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Grant Analysis

Purpose & Target

Grant Purpose and Target

Clear core objective: To translate peer-reviewed and published basic research findings into practical clinical applications for better human health, specifically addressing disorders of hearing, balance, smell, taste, voice, speech, and language.
Explicit identification of target recipient type and size: The grant targets a wide range of organizations, including higher education institutions, nonprofits, for-profit organizations (including small businesses), and various government entities.
MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': SECTOR-SPECIFIC (Healthcare/Biomedical Research, specifically communication disorders).
Geographic scope and any location requirements: Open to domestic (U.S.) and international (non-U.S.) entities. Foreign components of U.S. organizations are also eligible.
Key filtering criteria for initial grant screening:
Focus on translational research within NIDCD's mission areas.
Must be based on published basic research findings.
Project must have clear, near-term clinical impact.
Projects should be milestone-driven.
Excludes high-risk clinical trials, basic discovery research, and projects solely on underlying disease mechanisms.
Grant frequency and program context: This is a recurring grant, reissued from previous announcements (e.g., RFA-DC-22-001), indicating a continued program priority of the NIDCD within the NIH.

Financial Structure

Grant type: Financial assistance (Grant).
Total anticipated funding for FY25: $2,000,000.0.
Maximum funding per grant: Less than $500,000.0 direct costs per year. Applicants requesting $500,000.0 or more in direct costs in any year must contact a Scientific/Research Contact at least 6 weeks before submitting.
Project period: Maximum 5 years.
Currency: USD.
Cost sharing: Not required.
Funding rate: 100.0% of eligible costs.
Pre-award costs: Allowable only as described in the NIH Grants Policy Statement Section 7.9.1.
Financial reporting: Recipients must submit Research Performance Progress Reports (RPPR) annually and financial statements as required. Reporting to the Federal Subaward Reporting System (FSRS) is required for subawards over $25,000.0.
Recipient integrity: For recipients with active federal grants cumulatively valued greater than $10,000,000.0, information regarding civil, criminal, and administrative proceedings must be reported and maintained in SAM.
Closeout: A final RPPR, invention statement, and expenditure data are required for award closeout.

Eligibility Requirements

Organization Type

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

Geographic Location

Organizations from the United States (including territories and possessions) are eligible.
Non-domestic (non-U.S.) entities (Foreign Organizations) are eligible to apply.
Foreign components of U.S. organizations are allowed.

Technical Expertise & Team

Strongly encouraged to have joint Program Director/Principal Investigators (PD/PIs) with expertise in basic science AND clinical science.
Additional relevant expertise is encouraged, including biostatistics, bioinformatics, bioengineering, health economics, epidemiology, imaging, pharmacology, pharmacogenetics, psychology, and regulatory expertise.

Research Scope & History

Projects must translate peer-reviewed and published basic research findings into clinical applications within NIDCD's scientific mission areas (hearing, balance, smell, taste, voice, speech, and language disorders).
A clear connection to a clinical condition must be established, demonstrating potential for practical clinical impact in the near term.
Projects may include human subjects. Preclinical studies in non-human models are allowed only with prior NIDCD approval and if a subsequent clinical trial is anticipated in the near term.
Investigator-initiated low-risk clinical trials are responsive to this NOFO.
Projects are NOT intended for: outcomes/health services research, extension of ongoing clinical studies, optimization of existing clinical protocols (in the absence of new basic discovery), early-stage translational studies seeking proof of concept data, or high-risk clinical trials.
Basic discovery research or projects solely addressing underlying disease mechanisms are NOT responsive.
Renewals or extensions of work previously funded under RFA-DC-22-001, PAR-18-533, PAR-17-184, or PAR-14-009 will not be accepted.
Total support from this NOFO and previous related initiatives cannot exceed 5 years.

Required Registrations

Applicant organizations must complete and maintain active registrations with:
System for Award Management (SAM)
NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations)
Unique Entity Identifier (UEI)
eRA Commons (for organization and all PD/PIs)
Grants.gov

Application Process

Application Process Overview

Applications must be submitted electronically through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Applicants are strongly encouraged to submit applications early to allow adequate time for corrections.
No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Key Dates

Letter of Intent Due Date: 30 days prior to the application due date (encouraged, not required).
Application Due Dates (by 5:00 PM local time of applicant organization):
February 13, 2025
October 13, 2025
June 12, 2026
February 12, 2027
October 12, 2027
Earliest Start Dates: December 2025, July 2026, April 2027, December 2027, July 2028.
Expiration Date of NOFO: October 13, 2027.

Required Documentation and Materials

Standard NIH application forms (SF424(R&R) series, PHS 398 series).
Approval to Submit Letter: Required for projects proposing studies using non-human models. This one-page PDF letter, named 'ApprovalToSubmit.pdf', must be obtained from the NIDCD Research/Scientific Contact at least 6 weeks prior to submission and included as an 'Other attachment'.
Milestone Plan: A one-page PDF plan, named 'MilestonePlan.pdf', detailing project work stages, criteria for completion of each stage, and a timeline. This is distinct from contingency plans, which should be included in the Research Strategy.
Data Management and Sharing Plan: Required for all applications that generate scientific data, regardless of the amount of direct costs requested.
Resource Sharing Plan: Applicants are required to comply with instructions for resource sharing.
For clinical trials: Complete the PHS Human Subjects and Clinical Trials Information form, including a detailed recruitment and retention plan for human subjects.

Application Content Instructions

Specific Aims: Must clearly summarize what is being translated and how the outcomes can influence clinical practice.
Research Strategy: Must describe the translational nature and scope of the project, including the connection to a clinical condition and potential for translation of basic research findings into new clinical tools. A milestone-based structure is required.
Multiple PD/PI Leadership Plan (if applicable): Must describe the organizational structure, procedures for maintaining partnership, and plans for data sharing, recognition, and intellectual property rights.

Pre-Application Support and Contacts

Letter of Intent: Should be sent to Melissa Stick, Ph.D., MPH (NIDCD).
Scientific/Research Contact (Kelly King, Au.D., Ph.D., NIDCD): Should be contacted at least 6 weeks in advance if proposing studies with non-human models or requesting $500,000 or more in direct costs in any year.

Post-Submission

Post-submission materials: Follow NIH policy guidelines.
Notification: Applicants are requested to notify the NIDCD Referral Office by email after application submission, including the NOFO number/title, PD/PI name, and application title.

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood of the project exerting a sustained, powerful influence on the relevant research field(s).

Scored Review Criteria

Importance of the Research (Significance and Innovation): This evaluates the potential impact and novelty of the proposed translational research within NIDCD's mission areas.
Rigor and Feasibility (Approach): This assesses the soundness, rigor, and feasibility of the scientific approach. It also considers how well the milestone plan delineates project stages, completion criteria, and contingency plans.
Expertise and Resources (Investigator(s) and Environment): This evaluates whether the Program Director(s)/Principal Investigator(s) and the research team possess the necessary skills and experience, and if the research environment is suitable for the proposed work.

Additional Review Criteria (considered for overall impact score, but not scored individually)

Protections for Human Subjects: Evaluation of plans for human subject safety and ethical considerations.
Vertebrate Animals: Evaluation of plans for animal welfare and ethical use (if applicable).
Biohazards: Assessment of plans for managing potential biohazards.
Resubmissions: Evaluation of improvements and revisions from previous application submissions.
Revisions: Appropriateness of any proposed expansion of the project's scope.
Human Subjects Recruitment Plan: Assessment of innovative and proactive strategies for recruiting underserved, understudied, or minority health/health disparity populations.

Additional Review Considerations (not scored, not directly for overall impact score, but checked)

Authentication of Key Biological and/or Chemical Resources: Brief plans for identifying and ensuring the validity of these resources are evaluated.
Budget and Period of Support: The justification and reasonableness of the requested budget and project period are assessed.
For Clinical Trials: Low-risk clinical trials, even if not innovative in design, are considered acceptable if they address important questions or unmet needs.

Compliance & Special Requirements

Regulatory Compliance & Standards

Adherence to NIH Grants Policy Statement and 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
Compliance with all applicable non-discrimination laws, including submission of HHS-690 Assurance of Compliance.
Compliance with all federal statutes and regulations relevant to federal financial assistance, as highlighted in NIH Grants Policy Statement Section 4.
For clinical trials, adherence to ClinicalTrials.gov registration and results reporting requirements.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for all human subjects protocols.
Data and Safety Monitoring is required for all NIH-supported human biomedical and behavioral intervention studies.
Compliance with Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements for projects involving investigational therapeutics or devices.

Data & IT Compliance

Compliance with the 2023 NIH Policy for Data Management and Sharing, including implementation of an approved Data Management and Sharing Plan.
If the award involves health IT, use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B.
For eligible clinicians in ambulatory settings or hospitals, use health IT certified under the ONC Health IT Certification Program if applicable.
If recipients/subrecipients have ongoing access to HHS systems or PII/PHI, they must develop plans and procedures modeled after the NIST Cybersecurity framework.

Risk Management & Reporting

Mandatory disclosure of any information related to violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award (2 CFR 200.113).
Reporting to the Federal Subaward Reporting System (FSRS) for all subawards over $25,000.0.
Reporting and maintaining currency of information in SAM regarding civil, criminal, and administrative proceedings for active federal grants exceeding $10,000,000.0 in cumulative value.

Project Specific Requirements & Exclusions

Projects must utilize a milestone-based structure for progress tracking, distinct from traditional hypothesis-driven R01s, and include a required one-page Milestone Plan.
Basic research referenced in the application must have been published in a peer-reviewed scientific journal.
The relevance of the research to a clinical condition must be explicitly established and clearly stated.
This NOFO does NOT support: high-risk clinical trials (these should use the U01 mechanism), basic discovery research, projects solely addressing the underlying mechanism of a disease, outcomes/health services research, extension of ongoing clinical studies, optimization of existing clinical protocols (unless based on new basic discovery), or early-stage translational studies aiming solely for proof of concept data.
Renewals of previous grants under this initiative (RFA-DC-22-001, PAR-18-533, PAR-17-184, PAR-14-009) are not accepted, and total support received from this initiative cannot exceed 5 years.

Innovation & Collaboration

Collaborative translational research between basic scientists and clinicians or clinical scientists is strongly encouraged, ideally with joint PD/PIs.
Multi-disciplinary and multi-institutional studies are encouraged as appropriate.
Academic-industrial collaborations are encouraged to support commercialization post-project completion.
Early engagement with end users (e.g., practicing clinicians, patients) in real-world environments where approaches will be employed is expected.
Proposed solutions, tools, techniques, or interventions should aim to overcome existing challenges and improve clinical care.

Grant Details