Opportunity Information: Apply for PAR 12 123
Apply for PAR 12 123
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCD Phase I/II/III Clinical Trials in Communication Disorders (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173 Research Related to Deafness and Communication Disorders.
- This funding opportunity was created on Mar 16, 2012 and posted on Mar 16, 2012.
- Applicants must submit their applications by Feb 4, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses For profit organizations other than small businesses County governments Independent school districts Private institutions of higher education City or township governments Special district governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIDCD Phase I/II/III Clinical Trials in Communication Disorders (U01) funding opportunity (PAR 12-123) is an NIH cooperative agreement designed to support rigorous clinical trials aimed at preventing or treating communication disorders. The core purpose is to move promising interventions through the clinical testing pipeline by funding Phase I and Phase II studies that focus on safety, feasibility, and preliminary efficacy, as well as Phase III trials intended to deliver definitive evidence of efficacy. In practice, this FOA is geared toward well designed, carefully controlled studies that can produce clear, credible answers about whether an intervention works, for whom it works, and under what conditions it should be used.
A key feature of this opportunity is the use of the U01 cooperative agreement mechanism, which signals substantial scientific and/or programmatic involvement from NIDCD staff compared with a typical research grant. Rather than being purely investigator-driven with minimal agency interaction, the cooperative agreement structure anticipates an active collaboration between the funded research team and an NIDCD project collaborator. This arrangement is commonly used when the sponsor wants to ensure that trial design, operational execution, oversight, and milestone-driven progress align closely with institute standards for clinical trials, particularly when the goal is to generate evidence that can influence clinical practice.
The announcement places a strong emphasis on operational readiness and high-quality trial conduct, especially for Phase III studies. Applicants proposing a Phase III clinical trial must include a complete, detailed Manual of Procedures (MOP) in the application appendix. The MOP is expected to spell out, in an implementation-ready way, how the trial will be run day to day: recruitment and screening workflows, eligibility determination, consent processes, randomization procedures (if applicable), intervention delivery and fidelity monitoring, schedules of assessments, data collection and management, adverse event reporting, staff training and certification, quality assurance, protocol deviations, and other essential operational details. NIDCD points applicants to an example MOP on its clinical trials webpage, underscoring that the institute expects Phase III applications to be mature, fully specified trials rather than conceptual plans.
For teams that are not yet ready to submit a fully developed Phase III protocol package, the FOA notes that the NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34) (PAR 12-124) can be used to assemble needed planning information and to develop the MOP. This effectively creates a pathway where investigators can use a planning award to finalize operational and procedural details and then transition to a U01 for trial execution once the study is ready for definitive testing.
Administratively, this opportunity is listed as a discretionary grant program under the NIH, with the activity focused on health and tied to CFDA 93.173 (Research Related to Deafness and Communication Disorders). It does not require cost sharing or matching funds. The opportunity was posted and created on March 16, 2012, with an original and final closing date of February 4, 2015, and an archive date of March 7, 2015, meaning it is not currently open but remains relevant as a reference point for how NIDCD structures and expects clinical trial applications in this area.
Eligibility is broad and includes small businesses, for-profit organizations (including those other than small businesses), nonprofit organizations (with or without 501(c)(3) status), public and private institutions of higher education, and a wide range of government entities (state, local, special district, and tribal). The eligibility language also explicitly includes many institution types that NIH commonly highlights for inclusion, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, and U.S. territories or possessions. Importantly, non-U.S. (foreign) institutions are eligible to apply, non-U.S. components of U.S. organizations are eligible, and foreign components as defined by NIH policy are allowed, which can be relevant for multi-site trials, international recruitment, or specialized expertise located outside the United States.
For access and administrative help, the listing directs applicants to the full FOA text via the NIH Grants Guide (linked in the announcement) and provides NIH Office of Extramural Research (OER) webmaster contact information for technical issues accessing or linking to the announcement.
Frequently Asked Questions (FAQs): NIDCD Phase I/II/III Clinical Trials in Communication Disorders (U01) - PAR 12-123
What is the PAR 12-123 funding opportunity?
PAR 12-123 is an NIH funding opportunity from the National Institute on Deafness and Other Communication Disorders (NIDCD) that uses the U01 cooperative agreement mechanism to support clinical trials in communication disorders.
What is the main purpose of this U01 program?
The purpose is to move promising interventions through the clinical testing pipeline by supporting rigorous, well-designed clinical trials that can provide clear evidence about whether an intervention works, for whom it works, and under what conditions it should be used.
What phases of clinical trials are supported under this opportunity?
This opportunity supports Phase I and Phase II clinical trials (focused on safety, feasibility, and preliminary efficacy) as well as Phase III clinical trials intended to provide definitive evidence of efficacy.
What types of studies does NIDCD emphasize for this FOA?
The FOA emphasizes well-designed, carefully controlled studies with strong operational planning and high-quality trial conduct, particularly for Phase III trials.
What does it mean that this is a U01 cooperative agreement?
A U01 cooperative agreement indicates substantial scientific and/or programmatic involvement from NIDCD staff. Rather than minimal agency interaction, the structure anticipates active collaboration between the funded research team and an NIDCD project collaborator.
How is a U01 different from a typical investigator-driven research grant?
Compared with a typical research grant, this cooperative agreement is designed for closer collaboration and oversight so that trial design, operational execution, oversight, and milestone-driven progress align with NIDCD expectations for clinical trials.
What is the Manual of Procedures (MOP), and when is it required?
For Phase III clinical trial applications, applicants must include a complete, detailed Manual of Procedures (MOP) in the application appendix. The MOP is expected to be implementation-ready and describe how the trial will operate day to day.
What operational details is the Phase III MOP expected to include?
The MOP is expected to cover key trial operations such as recruitment and screening workflows, eligibility determination, informed consent processes, randomization procedures (if applicable), intervention delivery and fidelity monitoring, schedules of assessments, data collection and management, adverse event reporting, staff training and certification, quality assurance, protocol deviations, and other essential operational details.
Why does NIDCD place strong emphasis on the MOP for Phase III trials?
NIDCD signals that Phase III applications should be mature and fully specified, not conceptual. The detailed MOP requirement reflects the expectation that the trial is operationally ready and capable of producing definitive evidence.
Is there guidance or an example MOP applicants can review?
Yes. The FOA points applicants to an example MOP on the NIDCD clinical trials webpage, indicating that NIDCD expects Phase III applications to follow a high standard of operational detail.
What if a research team is not ready to submit a fully developed Phase III trial and MOP?
The FOA notes that teams can use the NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34), PAR 12-124, to assemble needed planning information and develop the MOP before submitting a U01 for trial execution.
What is the role of the U34 planning grant (PAR 12-124) in this pathway?
The U34 planning grant is presented as a mechanism to help investigators finalize operational and procedural details (including the MOP) and then transition to a U01 once the study is ready for definitive testing.
What agency and institute sponsor this opportunity?
This opportunity is administered under NIH and is specifically associated with NIDCD for clinical trials in communication disorders.
What is the CFDA number associated with this program?
The listing ties the program to CFDA 93.173, Research Related to Deafness and Communication Disorders.
Is this opportunity currently open for applications?
No. The opportunity had an original and final closing date of February 4, 2015, and an archive date of March 7, 2015. It is not currently open, but it may still be useful as a reference for NIDCD expectations for clinical trial applications.
When was the opportunity posted and created?
The listing indicates it was posted and created on March 16, 2012.
Does this grant require cost sharing or matching funds?
No. The listing states that cost sharing or matching is not required.
Who is eligible to apply?
Eligibility is broad and includes small businesses, for-profit organizations (including those other than small businesses), nonprofit organizations (with or without 501(c)(3) status), public and private institutions of higher education, and a wide range of government entities (state, local, special district, and tribal).
Are specific institution types explicitly included in the eligibility language?
Yes. The eligibility language explicitly includes institution types NIH often highlights, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, and U.S. territories or possessions.
Are non-U.S. (foreign) institutions eligible to apply?
Yes. The eligibility information states that non-U.S. (foreign) institutions are eligible to apply.
Are non-U.S. components of U.S. organizations allowed?
Yes. The eligibility language states that non-U.S. components of U.S. organizations are eligible.
Are foreign components allowed under NIH policy?
Yes. The listing indicates that foreign components (as defined by NIH policy) are allowed, which may support multi-site trials, international recruitment, or specialized expertise located outside the United States.
Where can applicants find the full FOA text?
The listing directs applicants to the full FOA text via the NIH Grants Guide (linked in the announcement).
Who should be contacted for technical issues accessing or linking to the announcement?
The listing provides NIH Office of Extramural Research (OER) webmaster contact information for technical issues related to accessing or linking to the announcement.
What kinds of outcomes is this FOA trying to achieve from funded trials?
The FOA is aimed at generating clear, credible answers about intervention effectiveness, including whether an intervention works, which participants benefit, and under what conditions it should be used, with Phase III trials intended to provide definitive evidence of efficacy.
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