Opportunity Information: Apply for PAR 15 116
Apply for PAR 15 116
- 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 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: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public and State controlled institutions of higher education Private institutions of higher education City or township governments Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Small businesses For profit organizations other than small businesses State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments.
- 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
The NIDCD Phase I/II/III Clinical Trials in Communication Disorders (U01) funding opportunity (PAR 15-116) is a National Institutes of Health (NIH) cooperative agreement designed to support well planned, carefully executed clinical trials aimed at treating or preventing communication disorders. The core purpose is to move promising interventions forward through the clinical trial pipeline by funding phase I and phase II studies that focus on early testing and preliminary efficacy, as well as phase III studies that are intended to establish definitive efficacy. In other words, the program is meant to generate strong clinical evidence about whether an intervention truly works, with an emphasis on rigorous design, solid operational planning, and high quality trial execution.
This FOA uses the U01 mechanism, which means it is a cooperative agreement rather than a traditional research grant. Under a cooperative agreement, the funded research team leads the study, but NIDCD program staff (specifically an NIDCD Project Scientist) are expected to have substantial scientific and programmatic involvement during the conduct of the trial. Applicants should be prepared for a more collaborative relationship with the Institute than they would have under mechanisms where NIH involvement is more hands-off. That typically implies more structured coordination around milestones, protocol decisions, performance monitoring, and trial management expectations.
A major operational requirement applies to phase III clinical trial applications: they must include a complete, detailed Manual of Procedures (MOP) in the appendix. The MOP is essentially the playbook for running the trial consistently across staff, sites, and time. It normally covers step-by-step procedures for recruitment, screening, consent, randomization (if applicable), intervention delivery, assessments, safety monitoring, data collection, data management, quality assurance, training and certification of personnel, protocol deviations, reporting workflows, and other key operational elements that ensure the study can be carried out reliably and reproducibly. The FOA points applicants to an NIDCD example MOP on the Institute's clinical trials site to clarify the level of detail expected. For teams that are not yet ready with a phase III-ready operations manual, NIDCD highlights the companion planning mechanism, the NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34, PAR 15-117), which can be used to do preparatory work and develop the MOP and other essential infrastructure before submitting a full phase III U01 application.
From an administrative standpoint, this opportunity is categorized as discretionary funding and falls under the health funding activity category. The CFDA number is 93.173 (Research Related to Deafness and Communication Disorders). It does not require cost sharing or matching, which can simplify budgeting for applicants. The FOA was posted and created on February 10, 2015, with an original and current closing date of October 10, 2017, and an archive date of November 10, 2017, meaning it is no longer open for new submissions under that specific announcement, though similar or reissued NIH opportunities may exist.
Eligibility is broad and includes many common research-performing organizations and governmental units. Eligible applicants include public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status), for-profit organizations (including small businesses and other for-profits), independent school districts, and various levels of government (city/township, county, state, special district), as well as public housing authorities/Indian housing authorities. The eligibility list also explicitly extends to a wide range of mission-driven and underserved-serving institutions and organizations, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), along with federally recognized tribal governments and other tribal organizations. It also allows certain non-U.S. entities (foreign organizations), regional organizations, and U.S. territories or possessions, as described in the FOA's eligibility section.
For those seeking the official announcement details, the FOA is available through the NIH Grants Guide at http://grants.nih.gov/grants/guide/pa-files/PAR-15-116.html. For access or technical issues related to the posting, the contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
What is the NIDCD Phase I/II/III Clinical Trials in Communication Disorders (U01) funding opportunity?
It is a National Institutes of Health (NIH) cooperative agreement funding opportunity from the National Institute on Deafness and Other Communication Disorders (NIDCD) intended to support well planned, carefully executed clinical trials that aim to treat or prevent communication disorders.
What is the FOA number and title?
The FOA is PAR 15-116 and it is titled "NIDCD Phase I/II/III Clinical Trials in Communication Disorders (U01)."
What is the main purpose of this program?
The core purpose is to move promising interventions through the clinical trial pipeline by supporting phase I and phase II studies focused on early testing and preliminary efficacy, and phase III studies intended to establish definitive efficacy. The overall goal is to generate strong clinical evidence about whether an intervention works using rigorous design and high quality trial execution.
Which clinical trial phases can be supported under this FOA?
This opportunity supports phase I, phase II, and phase III clinical trials in communication disorders.
What is the difference between phase I/II and phase III expectations as described here?
Phase I and II studies are described as focusing on early testing and preliminary efficacy, while phase III studies are intended to establish definitive efficacy. The FOA emphasizes rigorous design, solid operational planning, and strong execution across all phases, with an additional major operational requirement specifically highlighted for phase III applications.
What funding mechanism does this FOA use?
The FOA uses the U01 mechanism, which is a cooperative agreement rather than a traditional research grant.
What does a U01 cooperative agreement mean for the relationship with NIDCD?
Under a cooperative agreement, the funded research team leads the study, but NIDCD program staff are expected to have substantial scientific and programmatic involvement during the conduct of the trial. Applicants should be prepared for a more collaborative relationship than under more hands-off mechanisms.
Who at NIDCD is expected to be involved during the trial?
The FOA specifies that NIDCD program staff, specifically an NIDCD Project Scientist, are expected to have substantial involvement during trial conduct.
What kinds of activities might involve coordination with NIDCD under this cooperative agreement?
The FOA indicates this typically includes structured coordination around milestones, protocol decisions, performance monitoring, and trial management expectations.
Is there any special application requirement for phase III clinical trials?
Yes. Phase III clinical trial applications must include a complete, detailed Manual of Procedures (MOP) in the appendix.
What is a Manual of Procedures (MOP) in the context of this FOA?
The MOP is described as the playbook for running the trial consistently across staff, sites, and time. It is intended to ensure the study can be carried out reliably and reproducibly through detailed operational guidance.
What topics are typically covered in the phase III Manual of Procedures (MOP)?
The FOA notes that an MOP normally covers step-by-step procedures for recruitment, screening, consent, randomization (if applicable), intervention delivery, assessments, safety monitoring, data collection, data management, quality assurance, training and certification of personnel, protocol deviations, reporting workflows, and other key operational elements.
Where should the phase III Manual of Procedures (MOP) be included in the application?
The FOA states the MOP must be included in the appendix for phase III clinical trial applications.
Does NIDCD provide guidance on what a phase III MOP should look like?
Yes. The FOA points applicants to an NIDCD example MOP on the Institute's clinical trials site to clarify the level of detail expected.
What if a team is not ready to produce a phase III-ready MOP yet?
NIDCD highlights a companion planning mechanism: the NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34, PAR 15-117), which can be used for preparatory work and to develop the MOP and other essential infrastructure before submitting a full phase III U01 application.
What is the companion planning FOA mentioned for phase III preparation?
The companion planning mechanism referenced is the NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34), FOA number PAR 15-117.
What is the CFDA number associated with this opportunity?
The CFDA number is 93.173, listed as "Research Related to Deafness and Communication Disorders."
How is this funding opportunity categorized administratively?
It is categorized as discretionary funding and falls under the health funding activity category.
Is cost sharing or matching required?
No. The opportunity does not require cost sharing or matching.
When was this FOA posted and created?
The FOA was posted and created on February 10, 2015.
What were the closing date and archive date for PAR 15-116?
The original and current closing date was October 10, 2017, and the archive date was November 10, 2017.
Is this FOA currently open for new submissions?
No. Based on the closing and archive dates provided, PAR 15-116 is no longer open for new submissions under that specific announcement.
Could similar opportunities still exist even though this specific FOA is closed?
Yes. The information provided notes that similar or reissued NIH opportunities may exist, even though PAR 15-116 is no longer open.
What types of organizations are eligible to apply?
Eligibility is broad and includes public and private institutions of higher education; nonprofits (with and without 501(c)(3) status); for-profit organizations (including small businesses and other for-profits); independent school districts; and multiple levels of government (city/township, county, state, special district), as well as public housing authorities/Indian housing authorities.
Are minority-serving institutions specifically included in eligibility?
Yes. The eligibility list explicitly includes Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs).
Are tribal governments and tribal organizations eligible?
Yes. The eligibility list includes federally recognized tribal governments and other tribal organizations.
Are non-U.S. entities eligible to apply?
Yes. The eligibility section is described as allowing certain non-U.S. entities (foreign organizations), regional organizations, and U.S. territories or possessions, as described in the FOA's eligibility section.
Where can applicants find the official FOA announcement text?
The official announcement is available through the NIH Grants Guide at http://grants.nih.gov/grants/guide/pa-files/PAR-15-116.html.
Who should be contacted for access or technical issues related to the posting?
The contact listed for access or technical issues is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Browse more opportunities from the same category: Health
Next opportunity: Office of Innovation and Improvement (OII) Arts in Education National Program (AENP) CFDA Number 84.351F
Previous opportunity: NIDCD Planning Grant for Phase III Clinical Trials in Communication Disorders (U34)
USGrants.org Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for PAR 15 116
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (PAR 15 116) also looked into and applied for these:
| Funding Opportunity |
|---|
| High End Instrumentation (HEI) Grant Program (S10) Apply for PAR 15 118 Funding Number: PAR 15 118 Agency: National Institutes of Health Category: Health Funding Amount: $2,000,000 |
| Molecular Mechanisms of Combination Adjuvants (MMCA)(U01) Apply for RFA AI 15 005 Funding Number: RFA AI 15 005 Agency: National Institutes of Health Category: Health Funding Amount: $350,000 |
| Improving the Health of People with Disabilities through State Based Public Health Programs DD12 1204 Apply for CDC RFA DD15 1502 Funding Number: CDC RFA DD15 1502 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $300,000 |
| Improving Timeliness of Newborn Screening Diagnosis Apply for HRSA 15 098 Funding Number: HRSA 15 098 Agency: Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
| FY15 Announcement of the Anticipated Availability of Funds for Research Conferences on Research Integrity Apply for IR ORI 15 002 Funding Number: IR ORI 15 002 Agency: Office of the Assistant Secretary for Health Category: Health Funding Amount: $50,000 |
| The National Syndromic Surveillance Program Enhancing Syndromic Surveillance Capacity and Practice Apply for CDC RFA OE15 1502 Funding Number: CDC RFA OE15 1502 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $400,000 |
| FY15 Announcement of Anticipated Availability of Funds for Family Planning Services Grants Commonwealth of the Northern Mariana Islands (entire CNMI) Apply for PA FPH 15 028 Funding Number: PA FPH 15 028 Agency: Office of the Assistant Secretary for Health Category: Health Funding Amount: $180,000 |
| Organized Approaches to Increase Colorectal Cancer Screening Apply for CDC RFA DP15 1502 Funding Number: CDC RFA DP15 1502 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $1,800,000 |
| AHRQ Health Services Research Projects Making Health Care Safer in Ambulatory Care Settings and Long Term Care Facilities (R01) Apply for RFA HS 15 002 Funding Number: RFA HS 15 002 Agency: Agency for Health Care Research and Quality Category: Health Funding Amount: $500,000 |
| Community Foods Program Apply for USDA NIFA CFP 004920 Funding Number: USDA NIFA CFP 004920 Agency: National Institute of Food and Agriculture Category: Health Funding Amount: $250,000 |
| Autism Intervention Research Network on Behavioral Health (AIR B) Apply for HRSA 15 091 Funding Number: HRSA 15 091 Agency: Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
| Office of Tribal Self Governance Negotiation Cooperative Agreement Apply for HHS 2015 IHS TSGN 0001 Funding Number: HHS 2015 IHS TSGN 0001 Agency: Indian Health Service Category: Health Funding Amount: $48,000 |
| Strengthening a Regional Public Health Surveillance, Capacity and Laboratory Network for Central America with the Secretaria General del Sistema de la Integracion Centroamericana (SG SICA) / Consejo de Ministros de Salud de Centroamerica (COMISCA) Apply for CDC RFA GH15 1607 Funding Number: CDC RFA GH15 1607 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $2,000,000 |
| 2015 Campus Suicide Prevention Grant Apply for SM 15 008 Funding Number: SM 15 008 Agency: Substance Abuse Mental Health Services Adminis. Category: Health Funding Amount: $102,000 |
| Autism Intervention Research Network on Physical Health (AIR P) Apply for HRSA 15 092 Funding Number: HRSA 15 092 Agency: Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
| Local Capacity Initiative Apply for SOL 486 15 000001 Funding Number: SOL 486 15 000001 Agency: Thailand USAID Bangkok Category: Health Funding Amount: $2,700,000 |
| Conducting Public Health Research in Georgia Apply for RFA GH 15 002 Funding Number: RFA GH 15 002 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: Case Dependent |
| Capacity Building Initiative for Substance Abuse (SA) and HIV Prevention Services for At Risk Racial/Ethnic Minority Youth and Young Adults (HIV CBI) Apply for SP 15 005 Funding Number: SP 15 005 Agency: Substance Abuse Mental Health Services Adminis. Category: Health Funding Amount: $300,000 |
| Conducting Operational Research to Identify Numbers and Rates, Determine Needs, and Integrate Services to Mitigate Morbidity and Mortality Among Internally Displaced Persons Affected by Emergencies Apply for RFA GH 15 008 Funding Number: RFA GH 15 008 Agency: Centers for Disease Control and Prevention Category: Health Funding Amount: $500,000 |
| Hospital Preparedness Program (HPP) Ebola Preparedness and Response Activities Apply for EP U3R 15 002 Funding Number: EP U3R 15 002 Agency: Assistant Secretary for Preparedness and Response Category: Health Funding Amount: $15,229,780 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Subscribe to Leads
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "PAR 15 116", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.