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.Apply for PA 18 334
- 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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Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled "NIDCD Clinical Trials in Communication Disorders (R01 - Clinical Trial Required)."
Which agency is offering this grant?
The National Institute on Deafness and Other Communication Disorders (NIDCD), which is part of the National Institutes of Health (NIH), is offering this funding opportunity.
What is the funding mechanism?
This opportunity uses the R01 mechanism and is specifically for applications that include a clinical trial (clinical trial required).
What is the Funding Opportunity Number and CFDA number?
The Funding Opportunity Number is PA-18-334 and the CFDA number is 93.173.
What is the overall purpose of this FOA?
The purpose 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.
What kinds of disorders or clinical areas does NIDCD consider in scope here?
The FOA targets communication-related disorders and functions, including hearing, balance, smell, taste, voice, speech, and language.
What type of research study is expected under this FOA?
This FOA is intended for investigator-initiated clinical trials in human participants, where the study is structured as a clinical trial and is designed to test promising interventions in a relatively low-risk, lower regulatory complexity setting.
Is this FOA specifically for low-risk clinical trials?
Yes. A defining feature of this opportunity is that it is specifically intended for low-risk clinical trials.
What requirements must a proposed trial meet to be considered responsive as "low-risk" under this FOA?
To be considered responsive based on the provided information, proposed trials must: (1) fit within the FOA budget limits (with an award ceiling listed as $500,000), (2) not require FDA oversight, (3) not be designed to formally establish efficacy the way a pivotal or registrational trial would, and (4) present low risk for physical or psychological harm to participants.
Does the FOA allow trials that require FDA oversight?
No. The FOA states that, to be responsive, proposed trials must not require U.S. Food and Drug Administration (FDA) oversight.
Can this R01 be used for a pivotal or registrational trial designed to formally establish efficacy?
No. To be responsive, the trial must not be designed to formally establish efficacy in the way a pivotal or registrational trial would.
What does "low risk" mean in the context of this FOA?
Based on the provided description, "low risk" means the trial presents low risk for causing physical or psychological harm to participants and avoids higher regulatory complexity (including not requiring FDA oversight).
How many clinical trials should be included in one R01 application under this FOA?
The FOA recommends proposing only one clinical trial per R01 application.
Is proposing only one clinical trial required or recommended?
Based on the provided information, it is recommended. The FOA presents this as guidance to support clarity and feasibility in the application.
Why does the FOA recommend only one clinical trial per R01 application?
The recommendation is described as a guardrail for clarity and feasibility: it encourages applicants to focus aims, concentrate resources, and present a coherent study design rather than bundling multiple trials into a single submission.
What if my proposed clinical trial is not low risk or is considered high risk?
If a proposed study does not meet the low-risk criteria or rises to a high-risk level, the FOA directs applicants to a companion funding opportunity using a cooperative agreement mechanism (U01): PAR-18-340, "NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders."
What is the companion FOA for higher-risk or more complex clinical trials?
The companion pathway identified is PAR-18-340, "NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders" (U01 mechanism).
How is the R01 pathway different from the U01 companion pathway mentioned?
Based on the description provided, the R01 pathway is positioned for ethically and operationally straightforward, lower-risk trials, while higher-risk trials may require closer NIH involvement and oversight typical of U01 cooperative agreements.
Who is eligible to apply?
Eligibility is broad and includes many U.S. organizations and government entities, including: state/county/city/township/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; nonprofits (both 501(c)(3) and non-501(c)(3), other than institutions of higher education); for-profit organizations (including small businesses); and other categories as permitted by NIH policy.
Are small businesses eligible to apply?
Yes. Small businesses are explicitly included among the eligible applicant organizations listed.
Are for-profit organizations eligible to apply?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed separately as eligible.
Are nonprofit organizations eligible to apply?
Yes. The eligible applicants include nonprofit organizations with 501(c)(3) status and nonprofits without 501(c)(3) status (other than institutions of higher education).
Are colleges and universities eligible?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible.
Are tribal entities eligible?
Yes. Federally recognized Native American tribal governments are eligible, and the FOA also highlights tribal governments that are not federally recognized as additional eligible applicants.
Are U.S. territories or possessions eligible to apply?
Yes. The FOA explicitly highlights U.S. territories or possessions among additional eligible applicants.
Are foreign (non-U.S.) organizations eligible?
Yes. The FOA highlights non-U.S. entities (foreign organizations) as eligible.
Does the FOA encourage applications from specific institution types or communities?
Yes. The FOA explicitly highlights a range of additional eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based and community-based organizations, eligible federal agencies, and regional organizations.
What is the award ceiling mentioned for this opportunity?
The excerpt lists an award ceiling of $500,000.
Is the number of expected awards stated?
No. The number of expected awards is not specified in the excerpt provided.
What is the funding category and award type described?
The excerpt describes it as a discretionary grant opportunity administered by NIH under the health funding activity category.
When was this opportunity created, and what closing date is listed in the provided information?
The excerpt states the opportunity was created on November 13, 2017, and an original closing date is listed as December 11, 2020.
Should applicants rely solely on the listed closing date in the excerpt?
No. The provided information notes that NIH opportunities can have multiple receipt dates or be reissued over time, and applicants typically confirm the current status in the active FOA record.
What kinds of outcomes is NIDCD hoping to support through this FOA?
The FOA is aimed at generating strong clinical evidence that advances diagnosis, prevention, or treatment relevant to NIDCD priorities, while keeping participant risk and regulatory burden appropriate for an investigator-initiated R01 clinical trial.
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