NIDCD Clinical Trials in Communication Disorders (R01-Clinical Trial Required) | PA 18 334

Opportunity Information: Apply for PA 18 334

The National Institute on Deafness and Other Communication Disorders (NIDCD), part of the National Institutes of Health (NIH), is seeking investigator-initiated applications for clinical trials focused on communication disorders through the R01 mechanism under the funding opportunity titled "NIDCD Clinical Trials in Communication Disorders (R01 - Clinical Trial Required)" (Funding Opportunity Number PA-18-334; CFDA 93.173). The overall purpose of this announcement is to support well-designed and well-executed clinical trials that advance the NIDCD mission by improving the diagnosis, prevention, or treatment of disorders affecting hearing, balance, smell, taste, voice, speech, and language. In practical terms, the FOA is meant to help researchers test promising interventions in human participants when the study is structured as a clinical trial and when the level of risk and regulatory complexity is relatively low.

A defining feature of this opportunity is that it is specifically intended for low-risk clinical trials. To be considered responsive, proposed trials must satisfy all of the following conditions: they must fit within the budget limits set by the FOA (with an award ceiling listed as $500,000), they must not require U.S. Food and Drug Administration (FDA) oversight, they must not be designed to formally establish efficacy in the way a pivotal or registrational trial would, and they must present low risk for causing physical or psychological harm to participants. This combination of requirements signals that NIDCD is prioritizing studies that are ethically and operationally straightforward, feasible within a standard R01 framework, and positioned to generate strong clinical evidence without the higher stakes and infrastructure demands associated with more advanced or higher-risk trials.

The FOA also provides guidance on application scope by recommending that applicants propose only one clinical trial per R01 application. That recommendation is essentially a clarity and feasibility guardrail: it encourages applicants to focus their aims, concentrate resources, and present a coherent study design rather than bundling multiple trials into a single submission. If a proposed study does not meet the "low-risk" criteria or otherwise rises to a level that is considered high risk, the announcement directs applicants to a companion funding opportunity using a cooperative agreement mechanism (U01), specifically PAR-18-340, "NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders." The presence of this companion pathway is important because it tells applicants that NIDCD has different funding lanes for different levels of trial complexity and risk, and that higher-risk trials may require closer NIH involvement and oversight typical of U01 cooperative agreements.

In terms of who can apply, eligibility is broad and includes many types of U.S. organizations and government entities. Eligible applicants listed include state, county, city, township, and special district governments; federally recognized Native American tribal governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; public housing authorities and Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3), other than institutions of higher education); for-profit organizations (other than small businesses) as well as small businesses; and other categories as permitted by NIH policy. The FOA also explicitly highlights additional eligible applicants 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 and community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, tribal governments that are not federally recognized, and non-U.S. entities (foreign organizations). This emphasis on a wide range of institution types reflects NIDCD's interest in encouraging participation from diverse research settings and communities, including those that are often underrepresented in federally funded clinical research.

Administrative details in the provided source data indicate this is a discretionary grant opportunity administered by NIH under the health funding activity category. The opportunity was created on November 13, 2017, and an original closing date is listed as December 11, 2020 (noting that NIH opportunities can have multiple receipt dates or may be reissued over time, so applicants typically confirm the current status in the active FOA record). The announcement lists an award ceiling of $500,000, while the number of expected awards is not specified in the excerpt provided.

Taken together, this FOA is best viewed as an R01-based route for running a carefully planned, lower-risk clinical trial in communication disorders that can produce meaningful clinical insights without stepping into FDA-regulated territory or the kind of definitive efficacy-testing that would require a larger, more intensive trial program. The intent is to build the evidence base for interventions relevant to NIDCD priorities while keeping the regulatory burden and participant risk profile appropriate for an investigator-initiated R01 clinical trial.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCD Clinical Trials in Communication Disorders (R01-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 2020-12-11. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• 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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