NIDCR Clinical Trial Implementation or Biomarker Clinical Evaluation Study Cooperative Agreement (U01) | Apply Online

Frequently Asked Questions (FAQs)

What is PAR-11-339?

PAR-11-339 is the Funding Opportunity Announcement (FOA) number for the NIDCR Clinical Trial Implementation or Biomarker Clinical Evaluation Study Cooperative Agreement (U01). It was a National Institutes of Health (NIH) opportunity issued by the National Institute of Dental and Craniofacial Research (NIDCR) to support investigator-initiated clinical research in oral and craniofacial health.

Which NIH institute offered this opportunity?

This FOA was offered by the National Institute of Dental and Craniofacial Research (NIDCR), part of NIH.

What kinds of studies were intended to be funded?

The announcement was designed to support the actual conduct (implementation) of Phase I, II, III, or IV clinical trials, as well as biomarker clinical evaluation studies, as long as the work required prospective collection of clinical outcomes and the collection of clinical specimens.

Does this FOA support planning, or only trial implementation?

This mechanism targeted studies that were ready to move beyond planning and into real-world implementation. It focused on the operational and regulatory demands of conducting the study (for example, enrolling participants, collecting data over time, and handling biospecimens under controlled conditions), rather than early concept development.

What does NIDCR mean by “biomarker clinical evaluation study” in this context?

Based on the FOA description, biomarker clinical evaluation studies under this opportunity were expected to involve prospective collection of clinical outcomes and collection of clinical specimens, indicating a clinical evaluation setting with real participant follow-up and biospecimen handling.

Was an NIDCR Clinical Trial Planning Grant (R34) required before applying?

Generally, yes. A central requirement was that applicants generally needed to have already completed an NIDCR Clinical Trial Planning Grant (R34) specifically intended to prepare the proposed U01 study (referenced as PAR-11-338). NIDCR noted it could consider exceptions, but the default expectation was that the R34 planning work had already been completed for the proposed U01.

Why did the FOA emphasize completing an R34 first?

The structure was intended to ensure the U01 application represented a mature, implementation-ready project rather than a concept still being developed. The expectation was that feasibility considerations, protocol development, and key operational decisions would have been finalized during the R34 stage.

Can one application cover multiple trials or multiple unrelated studies?

No. The FOA emphasized that each application had to be tied to a single, specific study. Applicants could not bundle multiple unrelated trials under one proposal.

What key documents were expected to be included with the application?

The application needed to include a final draft clinical protocol and a Manual of Procedures, along with other supporting documents commonly required for clinical trial readiness, such as an Investigator's Brochure when applicable.

What is a “Manual of Procedures,” and why was it required?

The FOA required a Manual of Procedures as part of clinical trial readiness materials. In practical terms, it supports consistent site operations and quality control by documenting operational processes the study will follow.

Were there specific compliance expectations for human subjects and regulation?

Yes. The FOA indicated that application materials were expected to meet NIH standards and align with U.S. regulatory and human subjects protection requirements, including relevant Food and Drug Administration (FDA) expectations and Office of Human Research Protections (OHRP) requirements.

What type of award mechanism was used?

Awards were made as cooperative agreements (U01).

How is a U01 cooperative agreement different from a standard research grant?

Under a cooperative agreement, investigators still lead the science, but NIH typically has substantial programmatic involvement. The FOA described closer collaboration with NIDCR staff on elements such as study milestones, performance monitoring, data and safety oversight expectations, and coordination around operational challenges.

Why use a cooperative agreement for clinical trials?

The FOA described the cooperative agreement format as commonly used for clinical trials because it supports active stewardship of participant safety, data integrity, recruitment progress, and protocol adherence, including in complex or multi-site environments.

Who was eligible to apply?

Eligibility was broad. Eligible applicants included various levels of government (state, county, city or township), special district governments, public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including entities other than small businesses), small businesses, independent school districts, public housing authorities/Indian housing authorities, and tribal governments and tribal organizations.

Did the eligibility language explicitly include specific institution types (for example, HBCUs or Hispanic-serving institutions)?

Yes. The FOA explicitly included institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities, and faith-based or community-based organizations.

Were foreign institutions allowed to apply?

Yes. Foreign institutions and non-U.S. components of U.S. organizations were allowed to apply, and foreign components (as defined by NIH policy) were permitted, enabling international collaboration where scientifically justified.

What was the CFDA number for this opportunity?

The FOA was aligned with CFDA 93.121, Oral Diseases and Disorders Research.

Was cost sharing or matching required?

No. The FOA stated it did not require cost sharing or matching.

What was the funding category and administrative classification?

Administratively, it was described as a discretionary funding opportunity within the health category.

When was the opportunity posted, and is it still open?

The opportunity was posted and created on September 16, 2011. The original and final closing date listed was January 7, 2015, with an archive date of February 7, 2015. This means it is no longer active for new submissions under that particular announcement.

Where was the full announcement posted?

The full announcement historically lived on the NIH Grants Guide website at the link provided in the notice.

Who should be contacted for technical issues accessing the announcement?

For technical issues accessing the announcement, NIH directed applicants to the NIH Office of Extramural Research webmaster contact.