NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01-Clinical Trial Required) | PAR 18 340

Opportunity Information: Apply for PAR 18 340

The National Institute on Deafness and Other Communication Disorders (NIDCD), part of the National Institutes of Health (NIH), is offering a discretionary health funding opportunity titled "NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01-Clinical Trial Required)" under opportunity number PAR-18-340 (CFDA 93.173). The purpose of this program is to move the field toward effective treatments or preventive strategies for communication disorders by funding clinical trials that are carefully designed, well managed, and executed to high scientific and ethical standards. The emphasis is on investigator-initiated trials, meaning researchers bring forward their own intervention ideas and trial designs rather than responding to a pre-specified government-designed study.

This FOA uses the U01 mechanism, which is a cooperative agreement. In practical terms, that means the project is not run as a standard research grant where the investigator operates largely independently. Instead, it is structured for close collaboration with NIDCD, including meaningful involvement by an NIDCD Project Scientist. The cooperative agreement model is used here because the trials NIDCD expects under this announcement often benefit from added coordination, oversight, and ongoing input from the Institute, especially when the work is complex, higher cost, higher risk, or subject to additional regulatory expectations.

The announcement is specifically intended for clinical trials in communication disorders that meet at least one of several triggering conditions. A proposed study belongs in this U01 FOA if it (1) requires FDA oversight, (2) requests annual direct costs of $500,000 or more, (3) is intended to formally establish efficacy (for example, a confirmatory trial designed to definitively test whether an intervention works), or (4) poses a higher risk of potential physical or psychological harm to participants. These criteria are essentially used to separate trials that warrant enhanced NIDCD engagement from trials that are relatively lower risk and more straightforward to administer under a standard grant structure. Only one clinical trial may be proposed per application under this U01, so applicants must focus the submission on a single, clearly defined trial rather than bundling multiple trials into one package.

For clinical trials that do not meet any of the higher-oversight or higher-risk criteria above, NIDCD directs applicants to a companion opportunity that uses the R01 mechanism: "NIDCD Clinical Trials in Communication Disorders (R01-Clinical Trial Required)" (PA-18-334). That companion FOA is positioned for lower-risk trials and does not carry the same cooperative agreement structure requiring the same level of continuous Institute involvement.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, city or 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; other tribal organizations; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (outside of higher education institutions); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

At the same time, the FOA places clear restrictions on foreign participation. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply. In addition, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed. In effect, the applicant organization and the work supported under this award must remain domestic under NIH policy for this program.

From an administrative standpoint, the listing indicates the funding instrument type as a cooperative agreement and the activity category as health. The FOA record shows an original closing date of 2020-10-21, and an award ceiling is not specified in the provided source data. The opportunity record was created on 2017-11-13. Even when an older closing date is shown in a summary record, the best practice is to verify whether the FOA has been reissued, updated, or replaced and to rely on the active NIH posting and current submission dates if planning an application.

Overall, this opportunity is designed for investigators proposing more complex or higher-stakes communication-disorders clinical trials, particularly those that are large in budget, require FDA involvement, aim to definitively establish efficacy, or carry greater potential risk. The U01 structure is meant to ensure tight coordination between the research team and NIDCD so that scientific rigor, participant protections, and regulatory and operational demands are handled with the level of oversight these trials typically require.

• 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 2017-11-13.
• Applicants must submit their applications by 2020-10-21. (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 18 340

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