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.Apply for PAR 24 050
- 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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FAQs: NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required) (PAR-24-050)
What is PAR-24-050?
PAR-24-050 is an NIH funding opportunity from the National Institute on Deafness and Other Communication Disorders (NIDCD) that supports clinical trials in communication disorders using the U01 cooperative agreement mechanism. It is specifically labeled "Clinical Trial Required," meaning the proposed work must be a clinical trial.
What is the main goal of this funding opportunity?
The goal is to fund rigorous, well designed, well executed clinical trials that can meaningfully inform clinical practice and improve patient outcomes related to communication disorders. The emphasis is on moving beyond early-stage or exploratory research and generating strong clinical evidence for interventions that are ready for formal testing in humans.
What scientific areas or conditions are included under "communication disorders" for this opportunity?
The scope includes conditions and interventions related to hearing, balance, taste, smell, voice, speech, and language.
What type of studies does NIDCD want to support through this FOA?
This FOA is intended for higher-stakes clinical trials conducted under tightly controlled and carefully monitored conditions, where the results can provide strong evidence about whether an intervention improves treatment or prevention outcomes for communication-related conditions.
What award mechanism is used and what does it mean?
The FOA uses the U01 cooperative agreement mechanism. This signals substantial scientific or programmatic involvement by NIDCD during the award. The investigative team leads and executes the study, but the project is carried out in collaboration with an NIDCD Project Scientist, with more active engagement from the institute than is typical under a standard research project grant.
How does a U01 cooperative agreement differ from a standard NIH research grant in practice?
Based on the information provided, the key difference is the cooperative structure: NIDCD staff (through an assigned Project Scientist) are more actively involved during the project. This often includes scientific coordination, milestone tracking, and engagement to ensure the trial meets the expected level of rigor for clinical research.
Does the investigator team still control and run the study?
Yes. The investigators remain responsible for leading the study and executing the protocol, while working collaboratively with NIDCD under the cooperative agreement structure.
What kinds of clinical trials are specifically targeted by this FOA?
The announcement targets clinical trials that meet any of these three conditions:
- Trials that require FDA oversight (for example, regulated drugs, biologics, or devices, including studies under IND or IDE frameworks as applicable).
- Trials intended to formally establish efficacy (designed to provide definitive evidence that an intervention works, supported by robust endpoints, appropriate control conditions, and a statistical plan capable of clear efficacy conclusions).
- Trials considered higher risk, where participation could potentially lead to physical or psychological harm (implying strong participant protections and oversight).
What does "FDA oversight" mean in the context of this opportunity?
In this FOA, FDA oversight generally refers to trials involving regulated drugs, biologics, or devices, or trials conducted under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) framework, as applicable.
What does it mean that a trial is intended to "formally establish efficacy"?
It means the study is designed to provide definitive evidence that an intervention works. The description highlights expectations such as robust endpoints, appropriate control conditions, and a statistical plan that supports clear conclusions about efficacy.
What does "higher risk" mean for trials supported under this FOA?
"Higher risk" refers to trials where participation could potentially lead to physical or psychological harm. The FOA implies that such trials will need heightened attention to human subjects protections, safety monitoring, adverse event reporting, and oversight that matches the risk profile.
What human subjects and safety expectations are implied for higher-risk trials?
The FOA emphasizes strong human subjects protections, careful safety monitoring, thorough adverse event reporting, and oversight that is appropriate for the intervention and participant population, especially when risk is higher.
Who is eligible to apply?
Eligibility is broad and includes many domestic (U.S.) applicant types listed in the excerpt, including:
- 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 501(c)(3) status (when not applying as an institution of higher education under those nonprofit categories)
- Nonprofits without 501(c)(3) status (when not applying as an institution of higher education under those nonprofit categories)
- For-profit organizations other than small businesses
- Small businesses
- Other organizations that meet NIH eligibility rules for this program
Are institutions serving underrepresented communities explicitly included as eligible applicants?
Yes. The FOA explicitly calls out additional eligible categories, including 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), and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based and community-based organizations eligible?
Yes. The FOA explicitly includes faith-based or community-based organizations as eligible applicant categories.
Are U.S. territories or possessions eligible to apply?
Yes. The eligibility description explicitly includes U.S. territories or possessions.
Are federal agencies eligible to apply?
Yes. The FOA excerpt explicitly lists eligible federal agencies among the additional eligible applicant categories.
Can a non-U.S. (foreign) organization apply as the applicant?
No. Non-domestic (non-U.S.) entities are not eligible to apply under this FOA.
Can a non-U.S. component of a U.S. organization apply?
No. Non-domestic components of U.S. organizations are not eligible to apply.
Are any international activities allowed at all?
Yes, foreign components are allowed as defined in the NIH Grants Policy Statement. This means the applicant organization must be U.S.-based and eligible, but the project can include certain international elements if they qualify as foreign components under NIH policy and are properly justified.
Which NIH institute is associated with this opportunity?
The opportunity is from the National Institute on Deafness and Other Communication Disorders (NIDCD), within the National Institutes of Health (NIH).
What is the CFDA number for this opportunity?
The CFDA number provided is 93.173.
Is this a discretionary grant mechanism?
Yes. The excerpt describes it as an NIH discretionary grant mechanism designed to support rigorous clinical trials in communication disorders.
When was this opportunity created and what is the listed closing date?
The opportunity was created on 2023-10-20, and the listed original closing date is 2026-10-27.
Does the excerpt state the maximum award amount or how many awards will be made?
No. The excerpt provided does not specify an award ceiling or the expected number of awards. It notes that applicants typically need to consult the full FOA text for budget guidance, any institute-specific caps, and details on anticipated funding levels and award counts for particular receipt dates.
What kinds of teams are a good fit for PAR-24-050?
This FOA is positioned for teams that are ready to run a consequential clinical trial in communication disorders, particularly when the trial requires FDA oversight, is designed to deliver definitive efficacy conclusions, or involves higher risk requiring enhanced oversight and careful trial governance.
What should applicants be prepared for due to the cooperative agreement structure?
Applicants should be prepared not only to conduct a high-quality clinical trial, but also to work in an active partnership with NIDCD staff (including an NIDCD Project Scientist) to meet scientific and operational expectations throughout the project period, including coordination and milestone tracking.
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