consistent with HHS, PHS, and NIH policies.

Ethical Standards and Human Subjects

Strict adherence to protections for human subjects is required.
All research protocols must be reviewed and approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Data and Safety Monitoring requirements apply to all NIH-supported human biomedical and behavioral intervention studies to ensure participant safety and data integrity.
Accrual goals should address the NIH Policy on Inclusion of Women and Minorities as Subjects in Clinical Research.

Technical and Operational Requirements

If the award funds health IT activities, the health IT must meet standards and implementation specifications adopted in 45 CFR part 170, Subpart B.
If funding targets health IT for eligible clinicians in ambulatory settings or hospitals, it must use ONC Health IT Certified Technology.
Recipients with access to HHS IT systems and Personal Identifiable Information (PII) or Personal Health Information (PHI) must develop cybersecurity plans based on the NIST Cybersecurity Framework.

Cooperative Agreement Specifics

This is a Cooperative Agreement, implying substantial Federal scientific or programmatic involvement from NIH staff (NIDCR).
While NIH staff are involved, the recipient retains the dominant role and prime responsibility for the project.
NIDCR staff (Project Scientist, Program Official, Medical/Dental Officer) will consult, advise, monitor progress, and review activities.
NIDCR may convene a Data and Safety Monitoring Board (DSMB) to review study data and progress.
NIDCR reserves the right to terminate or curtail a study if milestones are not met, participant recruitment/retention falls short, protocol breaches occur, or substantive changes are made without NIDCR concurrence.
Awardees are required to make all study materials, procedure manuals, and final datasets available in the public domain.
Public dissemination of results, data, and other products is expected, with appropriate acknowledgment of NIH/NIDCR support.
Involvement of industry or any other third party (except for licensing patents/copyrights) requires prior notification and concurrence by NIDCR.

Special Project Scope Considerations

The UG3 planning phase prohibits a full pilot of the UH3 planned intervention.
Applications will be considered non-responsive if they involve the testing of drugs, devices, or biologics regulated by the FDA.
Applications employing novel or advanced features (e.g., mobile health, artificial intelligence, telehealth, responsive health system records, Sequential Multiple Assignment Randomized Trial (SMART) designs) are encouraged.

Grant Details