NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required) | PAR 25 343

Opportunity Information: Apply for PAR 25 343

The NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required), funding opportunity number PAR-25-343 (CFDA 93.173), is a discretionary NIH grant mechanism designed to move communication-disorder interventions forward through rigorous clinical trials. The core purpose is to identify effective treatments or preventive approaches for disorders of hearing, balance, smell, taste, voice, speech, and language by supporting trials that are well designed, carefully executed, and capable of producing results that can meaningfully inform clinical practice and future research.

This FOA specifically targets clinical trials that fall into at least one of three higher-stakes categories: trials that require FDA oversight, trials intended to formally establish efficacy (rather than exploratory or feasibility-focused studies), or trials that carry a higher risk of physical or psychological harm to participants. In other words, it is meant for more definitive, tightly governed studies where regulatory compliance, participant protections, and strong trial infrastructure are essential. The "U01" cooperative agreement structure also signals that NIDCD expects substantial scientific involvement from the agency, with an NIDCD Project Scientist working collaboratively with the awardee. That arrangement typically means more active coordination and shared responsibility than a standard investigator-initiated research project grant, which can be especially important for complex trials that need close alignment on protocol oversight, safety monitoring, operational milestones, and data quality.

A wide range of applicant organizations are eligible. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those specific nonprofit categories); for-profit organizations other than small businesses; small businesses; and other entities that meet NIH eligibility rules. The announcement also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, Indian/Native American Tribal Governments other than federally recognized, and U.S. territories or possessions. At the same time, it clearly excludes non-domestic (non-U.S.) entities from applying, and it also excludes non-domestic components of U.S. organizations, meaning the applicant organization and the funded components of the work must be based domestically under the terms stated.

Administrative details provided in the source data indicate the sponsoring agency is the National Institutes of Health, the instrument is a cooperative agreement, and the activity category is health. The posting lists an original closing date of 2027-10-18 and a creation date of 2025-01-06. An award ceiling is not specified in the provided text, and the expected number of awards is not listed, which generally means applicants should consult the full FOA and NIH guidance to understand budget expectations, allowable costs, and any institute-specific limits or recommended ranges. Overall, this opportunity is geared toward teams ready to run a more definitive or higher-risk clinical trial in communication disorders with strong governance, compliance planning, and the capacity to partner closely with NIDCD scientific staff throughout the life of the study.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173.
• This funding opportunity was created on 2025-01-06.
• Applicants must submit their applications by 2027-10-18.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 25 343

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