NIDCD Research Grants for Translating Basic Research into Clinical Practice (R01 Clinical Trial Optional)

The National Institute on Deafness and Other Communication Disorders (NIDCD) has issued a Notice of Funding Opportunity (NOFO) titled NIDCD Research Grants for Translating Basic Research into Clinical Practice (R01 Clinical Trial Optional), reissued as RFA-DC-25-002. The goal of this opportunity is to support milestone-driven research projects that translate peer-reviewed and published basic research findings into clinical applications that address the diagnosis, treatment, and prevention of disorders related to hearing, balance, voice, speech, language, taste, and smell. The outcomes of the proposed work must have a clear connection to clinical conditions and demonstrate a strong potential for immediate practical clinical impact. This NOFO emphasizes collaborative **translational research** involving both **basic scientists and clinicians or clinician-scientists**. Proposals are encouraged to address existing challenges in clinical care and to include engagement with **end users** (e.g., patients, practicing clinicians) to ensure applicability in real-world environments. Eligible activities include developing new diagnostic tools, medical procedures, therapeutic interventions, behavioral therapies, and assistive devices. Preclinical studies in non-human models will only be considered with prior approval from NIDCD, provided a subsequent clinical trial is anticipated in the near term. The NOFO requires that applicants present projects using a **milestone-based structure** instead of a traditional hypothesis-driven format. Applicants must delineate project phases, clearly define criteria for milestone completion, and include **contingency plans** to address potential obstacles. A **Milestone Plan** attachment is mandatory for submission, and projects lacking this plan will be withdrawn without review. Proposed clinical trials that are low-risk and align with NIDCD’s mission are appropriate; however, higher-risk clinical trials must be submitted under an alternate mechanism (U01). Projects focused on mechanistic discovery research, proof-of-concept studies, or those addressing basic science questions are not eligible. Eligible applicants include higher education institutions, nonprofits, for-profit organizations (including small businesses), local and state governments, tribal entities, and foreign organizations. Multi-disciplinary, multi-institutional collaborations and partnerships with industry are encouraged, particularly when commercialization is a long-term goal. Applications requesting **$500,000 or more** in direct costs for any single year require prior NIDCD approval at least **6 weeks before submission**. The maximum project period is **5 years**, with annual direct costs not exceeding **$500,000**, unless otherwise pre-approved. Applications are due by **February 13, 2025**, with additional deadlines on **October 13, 2025**, and **June 12, 2026**. Applicants are encouraged to submit early to address any technical errors during the submission process. Scientific merit review will take place in **July 2025**, with advisory council review in **October 2025** and funding decisions expected by **December 2025**. The program anticipates funding **2-3 awards** with an estimated total budget of **$2 million** in fiscal year 2025. Peer reviewers will assess applications based on **significance, innovation, approach, and feasibility**, as well as the expertise of investigators and the project environment. Strong proposals will demonstrate a clear translational pathway, well-defined milestones, and an impactful connection between basic findings and clinical applications. Additionally, recruitment plans for human subjects must prioritize engagement of underrepresented populations in biomedical research, including racial and ethnic minorities. For questions about project alignment, clinical trial eligibility, or milestone requirements, applicants are encouraged to contact the NIDCD **Scientific/Research Contact** at least 6 weeks prior to submission. This NOFO reflects NIDCD’s commitment to advancing translational research that improves clinical care and quality of life for individuals with communication disorders.