Opportunity Information: Apply for PAR 15 059
Apply for PAR 15 059
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCR Clinical Trial or Biomarker Clinical Validation Study 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 Dec 8, 2014 and posted on Dec 8, 2014.
- Applicants must submit their applications by Jan 7, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Special district governments Independent school districts Public housing authorities/Indian housing authorities State governments Public and State controlled institutions of higher education For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Small businesses Native American tribal governments (Federally recognized) County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education 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) Private 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 Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIDCR Clinical Trial or Biomarker Clinical Validation Study Cooperative Agreement (U01) (Funding Opportunity Number PAR-15-059) is a National Institutes of Health (NIH) funding opportunity from the National Institute of Dental and Craniofacial Research (NIDCR) aimed at supporting investigator-initiated, patient-oriented research in dental, oral, and craniofacial health. The main purpose of the announcement is to fund well-defined clinical studies that require prospective collection of clinical outcomes and, when relevant, the collection of clinical specimens. This includes traditional interventional clinical trials as well as biomarker-focused studies where clinical validation depends on collecting outcomes in a forward-looking study design rather than relying only on existing samples or retrospective data.
The scope of supported research is broad in terms of trial phase and study type. NIDCR indicates it will support Phase I, II, III, or IV clinical trials, meaning projects may range from early safety and feasibility work through larger efficacy/effectiveness trials and post-marketing or post-implementation studies. In addition, the FOA explicitly includes "stage 1-4 behavioral or social intervention trials," signaling that NIDCR is also interested in interventions that are not purely biomedical (for example, behavior change programs, adherence interventions, community-based strategies, or health services approaches) as long as they follow a clinical trial framework. Another major emphasis is biomarker clinical validation studies, which generally focus on determining whether a biomarker meaningfully predicts, correlates with, or can serve as a surrogate for clinically relevant outcomes in real-world or trial settings, using prospectively collected outcomes and specimens to establish performance and relevance.
This opportunity uses the cooperative agreement mechanism (U01), which is distinct from a standard research project grant because it anticipates substantial scientific or programmatic involvement from NIH staff during the project. In practical terms, applicants should expect a more collaborative relationship with NIDCR compared with typical investigator-initiated grants, including coordination on study milestones, oversight expectations, and potentially harmonization with institute priorities or broader clinical research standards. The funding instrument type is listed as a Cooperative Agreement, and the activity category is Health. The Catalog of Federal Domestic Assistance (CFDA) listing associated with the announcement is 93.121, Oral Diseases and Disorders Research. Cost sharing or matching is not required.
Eligibility is intentionally wide. The FOA allows applications from many categories of U.S. organizations, including state, county, and local governments; public housing authorities; school districts; public and private institutions of higher education; and a range of nonprofit and for-profit organizations (including small businesses). It also recognizes eligibility for organizations that serve specific populations and institutional types, such as Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Tribally Controlled Colleges and Universities, and Alaska Native and Native Hawaiian Serving Institutions, among others. Importantly, the announcement permits non-U.S. entities and foreign institutions to apply, and it allows foreign components of U.S. organizations as defined under NIH policy. Faith-based and community-based organizations and eligible federal agencies are also included among the eligible applicants, reflecting NIH's interest in enabling a wide range of capable organizations to conduct high-quality clinical trials and validation studies.
From an administrative timeline perspective, the opportunity was posted and created on December 8, 2014, with an original and current closing date of January 7, 2018, and an archive date of February 7, 2018. That means this specific FOA is no longer open for new applications under the archived announcement, but it remains a useful reference point for understanding the type of clinical trial and biomarker validation work NIDCR sought to support through a U01 mechanism during that period.
For those seeking the official, complete announcement text and requirements, the FOA points to the NIH Grants Guide link at http://grants.nih.gov/grants/guide/pa-files/PAR-15-059.html. The provided contact for technical issues accessing or linking to the announcement is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
FAQs: NIDCR Clinical Trial or Biomarker Clinical Validation Study Cooperative Agreement (U01) (PAR-15-059)
What is this funding opportunity?
This opportunity is the NIDCR Clinical Trial or Biomarker Clinical Validation Study Cooperative Agreement (U01), Funding Opportunity Number PAR-15-059. It is an NIH funding opportunity from the National Institute of Dental and Craniofacial Research (NIDCR) focused on supporting investigator-initiated, patient-oriented research in dental, oral, and craniofacial health.
What is the main purpose of PAR-15-059?
The main purpose is to fund well-defined clinical studies that require prospective collection of clinical outcomes and, when relevant, the collection of clinical specimens. The announcement covers traditional interventional clinical trials as well as biomarker-focused studies where clinical validation depends on forward-looking (prospective) study designs rather than relying only on existing samples or retrospective data.
What kinds of studies does NIDCR intend to support under this FOA?
NIDCR indicates support for clinical studies involving prospective outcome collection, including interventional clinical trials and biomarker clinical validation studies. The scope is broad in terms of study type and trial phase, as long as the work aligns with dental, oral, and craniofacial health and uses a prospective framework for outcomes (and specimens when relevant).
Are clinical trials included, and if so, what phases are supported?
Yes. NIDCR indicates it will support Phase I, II, III, or IV clinical trials. This includes projects ranging from early safety and feasibility studies through larger efficacy/effectiveness trials, as well as post-marketing or post-implementation studies.
Does the FOA include behavioral or social intervention trials?
Yes. The FOA explicitly includes stage 1-4 behavioral or social intervention trials, indicating interest in interventions that are not purely biomedical (for example, behavior change programs, adherence interventions, community-based strategies, or health services approaches), as long as they follow a clinical trial framework.
What is meant by a biomarker clinical validation study in this opportunity?
Biomarker clinical validation studies are a major emphasis of the FOA. These studies generally focus on determining whether a biomarker meaningfully predicts, correlates with, or can serve as a surrogate for clinically relevant outcomes. Under this announcement, the validation is expected to rely on prospectively collected outcomes and specimens to establish biomarker performance and relevance.
What funding mechanism is used (U01), and why does it matter?
This opportunity uses a cooperative agreement mechanism (U01). Unlike a standard research project grant, a U01 anticipates substantial scientific or programmatic involvement from NIH staff during the project. Applicants should expect a more collaborative relationship with NIDCR, including coordination on study milestones, oversight expectations, and potentially harmonization with institute priorities or broader clinical research standards.
What is the funding instrument type and activity category?
The funding instrument type is a Cooperative Agreement, and the activity category is Health.
What CFDA program is associated with this FOA?
The CFDA listing associated with this announcement is 93.121, Oral Diseases and Disorders Research.
Is cost sharing or matching required?
No. Cost sharing or matching is not required.
Who is eligible to apply?
Eligibility is broad. The FOA allows applications from many categories of U.S. organizations, including state, county, and local governments; public housing authorities; school districts; public and private institutions of higher education; and a range of nonprofit and for-profit organizations (including small businesses). Faith-based and community-based organizations and eligible federal agencies are also included.
Are minority-serving institutions specifically recognized as eligible?
Yes. The announcement recognizes eligibility for organizations serving specific populations and institutional types, including Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Tribally Controlled Colleges and Universities, and Alaska Native and Native Hawaiian Serving Institutions, among others.
Can non-U.S. (foreign) organizations apply?
Yes. The announcement permits non-U.S. entities and foreign institutions to apply, and it allows foreign components of U.S. organizations as defined under NIH policy.
When was this opportunity posted, and is it still open?
The opportunity was posted and created on December 8, 2014. The original and current closing date was January 7, 2018, and the archive date was February 7, 2018. Based on these dates, this specific FOA is no longer open for new applications under the archived announcement.
Where can applicants find the official FOA text and full requirements?
The FOA points to the NIH Grants Guide page at: http://grants.nih.gov/grants/guide/pa-files/PAR-15-059.html.
Who should be contacted for technical issues accessing or linking to the announcement?
For technical issues accessing or linking to the announcement, the provided contact is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
What kinds of data collection does this FOA emphasize?
The FOA emphasizes prospective collection of clinical outcomes and, when relevant, collection of clinical specimens. This prospective approach is central both for traditional clinical trials and for biomarker clinical validation studies described in the opportunity.
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