Opportunity Information: Apply for PAR 15 117
Apply for PAR 15 117
- 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 Feb 10, 2015 and posted on Feb 10, 2015.
- Applicants must submit their applications by Oct 10, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) County governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Small businesses Independent school districts State governments Public housing authorities/Indian housing authorities Nonprofits having 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) For profit organizations other than small businesses Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34) (Funding Opportunity Number PAR 15-117) is a National Institutes of Health cooperative agreement designed to help researchers prepare a high-quality, definitive phase III clinical trial focused on communication disorders. The central purpose is not to run the full trial itself, but to support the detailed planning work needed to make a later phase III efficacy trial rigorous, feasible, and ready to launch. NIDCD is specifically emphasizing well designed and well executed multicenter, randomized phase III trials that can reliably identify effective interventions for the treatment or prevention of disorders related to hearing, balance, smell, taste, voice, speech, and language.
This U34 mechanism supports investigators in refining the phase III protocol and standardizing trial procedures across participating sites, with a major required product being a comprehensive Manual of Procedures (MOP). The MOP is meant to spell out, in operational detail, how the study will actually be conducted across centers, including consistent implementation of recruitment, eligibility screening, randomization, intervention delivery, outcome assessments, data collection, quality control, and other trial operations. NIDCD points applicants to an example MOP on its clinical trials website, underscoring that the expectation is a complete and practical document that can be used to train study staff and ensure consistency across sites. Because this is a cooperative agreement, the award is structured as an active collaboration between the funded research team and an NIDCD Project Scientist, reflecting a shared role in planning and ensuring the trial design and procedures meet the level of rigor expected for phase III.
A key feature of the announcement is the strong encouragement for applicants to consult with NIDCD scientific and research staff before submitting an application. This kind of pre-application interaction is intended to improve alignment with NIDCD priorities, clarify expectations for the planning deliverables, and address major design or feasibility issues early, before the application is finalized. In practice, this consultation can help applicants confirm that they are proposing an appropriate phase III-ready question, that the multicenter approach is justified, and that the planning activities are sufficient to de-risk the later definitive trial.
The opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument, with an activity focus in health and a CFDA listing of 93.173 (Research Related to Deafness and Communication Disorders). There is no cost sharing or matching requirement. The announcement was originally posted on February 10, 2015, with a closing date of October 10, 2017, and an archive date of November 10, 2017, meaning it is no longer active but remains an important reference for how NIDCD structures planning support for large phase III trials.
Eligibility for this FOA is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses and other for-profit entities), independent school districts, and a wide range of government entities (city/township, county, state, special district governments, and public housing authorities/Indian housing authorities). The eligibility list also explicitly includes tribal governments and tribal organizations, as well as a wide range of mission-driven and community-focused institutions such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, Asian American and Native American Pacific Islander-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), faith-based and community-based organizations, and U.S. territories or possessions. The FOA also indicates that non-domestic (non-U.S.) entities/foreign organizations and regional organizations can be eligible, reflecting NIDCDs openness to strong trial planning efforts that may require broader collaborations.
Overall, PAR 15-117 is best understood as a structured bridge between earlier-stage clinical research and a full-scale phase III efficacy trial. It funds the intensive planning and harmonization work needed to move from a promising intervention and preliminary evidence to a multicenter randomized trial that can deliver clear, practice-changing answers. For applicants, the main takeaway is that success hinges on demonstrating readiness to finalize a rigorous phase III protocol and producing an unusually detailed, implementation-ready Manual of Procedures in close coordination with NIDCD staff.
FAQs: NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34) - PAR 15-117
What is PAR 15-117 (U34) from NIDCD?
PAR 15-117 is a National Institute on Deafness and Other Communication Disorders (NIDCD) Funding Opportunity Announcement for a U34 cooperative agreement that supports planning for a phase III clinical trial in communication disorders.
What is the main purpose of this U34 planning grant?
The central purpose is to fund the detailed planning work needed to prepare a later, definitive phase III efficacy clinical trial. It is meant to help investigators refine the protocol and standardize procedures so a future multicenter trial can be rigorous, feasible, and ready to launch.
Does this grant fund the full phase III clinical trial?
No. The stated purpose is planning for a later phase III trial, not running the full phase III trial itself.
What kinds of clinical trials is NIDCD emphasizing in this opportunity?
NIDCD specifically emphasizes well designed and well executed multicenter, randomized phase III trials that can reliably identify effective interventions for the treatment or prevention of disorders related to hearing, balance, smell, taste, voice, speech, and language.
What disorders or research areas are in scope for this FOA?
The focus is on communication disorders, including disorders related to hearing, balance, smell, taste, voice, speech, and language.
What is the funding instrument and what does it imply for how the award is managed?
The opportunity uses a cooperative agreement funding instrument. This means the award is structured as an active collaboration between the funded research team and NIDCD staff, including an NIDCD Project Scientist, reflecting shared involvement in planning and ensuring the trial design and procedures meet phase III expectations.
Who from NIDCD participates during the project?
An NIDCD Project Scientist is part of the cooperative agreement structure, indicating active collaboration with the research team during the planning process.
What are the key planning activities supported by the U34?
The U34 supports refining the phase III protocol and standardizing trial procedures across participating sites so that implementation is consistent in a later multicenter trial.
What is a Manual of Procedures (MOP) and why is it required?
A Manual of Procedures (MOP) is a comprehensive, operational document describing how the study will be conducted across centers. A major required product under this FOA is a complete MOP intended to train study staff and ensure consistent trial conduct across sites.
What kinds of details is the MOP expected to include?
The MOP is expected to spell out, in operational detail, how trial activities will be carried out across centers, including recruitment, eligibility screening, randomization, intervention delivery, outcome assessments, data collection, quality control, and other trial operations.
Does NIDCD provide guidance or examples for developing the MOP?
Yes. NIDCD points applicants to an example MOP on its clinical trials website, signaling an expectation for a complete and practical document that can be used to train staff and maintain consistency across sites.
Is pre-application contact with NIDCD encouraged?
Yes. Applicants are strongly encouraged to consult with NIDCD scientific and research staff before submitting an application.
What is the point of consulting NIDCD staff before applying?
Pre-application consultation is intended to improve alignment with NIDCD priorities, clarify expectations for planning deliverables, and surface major design or feasibility issues early. It can help confirm that the proposed research question is appropriate for a phase III-ready effort, that a multicenter approach is justified, and that the planning activities are sufficient to reduce risk for the later definitive trial.
What type of funding category is this opportunity?
It is categorized as discretionary funding.
What is the CFDA listing associated with this FOA?
The CFDA listing is 93.173, titled Research Related to Deafness and Communication Disorders.
Is there a cost sharing or matching requirement?
No. The FOA states there is no cost sharing or matching requirement.
Is this funding opportunity still open?
No. The announcement was originally posted on February 10, 2015, had a closing date of October 10, 2017, and an archive date of November 10, 2017. It is no longer active, but may still be useful as a reference for how NIDCD structures phase III trial planning support.
When was the FOA posted, closed, and archived?
It was posted February 10, 2015; it closed October 10, 2017; and it was archived November 10, 2017.
What types of organizations are eligible to apply?
Eligibility is broad and includes many U.S. and non-U.S. organizations. Examples listed include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses), independent school districts, and many types of government entities.
Are government entities eligible applicants?
Yes. The eligibility list includes city/township governments, county governments, state governments, special district governments, and public housing authorities/Indian housing authorities.
Are tribal governments and tribal organizations eligible?
Yes. The eligibility list explicitly includes tribal governments and tribal organizations.
Are minority-serving institutions and community-focused organizations included in eligibility?
Yes. The eligibility list explicitly includes institutions such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, Asian American and Native American Pacific Islander-serving institutions, TCCUs, as well as faith-based and community-based organizations.
Are U.S. territories or possessions included in eligibility?
Yes. The FOA includes U.S. territories or possessions in the eligibility list.
Are non-U.S. (foreign) organizations eligible?
Yes. The FOA indicates that non-domestic (non-U.S.) entities/foreign organizations and regional organizations can be eligible.
What is the overall role of this U34 in the clinical research pipeline?
It functions as a structured bridge between earlier-stage clinical research and a full-scale phase III efficacy trial by funding intensive planning and harmonization work needed to move from preliminary evidence to a multicenter randomized trial capable of delivering clear answers.
What is the single biggest takeaway for applicants described in the FOA summary?
Success depends on demonstrating readiness to finalize a rigorous phase III protocol and producing an unusually detailed, implementation-ready Manual of Procedures in close coordination with NIDCD staff.
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