NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required) | PAR 21 064

Opportunity Information: Apply for PAR 21 064

The NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required), funding opportunity number PAR-21-064, is a National Institutes of Health (NIH) grant program designed to support rigorous clinical trials focused on the treatment or prevention of communication disorders. The central purpose of the opportunity is to move promising interventions toward clear evidence of benefit by funding trials that are well designed, carefully executed, and closely monitored. Because these studies can be complex, expensive, or higher risk, the program uses a cooperative agreement mechanism (U01), meaning the funded research is conducted with substantial scientific involvement from NIDCD, including an NIDCD Project Scientist who works alongside the investigative team. This structure is intended to strengthen trial planning and execution through ongoing interaction, oversight, and guidance rather than a more hands-off relationship typical of many standard research grants.

This FOA is specifically aimed at clinical trials that meet at least one of several triggering criteria indicating greater need for oversight. Trials are appropriate for this mechanism if they require FDA oversight, have annual direct costs at or above $500,000, are intended to formally establish efficacy (as opposed to early-stage exploratory testing), or carry a higher risk of potentially causing physical or psychological harm. The announcement also notes that applications with annual direct costs of $700,000 or more may fit within the scope of this FOA as well, reinforcing that the program is structured for larger, more demanding studies. A key limitation is that only one clinical trial may be proposed per U01 application under this opportunity, so the application is expected to be focused on a single, clearly defined trial with a full operational plan.

Eligibility is broad across many U.S.-based organizational types, reflecting the NIH goal of enabling diverse institutions and communities to lead clinical research. Eligible applicants include state, county, city, township, and 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 tribal governments; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education where specified); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights 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), faith-based or community-based organizations, regional organizations, eligible federal government agencies, and U.S. territories or possessions.

At the same time, the opportunity draws clear boundaries around foreign participation. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed when they meet the NIH definition in the NIH Grants Policy Statement, meaning a U.S. applicant may include certain well-justified foreign elements of the research (for example, specific collaborations or activities) as part of the overall project, provided the main applicant organization remains eligible and U.S.-based.

Administratively, the opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument. It falls under the health funding activity category and is associated with CFDA number 93.173. The source information lists an original closing date of 2023-10-10 and a creation date of 2020-12-11; applicants would typically confirm the current status, active submission dates, and any reissued versions of the FOA on NIH/Grants.gov because NIH opportunities are sometimes updated, extended, or replaced over time. Overall, this program is best suited for investigators proposing a single, later-stage or higher-stakes communication-disorders clinical trial where the added partnership with NIDCD staff can improve trial quality, participant safety, regulatory compliance, and the likelihood of producing a definitive answer about efficacy or prevention.

• 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 2020-12-11.
• Applicants must submit their applications by 2023-10-10. (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.

Apply for PAR 21 064

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: