Opportunity Information: Apply for PAR 08 203
Apply for PAR 08 203
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCD Clinical Trial Planning Grant (R34)" 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 Apr 6, 2009 and posted on Jul 16, 2008.
- Applicants must submit their applications by May 7, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: For profit organizations other than small businesses Special district governments Private institutions of higher education State governments Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities County governments Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education.
- 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.
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Opportunity Summary:
The NIDCD Clinical Trial Planning Grant (R34), Funding Opportunity Number PAR 08 203, is a National Institutes of Health (NIH) grant opportunity intended to fund the planning work needed before launching a large, multicenter Phase III definitive clinical trial in areas related to deafness and communication disorders (CFDA 93.173). The central aim is not to pay for running the full trial itself, but to support the detailed, up-front development of a complete, trial-ready research protocol so that the eventual Phase III trial application is stronger, more feasible, and better positioned for rigorous peer review.
This program is specifically focused on Phase III Definitive Clinical Trials (DCTs), meaning large-scale studies that are designed to provide clear, practice-changing evidence about an intervention. A key feature of the R34 planning grant is that it allows reviewers to evaluate the trial concept early, including whether the scientific rationale is solid, whether the overall design is appropriate, and whether the organizational and operational plans are realistic for a multi-site effort. In other words, the grant is meant to reduce avoidable failures later by requiring applicants to resolve the major design and implementation issues before they ask for full Phase III funding.
A major deliverable supported by this FOA is the creation of a detailed Manual of Procedures (MOP). The MOP is essentially the operational blueprint for the future Phase III trial and is required for submission with an application to the NIDCD Phase III Definitive Clinical Trial mechanism (referenced as PAR 08 205 in the announcement). The planning grant funds the practical work required to make that manual truly usable across multiple sites, rather than a high-level concept document. This includes specifying how participants will be recruited and retained, how eligibility and outcomes will be measured, how the intervention will be delivered consistently, how protocol deviations will be handled, and how staff across sites will be trained to follow the same procedures.
Beyond drafting the protocol and MOP, the R34 is also meant to help applicants assemble and organize the trial infrastructure. That can include establishing the research team and governance structure, clarifying roles and responsibilities across participating centers, and setting up systems for study oversight. It also supports development of tools and processes for data management, quality control, and monitoring, which are especially critical in multi-center trials where consistency and data integrity can make or break the study.
This FOA is not intended to support early-stage or smaller clinical trials. It explicitly excludes Phase I/II preliminary clinical trials, directing those projects instead to a separate NIDCD funding announcement (PAR 08 204) for Phase I/II Preliminary Clinical Trials in Communication Disorders. In practical terms, applicants should use PAR 08 203 when they already have enough preliminary evidence to justify a definitive Phase III question, but need support to fully engineer the trial so it can be implemented at scale.
The mechanism of support is the NIH Clinical Trial Planning Grant (R34). The NIH notes that award size, project duration, total dollars awarded, and the number of awards are not fixed and will vary depending on the scope and cost of the planning work proposed, as well as the number and quality of applications received.
Eligibility is broad and includes many organization types across the public, private, and nonprofit sectors. Eligible applicants include for-profit organizations (including small businesses), nonprofit organizations with or without 501(c)(3) status, private and public institutions of higher education, state and local governments (including counties, cities, townships, and special district governments), independent school districts, public housing authorities/Indian housing authorities, and tribal governments (both federally recognized and other tribal organizations). The eligibility list also explicitly includes organizations 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, regional organizations, eligible federal agencies, and U.S. territories or possessions. There is no cost sharing or matching requirement.
Key administrative details from the listing include the posted date (July 16, 2008), the creation date (April 6, 2009), and the timeline information indicating original and current closing dates that reflect the historical status of this specific announcement (with an archive date of June 7, 2009). The sponsoring agency is NIH, and the full announcement was made available through the NIH grants portal at the link provided in the source text. Contact support for technical access and linking issues is directed to the NIH Office of Extramural Research (OER) webmaster.
FAQs: NIDCD Clinical Trial Planning Grant (R34) - PAR 08 203
What is the NIDCD Clinical Trial Planning Grant (R34) under PAR 08 203?
PAR 08 203 is a National Institutes of Health (NIH) funding opportunity from the National Institute on Deafness and Other Communication Disorders (NIDCD) that supports planning activities needed before launching a large, multicenter Phase III Definitive Clinical Trial in areas related to deafness and communication disorders (CFDA 93.173).
What is the main purpose of this grant?
The main purpose is to fund the up-front work required to develop a complete, trial-ready Phase III protocol and supporting operational materials so a future Phase III trial application is stronger, more feasible, and better positioned for rigorous peer review.
Does this grant pay for running the full Phase III clinical trial?
No. The central aim is not to fund execution of the full Phase III trial. It is intended to support planning and preparation so the eventual Phase III trial can be proposed and conducted more effectively.
What kinds of clinical trials are the focus of this FOA?
This FOA is specifically focused on Phase III Definitive Clinical Trials (DCTs), described as large-scale studies designed to provide clear, practice-changing evidence about an intervention.
Why does NIH/NIDCD offer a planning grant for Phase III trials?
The planning grant is designed so reviewers can evaluate the trial concept early (scientific rationale, design appropriateness, and operational realism) and so applicants can resolve major design and implementation issues before seeking full Phase III funding, reducing avoidable failures later.
What is a key required deliverable of the R34 planning grant?
A major deliverable is a detailed Manual of Procedures (MOP), which serves as the operational blueprint for the future multicenter Phase III trial.
What is the Manual of Procedures (MOP) used for?
The MOP is required for submission with an application to the NIDCD Phase III Definitive Clinical Trial mechanism referenced in the announcement as PAR 08 205. It is meant to be an actionable, site-ready operational guide rather than a high-level concept document.
What kinds of details should the MOP cover for a multicenter trial?
Based on the announcement description, the MOP should specify items such as participant recruitment and retention procedures, eligibility and outcome measurement methods, how the intervention will be delivered consistently across sites, how protocol deviations will be handled, and how staff across sites will be trained to follow standardized procedures.
Besides the protocol and MOP, what planning activities can the R34 support?
The R34 can support assembling and organizing trial infrastructure, including establishing the research team and governance structure, clarifying roles and responsibilities across centers, and creating systems and processes for study oversight.
Does the planning grant support data-related and quality-related planning work?
Yes. It supports development of tools and processes for data management, quality control, and monitoring, which are especially important for maintaining consistency and data integrity across multiple sites.
Is this FOA intended for early-stage clinical trials (Phase I or Phase II)?
No. The FOA explicitly excludes Phase I/II preliminary clinical trials and directs those projects to a separate NIDCD funding announcement (PAR 08 204) for Phase I/II Preliminary Clinical Trials in Communication Disorders.
When should an applicant use PAR 08 203 instead of the Phase I/II FOA?
PAR 08 203 is intended for situations where there is already enough preliminary evidence to justify a definitive Phase III question, but additional support is needed to fully engineer the trial so it can be implemented at scale as a multicenter Phase III effort.
What is the funding mechanism for this opportunity?
The mechanism of support is the NIH Clinical Trial Planning Grant (R34).
Are award size, project duration, and number of awards fixed?
No. NIH notes that award size, project duration, total dollars awarded, and the number of awards are not fixed. They vary depending on the scope and cost of the proposed planning work, and on the number and quality of applications received.
Is there a cost sharing or matching requirement?
No. The listing states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is broad and includes many organization types across public, private, and nonprofit sectors. The listing includes for-profit organizations (including small businesses), nonprofit organizations (with or without 501(c)(3) status), private and public institutions of higher education, and multiple government entities and other eligible organizations.
Are state and local government entities eligible?
Yes. The eligibility list includes state and local governments, including counties, cities, townships, and special district governments.
Are tribal governments and tribal organizations eligible?
Yes. The eligibility list includes tribal governments (federally recognized) as well as other tribal organizations.
Are schools and housing authorities eligible?
Yes. The eligibility list includes independent school districts and 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), and Alaska Native and Native Hawaiian Serving Institutions.
Are faith-based, community-based, and regional organizations eligible?
Yes. The eligibility list includes faith-based or community-based organizations and regional organizations.
Are federal agencies eligible to apply?
Yes. The eligibility list includes eligible federal agencies.
Are U.S. territories eligible?
Yes. The eligibility list includes U.S. territories or possessions.
What is the CFDA number associated with this opportunity?
The CFDA number provided is 93.173.
What are the key dates listed for this opportunity?
The listing includes a posted date of July 16, 2008 and a creation date of April 6, 2009. It also notes timeline information indicating original and current closing dates reflecting the historical status of the announcement, with an archive date of June 7, 2009.
Where was the full announcement made available?
The listing indicates the full announcement was made available through the NIH grants portal at the link provided in the source text.
Who should be contacted for technical access or linking issues related to the announcement?
Technical access and linking issues are directed to the NIH Office of Extramural Research (OER) webmaster.
What related Phase III funding mechanism is referenced for the future definitive trial application?
The announcement references submission to the NIDCD Phase III Definitive Clinical Trial mechanism, identified as PAR 08 205.
What related Phase I/II funding mechanism is referenced for preliminary trials?
The announcement references a separate funding opportunity for Phase I/II Preliminary Clinical Trials in Communication Disorders, identified as PAR 08 204.
What does "trial-ready" mean in the context of this planning grant?
In the context described, it means producing a complete and detailed research protocol and operational documentation (including a usable MOP) and organizing practical multicenter infrastructure (oversight, roles, data systems, quality control, monitoring, and training plans) so the study can be implemented consistently across multiple sites.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 08 203) also looked into and applied for these:
| Funding Opportunity |
|---|
| NIDCD Phase I/II Preliminary Clinical Trials in Communication Disorders (R01) Apply for PAR 08 204 Funding Number: PAR 08 204 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIDCD Phase III Definitive Clinical Trials in Communication Disorders (R01) Apply for PAR 08 205 Funding Number: PAR 08 205 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Deep Sequencing and Haplotype Profiling of Mental Disorders (R01) Apply for PA 08 198 Funding Number: PA 08 198 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Addressing the Mental Health Needs of Returning Combat Veterans in the Community (R01) Apply for RFA MH 09 070 Funding Number: RFA MH 09 070 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Deep Sequencing and Haplotype Profiling of Mental Disorders (Collaborative R01) Apply for PAR 08 199 Funding Number: PAR 08 199 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Exploratory/Developmental Projects in Translational Research for Neuromuscular Disease (R21) Apply for PAR 08 228 Funding Number: PAR 08 228 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Translational Research at the Aging/Cancer Interface (TRACI) (R01) Apply for PA 08 230 Funding Number: PA 08 230 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Translational Research at the Aging/Cancer Interface (TRACI) (R21) Apply for PA 08 231 Funding Number: PA 08 231 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| NINDS Exploratory/Developmental Projects in Translational Research (R21) Apply for PAR 08 232 Funding Number: PAR 08 232 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Aging Research Dissertation Awards to Increase Diversity (R36) Apply for PAR 08 250 Funding Number: PAR 08 250 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Archiving and Development of Socialbehavioral Datasets in Aging Related Studies (R03) Apply for PA 08 252 Funding Number: PA 08 252 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Functioning of People with Mental Disorders (R01) Apply for PA 08 255 Funding Number: PA 08 255 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| The Effects of Alcohol on Glial Cells (R01) Apply for RFA AA 09 003 Funding Number: RFA AA 09 003 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| The Effects of Alcohol on Glial Cells (R21) Apply for RFA AA 09 004 Funding Number: RFA AA 09 004 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Follow up Public Consultation to Inform the Design of a Possible Longitudinal Cohort Study of the Role of Genes and Environment in Health and Disease Limited Competition (U01) Apply for RFA HG 09 004 Funding Number: RFA HG 09 004 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| National Institute of Mental Health (NIMH) Career Opportunities in Research (COR) Honors Undergraduate Research Training Grant (T34) Apply for PAR 08 093 Funding Number: PAR 08 093 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Researching Implementation and Change while Improving Quality (R18) Apply for PAR 08 136 Funding Number: PAR 08 136 Agency: Agency for Health Care Research and Quality Category: Health Funding Amount: Case Dependent |
| NEI CAREER TRANSITION AWARD (K22) Apply for PAR 04 136 Funding Number: PAR 04 136 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Career Development Award to Promote Diversity in Neuroscience Research Apply for PAR 05 071 Funding Number: PAR 05 071 Agency: National Institutes of Health Category: Health Funding Amount: $50,000 |
| AHRQ Mentored Clinical Scientist Development Award (K08) Apply for PAR 07 443 Funding Number: PAR 07 443 Agency: Agency for Health Care Research and Quality Category: Health Funding Amount: Case Dependent |
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