NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required) | PAR 24 050

Opportunity Information: Apply for PAR 24 050

The NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required), funding opportunity number PAR-24-050, is an NIH discretionary grant mechanism designed to support rigorous clinical trials aimed at improving the treatment or prevention of communication disorders. The core purpose of the opportunity is to move beyond early-stage or exploratory work and fund well designed, well executed trials that can meaningfully inform clinical practice and patient outcomes in areas tied to hearing, balance, taste, smell, voice, speech, and language. This FOA is specifically structured to help generate strong clinical evidence for interventions intended to address communication-related conditions, reflecting NIDCDs emphasis on interventions that are ready for formal testing in humans under tightly controlled and carefully monitored conditions.

A defining feature of this FOA is that it uses the cooperative agreement (U01) mechanism, which signals substantial scientific or programmatic involvement by NIDCD during the life of the award. In practical terms, the project is carried out as a collaboration between the funded investigative team and an NIDCD Project Scientist. While the investigators remain responsible for leading the study and executing the protocol, the cooperative structure typically means more active engagement from the institute than under a standard research project grant, especially around scientific coordination, milestone tracking, and ensuring the trial is conducted to the level of rigor expected for higher-stakes clinical research.

This announcement is targeted to clinical trials that meet any of three key conditions. First, it supports trials that require FDA oversight, which generally includes studies involving regulated drugs, biologics, or devices, or studies conducted under an IND or IDE framework as applicable. Second, it supports trials intended to formally establish efficacy, meaning the study is designed to provide definitive evidence that an intervention works, often with robust endpoints, appropriate control conditions, and a statistical plan that can support clear efficacy conclusions. Third, it supports trials considered higher risk, where participation could potentially lead to physical or psychological harm. That higher-risk focus implies an expectation of strong human subjects protections, safety monitoring, careful adverse event reporting, and oversight commensurate with the risk profile of the intervention and participant population.

Eligibility is broad and includes many common domestic applicant types: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (as long as they are not institutions of higher education when applying under those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other organizations that meet NIH eligibility rules for this program. The FOA also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, and faith-based or community-based organizations, as well as regional organizations and U.S. territories or possessions. These inclusions underscore NIHs interest in supporting a wide range of institutions, including those serving underrepresented or historically marginalized communities, and can be especially relevant for trials that require broad recruitment or that aim to address disparities in communication health outcomes.

At the same time, the FOA draws a firm line on foreign eligibility. Non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement. In effect, the applicant organization must be U.S.-based and meet NIH rules, but the project can include certain international elements if they qualify as foreign components under NIH policy and are properly justified in the application.

From an administrative standpoint, this is an NIH health-related funding opportunity under CFDA number 93.173, with the agency listed as the National Institutes of Health. The opportunity was created on 2023-10-20, and the listed original closing date is 2026-10-27. The FOA excerpt provided does not specify an award ceiling or the expected number of awards, which typically means applicants should consult the full FOA text for budget guidance, any institute-specific caps, and details on the anticipated funding level and award count for particular receipt dates.

Overall, PAR-24-050 is best read as a pathway for teams who are ready to run a consequential, closely overseen clinical trial in communication disorders, particularly when the study crosses into FDA-regulated territory, is designed to deliver definitive efficacy conclusions, or poses higher risk that demands enhanced oversight and careful trial governance. The cooperative agreement structure is central: applicants should be prepared not only to run a high-quality clinical trial, but also to work in an active partnership with NIDCD staff to meet scientific and operational expectations throughout the project period.

• 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 2023-10-20.
• Applicants must submit their applications by 2026-10-27. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

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