Opportunity Information: Apply for PAR 12 124
Apply for PAR 12 124
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34)" 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.)
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Native American tribal organizations (other than Federally recognized tribal governments) County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Small businesses Private institutions of higher education State governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Independent school districts For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district 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 Planning Grant for Phase III Clinical Trials in Communication Disorders (U34) (Funding Opportunity Number PAR-12-124) is a National Institutes of Health cooperative agreement designed to help research teams properly plan and fully prepare for a large, definitive Phase III clinical trial aimed at testing the efficacy of an intervention to treat or prevent communication disorders. The central idea is that strong Phase III trials do not start with recruitment and randomization; they start with careful, documented planning that locks down the protocol, standardizes procedures across sites, and reduces the avoidable design and operational problems that can undermine results. Through this FOA, NIDCD supports a structured planning period in close collaboration with NIDCD staff (which is what distinguishes a cooperative agreement from a more investigator-directed grant mechanism).
A key feature of this opportunity is that it functions as the usual gateway to NIDCD’s Phase III clinical trial implementation mechanism, the NIDCD Phase III Clinical Trials in Communication Disorders (U01) (PAR-12-123). In general, NIDCD will only accept U01 Phase III trial applications from teams that previously received this U34 planning award, unless NIDCD program staff explicitly agrees to accept a Phase III application from an investigator who did not use the planning grant first. In practice, that means the U34 is meant to be the standard on-ramp: teams use the planning award to finalize trial readiness, then move forward with a U01 application to actually run the Phase III study.
The main deliverable supported by the U34 is a complete, detailed Manual of Procedures (MOP). The MOP is essentially the operational blueprint for the trial and is expected to capture, in an implementable way, exactly how the study will be conducted. This includes the kinds of details that make a multi-site clinical trial reproducible and auditable, such as participant flow and scheduling, staff roles and training requirements, standardized administration of intervention and control conditions, fidelity monitoring, data collection procedures, safety monitoring and reporting pathways, data management and quality control, and the rules for handling protocol deviations, missing data, and other common real-world issues. NIDCD points applicants to an example of a full MOP on its clinical trials website, signaling that a high level of specificity and completeness is expected. Importantly, the later U01 application must include the complete, detailed MOP in the appendix, so the U34 period is explicitly structured to produce a submission-ready document that supports rigorous review and reliable execution.
Administratively, this is a discretionary funding opportunity under the health activity category, associated with CFDA 93.173 (Research Related to Deafness and Communication Disorders). The award instrument type is a cooperative agreement, meaning the investigator works in partnership with NIDCD program staff during the planning process. The opportunity does not require cost sharing or matching. The award ceiling listed is $200,000. The announcement was posted and created on March 16, 2012, with an original and current closing date of February 4, 2015, and an archive date of March 7, 2015 (so this specific FOA is no longer active, but it is still useful as a reference for how NIDCD structures Phase III trial planning and what it expects from applicants).
Eligibility is broad and includes a wide range of organizational types across the public, private, nonprofit, and education sectors. Eligible applicants include federal, state, county, city/township, special district, and certain housing authorities; public and state-controlled institutions of higher education as well as private institutions of higher education; independent school districts; nonprofits with and without 501(c)(3) status; for-profit organizations (including small businesses and other for-profits); and Native American tribal governments (both federally recognized and other than federally recognized), along with tribal organizations and tribally controlled colleges and universities. The FOA also explicitly notes eligibility for various mission-focused institutions and organizations, such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and it allows non-U.S. entities (foreign institutions), non-U.S. components of U.S. organizations, and other foreign components as defined by NIH policy.
Overall, the U34 is best understood as a trial-readiness and trial-standardization award: it funds the work needed to transform a promising intervention and a general study concept into a Phase III-ready package with clear procedures, tight operational definitions, and a documented plan that can be implemented consistently and reviewed confidently. The emphasis throughout is on rigor, feasibility, and execution quality, with the MOP serving as the concrete product that demonstrates the team is prepared to run a robust, well-designed, and well-executed Phase III clinical trial in communication disorders.
FAQs: NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34) - PAR-12-124
What is the NIDCD U34 Planning Grant (PAR-12-124)?
The NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34) is an NIH cooperative agreement intended to support a structured planning period for a large, definitive Phase III clinical trial. Its purpose is to help research teams fully prepare to test the efficacy of an intervention to treat or prevent communication disorders, with a strong emphasis on detailed, documented planning before recruitment and randomization begin.
What is the main purpose of this U34 award?
The U34 is designed to fund trial-readiness work: finalizing the protocol, standardizing procedures across sites, and addressing operational details that can otherwise undermine trial results. The focus is on rigor, feasibility, and execution quality so the eventual Phase III clinical trial can be implemented consistently and reviewed confidently.
What does it mean that this is a "cooperative agreement"?
A cooperative agreement means the planning effort is carried out in close collaboration with NIDCD staff. This partnership aspect is a defining feature of the mechanism, distinguishing it from more investigator-directed grant mechanisms.
How does the U34 relate to NIDCD's Phase III implementation mechanism (U01)?
This U34 planning award is generally the gateway to NIDCD's Phase III clinical trial implementation mechanism, the NIDCD Phase III Clinical Trials in Communication Disorders (U01) (PAR-12-123). In general, NIDCD will only accept U01 Phase III trial applications from teams that previously received this U34 planning award, unless NIDCD program staff explicitly agrees to accept a Phase III application from an investigator who did not complete the U34 first.
Is the U34 meant to fund the actual Phase III clinical trial?
No. The U34 supports planning and preparation for a Phase III clinical trial. The actual implementation of the Phase III trial is associated with the separate U01 mechanism (PAR-12-123).
What is the primary deliverable expected from the U34 planning period?
The primary deliverable is a complete, detailed Manual of Procedures (MOP). The MOP is the operational blueprint for how the trial will be conducted and is expected to be implementable, reproducible, and auditable, especially for multi-site studies.
What is a Manual of Procedures (MOP) in this context?
The MOP is a detailed document that specifies exactly how the clinical trial will operate in practice. It is intended to lock down the protocol and standardize procedures so that the trial can be executed consistently across sites and staff.
What kinds of details is the MOP expected to include?
Based on the opportunity description, the MOP is expected to address practical, trial-critical operational details such as participant flow and scheduling; staff roles and training requirements; standardized administration of intervention and control conditions; fidelity monitoring; data collection procedures; safety monitoring and reporting pathways; data management and quality control; and rules for handling protocol deviations, missing data, and other common operational issues.
Why is the MOP so important for the later U01 application?
The U01 application must include the complete, detailed MOP in the appendix. The U34 period is structured to produce a submission-ready MOP that supports rigorous peer review and reliable execution during the implementation phase.
Does NIDCD provide guidance or examples for what a complete MOP looks like?
Yes. NIDCD points applicants to an example of a full MOP on its clinical trials website, signaling that a high level of specificity and completeness is expected in the document.
What type of clinical trial is this planning grant intended to support?
It is intended to support planning for a large, definitive Phase III clinical trial focused on testing the efficacy of an intervention to treat or prevent communication disorders.
What is the funding instrument type for this opportunity?
The award instrument is a cooperative agreement.
Is cost sharing or matching required?
No. The opportunity states that cost sharing or matching is not required.
What is the award ceiling listed for this opportunity?
The listed award ceiling is $200,000.
What is the CFDA number associated with this funding opportunity?
The opportunity is associated with CFDA 93.173, titled Research Related to Deafness and Communication Disorders.
When was this funding opportunity posted, and is it still active?
The announcement was posted and created on March 16, 2012. The original and current closing date was February 4, 2015, and the archive date was March 7, 2015. This specific FOA is no longer active, though it remains useful as a reference for how NIDCD structures Phase III trial planning and what it expects from applicants.
Who is eligible to apply?
Eligibility is broad and includes many organization types across public, private, nonprofit, and education sectors. Eligible applicants include federal, state, county, city/township, special district, and certain housing authorities; public and state-controlled institutions of higher education and private institutions of higher education; independent school districts; nonprofits with and without 501(c)(3) status; for-profit organizations (including small businesses); and Native American tribal governments (both federally recognized and other than federally recognized), as well as tribal organizations and tribally controlled colleges and universities.
Are mission-focused institutions specifically called out as eligible?
Yes. The FOA explicitly notes eligibility for various mission-focused institutions and organizations, including Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and faith-based or community-based organizations, as well as regional organizations and U.S. territories or possessions.
Are non-U.S. entities eligible to apply?
Yes. The FOA allows non-U.S. entities (foreign institutions), non-U.S. components of U.S. organizations, and other foreign components as defined by NIH policy.
What is the overall takeaway: what does the U34 fund in practical terms?
In practical terms, the U34 funds the work needed to convert a promising intervention and general study concept into a Phase III-ready package. That includes tightening operational definitions, standardizing procedures, documenting how the trial will run, and producing a complete MOP that demonstrates readiness for a robust, well-designed, and well-executed Phase III clinical trial in communication disorders.
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