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

Frequently Asked Questions (FAQs): NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required) - PAR-21-064

What is this funding opportunity?

This opportunity is the NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required), funding opportunity number PAR-21-064. It is an NIH program designed to support rigorous clinical trials focused on the treatment or prevention of communication disorders.

What is the main purpose of PAR-21-064?

The central purpose is to move promising interventions toward clear evidence of benefit by funding clinical trials that are well designed, carefully executed, and closely monitored, especially when studies are complex, expensive, or higher risk.

What type of grant mechanism is used?

The program uses a cooperative agreement mechanism (U01). Under a U01, the funded research is conducted with substantial scientific involvement from NIDCD rather than a more hands-off relationship typical of many standard research grants.

How is a U01 cooperative agreement different from a standard NIH research grant?

Under this U01 structure, NIDCD has substantial scientific involvement in the project. The FOA describes ongoing interaction, oversight, and guidance intended to strengthen trial planning and execution, rather than minimal involvement after award.

Will NIDCD staff be involved in the funded project?

Yes. The FOA specifies substantial scientific involvement from NIDCD, including an NIDCD Project Scientist who works alongside the investigative team to support planning, oversight, and execution.

What kinds of studies does this FOA support?

This FOA supports clinical trials in communication disorders that focus on treatment or prevention and are intended to provide clear evidence of benefit through rigorous design and careful monitoring.

Is a clinical trial required under this opportunity?

Yes. The opportunity is labeled "U01 - Clinical Trial Required," indicating that the application is expected to propose a clinical trial.

What kinds of clinical trials are a good fit for this U01?

The FOA is aimed at clinical trials that meet at least one "triggering" criterion indicating a greater need for oversight. These include trials that require FDA oversight, have annual direct costs at or above $500,000, are intended to formally establish efficacy (rather than early-stage exploratory testing), or involve a higher risk of potentially causing physical or psychological harm.

What does it mean that the trial is intended to "formally establish efficacy"?

Based on the FOA description, this mechanism is intended for trials aimed at a definitive efficacy determination, as opposed to early-stage exploratory testing.

What cost level is this FOA designed for?

This FOA is designed for larger studies. It specifically notes trials with annual direct costs at or above $500,000 as a triggering criterion, and it also notes that applications with annual direct costs of $700,000 or more may fit within scope as well.

Does the FOA require FDA oversight?

FDA oversight is not presented as a universal requirement, but trials that require FDA oversight are explicitly identified as appropriate candidates for this U01 mechanism.

What does "higher risk" mean in the context of this FOA?

The FOA indicates that this mechanism is appropriate for trials that carry a higher risk of potentially causing physical or psychological harm, which is one of the criteria signaling a greater need for oversight and monitoring.

How many clinical trials can be proposed in one application?

Only one clinical trial may be proposed per U01 application under this opportunity. The application is expected to focus on a single, clearly defined trial with a full operational plan.

Who can apply for this funding opportunity?

Eligibility is broad across many U.S.-based organizational types. 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.

Are minority-serving institutions and community-based organizations eligible?

Yes. The FOA highlights additional eligible categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, and regional organizations.

Are U.S. federal agencies eligible to apply?

Yes. The FOA includes eligible federal government agencies among the listed eligible applicant categories.

Are U.S. territories or possessions eligible to apply?

Yes. The FOA lists U.S. territories or possessions as eligible.

Can non-U.S. (foreign) organizations apply as the main applicant?

No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply under this opportunity.

Can a non-domestic component of a U.S. organization apply?

No. Non-domestic components of U.S. organizations are also not eligible to apply.

Are foreign components allowed at all?

Yes, in a limited way. While non-U.S. entities cannot apply as the main applicant, foreign components are allowed when they meet the NIH definition in the NIH Grants Policy Statement and are well justified as part of the overall project, with the primary applicant remaining eligible and U.S.-based.

What NIH institute is associated with this program?

This opportunity is associated with NIDCD (National Institute on Deafness and Other Communication Disorders).

What is the funding instrument and funding type?

The funding instrument is a cooperative agreement (U01). The opportunity is categorized as discretionary funding.

What is the broad activity category for this opportunity?

The FOA is listed under the health funding activity category.

What CFDA number is associated with this opportunity?

The opportunity is associated with CFDA number 93.173.

What is the closing date listed for this opportunity?

The source information lists an original closing date of 2023-10-10.

When was this opportunity created?

The creation date listed in the source information is 2020-12-11.

Should applicants confirm whether the FOA is still active and what the current due dates are?

Yes. The information notes that applicants would typically confirm the current status, active submission dates, and any reissued versions on NIH/Grants.gov because NIH opportunities can be updated, extended, or replaced over time.

What kind of project is this opportunity best suited for?

This program is best suited for investigators proposing a single, later-stage or higher-stakes communication-disorders clinical trial where 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.