Opportunity Information: Apply for PAR 08 196
Apply for PAR 08 196
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCR Clinical Trial Implementation Cooperative Agreement (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121 Oral Diseases and Disorders Research.
- This funding opportunity was created on Feb 25, 2011 and posted on Dec 3, 2008.
- Applicants must submit their applications by May 7, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) 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) City or township governments For profit organizations other than small businesses Public and State controlled institutions of higher education Independent school districts Small businesses County governments Private institutions of higher education Special district governments State 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) 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 NIDCR Clinical Trial Implementation Cooperative Agreement (U01) opportunity (Funding Opportunity Number PAR-08-196) is a National Institutes of Health program run by the National Institute of Dental and Craniofacial Research (NIDCR) to fund the actual conduct and execution of investigator-initiated clinical trials in oral, dental, and craniofacial health. It is designed specifically as an implementation mechanism, meaning it supports the launch and operational rollout of a trial that has already been carefully planned and documented. Trials can be Phase I, II, III, or IV, and awards are issued as cooperative agreements (U01), which typically means NIDCR staff will have substantial scientific and programmatic involvement during the life of the study compared with a standard research project grant.
A key restriction is that applications are intended only for investigators who previously received an NIDCR Clinical Trial Planning Grant (R34) under the related planning announcement (PAR-08-195), unless NIDCR grants an exception. In other words, this U01 is meant to be the next step after an R34 planning period: applicants are expected to have already completed the major planning tasks and to be ready to implement a well-developed protocol. The application must be submitted using the PHS 398 application package with special instructions, and it must include the major deliverables that come out of the R34 planning process. Those required attachments include a final draft clinical trial protocol, a Clinical Investigator's Brochure (or an equivalent document if an Investigator's Brochure is not applicable), and a Manual of Procedures. NIDCR also emphasizes that these documents must satisfy all applicable requirements from NIH as well as federal human subjects and regulatory bodies, specifically the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP). That signals that reviewers and program staff will be looking for operational readiness and compliance infrastructure, not just scientific ideas.
From a funding and award structure standpoint, the announcement does not set a single fixed budget or project length because the expected costs and timelines for clinical trials can vary widely. Instead, NIDCR indicates that the size, duration, and number of awards will depend on factors such as how closely the proposed trial aligns with the NIDCR mission and strategic plan, the complexity of the trial design and operations, how long the trial is expected to run, and the operational costs proposed to carry it out (for example, site management, coordinating center functions, recruitment and retention activities, data management, safety monitoring, and related infrastructure). The activity category is health, and the relevant CFDA listing is 93.121 (Oral Diseases and Disorders Research). There is no cost sharing or matching requirement.
Eligibility is broad and includes many common applicant types that apply for NIH funding, spanning nonprofit and for-profit organizations (including small businesses), public and private institutions of higher education, state and local governments, tribal governments and tribal organizations, public housing authorities, independent school districts, special district governments, and certain regional organizations. The notice also explicitly includes several categories often highlighted in federal eligibility language, 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, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). While the eligibility list is expansive, the practical gateway requirement remains the R34 planning award (unless an exception is granted), which effectively narrows the pool to teams that have already gone through NIDCR-supported clinical trial planning.
Administratively, the opportunity was posted December 3, 2008, with an original closing date of September 7, 2011, a current closing date listed as May 7, 2011, and an archive date of June 7, 2011, indicating it is no longer active as a current open solicitation in its original form. The full announcement was available through the NIH Grants Guide page, and NIH Office of Extramural Research (OER) webmaster contacts were provided for access and linking issues. Overall, the core idea of this FOA is to move well-prepared, R34-planned NIDCR clinical trials into the funded implementation stage under a cooperative agreement structure that supports close coordination with the Institute and strong emphasis on regulatory-compliant trial operations.
FAQs: NIDCR Clinical Trial Implementation Cooperative Agreement (U01) - PAR-08-196
What is PAR-08-196?
PAR-08-196 is the NIDCR Clinical Trial Implementation Cooperative Agreement (U01) funding opportunity from the National Institutes of Health (NIH), run by the National Institute of Dental and Craniofacial Research (NIDCR). It supports the actual conduct and execution of investigator-initiated clinical trials in oral, dental, and craniofacial health.
What is the main purpose of this U01 opportunity?
This opportunity is designed as an implementation mechanism. It is meant to fund the launch and operational rollout of a clinical trial that has already been carefully planned and documented, rather than funding early-stage concept development.
What types of clinical trials can be supported?
The FOA allows clinical trials in Phase I, II, III, or IV, as long as they fall within oral, dental, and craniofacial health and are ready for implementation.
What does it mean that this is a cooperative agreement (U01)?
A U01 is a cooperative agreement, which generally means NIDCR staff will have substantial scientific and programmatic involvement during the life of the study compared with a standard NIH research project grant. This structure supports close coordination with the Institute while the trial is being carried out.
Who is the intended applicant pool for PAR-08-196?
Applications are intended only for investigators who previously received an NIDCR Clinical Trial Planning Grant (R34) under the related planning announcement (PAR-08-195), unless NIDCR grants an exception. In practice, this makes the U01 a next-step award following an R34-funded planning period.
Is an NIDCR R34 planning grant required before applying?
Yes. The FOA states that applications are intended only for investigators who previously received an NIDCR Clinical Trial Planning Grant (R34) under PAR-08-195, unless an exception is granted by NIDCR.
Can an investigator apply without having the prior R34 if they request an exception?
The FOA indicates exceptions may be granted by NIDCR. The opportunity description does not provide details on how exceptions are requested or evaluated, only that the default expectation is prior R34 support.
What stage of readiness does NIDCR expect for a U01 implementation application?
NIDCR expects applicants to have completed major planning tasks and to be ready to implement a well-developed protocol. Review and oversight focus heavily on operational readiness and compliance infrastructure, not just the scientific idea.
What application format/package must be used?
The application must be submitted using the PHS 398 application package, following special instructions referenced by the FOA.
What key attachments or deliverables must be included from the R34 planning process?
The FOA requires inclusion of major R34 planning deliverables as attachments. Specifically, it calls for a final draft clinical trial protocol, a Clinical Investigator's Brochure (or an equivalent document if an Investigator's Brochure is not applicable), and a Manual of Procedures.
Is a Clinical Investigator's Brochure always required?
The FOA requires a Clinical Investigator's Brochure or an equivalent document if an Investigator's Brochure is not applicable, indicating alternatives are acceptable when a traditional brochure does not fit the study context.
What is the Manual of Procedures and why is it required?
The FOA requires a Manual of Procedures as part of demonstrating implementation readiness. Based on the way NIDCR describes its expectations, this document serves as operational guidance for how the trial will be conducted and managed in practice.
What regulatory and compliance standards must these documents meet?
NIDCR emphasizes that the protocol, brochure (or equivalent), and manual must satisfy applicable requirements from NIH and from federal human subjects and regulatory bodies, specifically the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP).
Does this FOA emphasize operational compliance or scientific concept development?
Operational compliance and execution readiness are central. The U01 is positioned as the implementation phase after planning, and NIDCR signals that reviewers and program staff will look for regulatory-compliant trial operations and supporting infrastructure.
Does PAR-08-196 set a fixed budget cap or fixed project period?
No. The announcement does not set a single fixed budget or project length because clinical trial costs and timelines can vary widely.
What determines the size, duration, and number of awards?
NIDCR states these will depend on factors including alignment with the NIDCR mission and strategic plan, the complexity of the trial design and operations, the expected trial duration, and the operational costs needed to conduct the study.
What types of costs are implied as part of trial operations in this FOA?
The FOA references operational costs such as site management, coordinating center functions, recruitment and retention activities, data management, safety monitoring, and related infrastructure needed to run the trial.
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
What is the CFDA listing for this program?
The relevant CFDA listing is 93.121, titled Oral Diseases and Disorders Research.
What is the activity category?
The activity category is health.
What organizations are eligible to apply?
Eligibility is broad and includes nonprofit and for-profit organizations (including small businesses), public and private institutions of higher education, state and local governments, tribal governments and tribal organizations, public housing authorities, independent school districts, special district governments, and certain regional organizations.
Are minority-serving institutions and community-based organizations included in eligibility?
Yes. The FOA explicitly includes categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations.
Are applicants from U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly included in the eligibility language described.
Are foreign (non-U.S.) organizations eligible?
Yes. The eligibility list explicitly includes non-U.S. entities (foreign organizations).
If eligibility is broad, what is the practical gatekeeper requirement?
Even though many organization types are eligible in principle, the FOA is intended only for investigators who previously received the NIDCR R34 Clinical Trial Planning Grant under PAR-08-195 (unless NIDCR grants an exception). That planning award requirement effectively narrows the pool to teams that already completed NIDCR-supported clinical trial planning.
When was this funding opportunity posted, and is it still active?
The opportunity was posted on December 3, 2008. It lists an original closing date of September 7, 2011, a current closing date of May 7, 2011, and an archive date of June 7, 2011, indicating it is no longer active as an open solicitation in its original form.
Where was the full announcement hosted?
The full announcement was available through the NIH Grants Guide page, and NIH Office of Extramural Research (OER) webmaster contacts were provided for access and linking issues.
What is the relationship between PAR-08-195 and PAR-08-196?
PAR-08-195 is the related NIDCR clinical trial planning announcement (R34), and PAR-08-196 is positioned as the next step to fund implementation (U01) after the planning period is complete and the required deliverables are ready.
What is the overall goal of PAR-08-196 in one sentence?
The FOA is intended to move well-prepared, R34-planned NIDCR clinical trials into the funded implementation stage under a cooperative agreement structure with close NIDCR coordination and strong emphasis on regulatory-compliant trial operations.
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