Opportunity Information: Apply for PAR 27 058
The National Institute of Dental and Craniofacial Research (NIDCR), part of the National Institutes of Health (NIH), is offering funding through a cooperative agreement for investigator-initiated projects focused on either prospective observational studies or biomarker validation studies in dental, oral, and craniofacial health. This opportunity is titled "NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)" and is listed under funding opportunity number PAR-27-058. The key emphasis is on research that either needs prospective (forward-looking) collection of participant data and/or biospecimens, or projects that will continue analyzing data and biospecimens that are being collected prospectively. Despite involving human participants and prospective collection, the funding notice explicitly states that clinical trials are not allowed under this mechanism, meaning applicants should not propose interventional studies where participants are assigned to receive specific treatments or preventive strategies.
The award uses the U01 cooperative agreement mechanism, which generally means the NIH expects to have substantial scientific and/or programmatic involvement during the life of the award compared with a standard research project grant. In practical terms, awardees should anticipate an active partnership with NIDCR staff around study milestones, coordination, oversight, and possibly harmonization of methods or data elements, consistent with how cooperative agreements typically operate. The activity category is health, and the associated CFDA number is 93.121.
This NOFO is broadly open to many types of U.S.-based applicant organizations. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other eligible tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other eligible entities. At the same time, the eligibility rules clearly restrict international participation: non-U.S. (foreign) organizations cannot apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed. In effect, the research and the organizational footprint supported by this award must be fully domestic under NIH definitions.
The opportunity was created on June 16, 2026, and the original closing date is July 5, 2029, indicating a multi-year window in which applications may be accepted according to the NOFOs submission cycles and due dates. The listed award ceiling is $500,000, which signals the maximum budget level expected per award under this announcement (applicants would still need to follow the NOFOs detailed budget instructions and any limitations on direct versus total costs). The posting does not specify the expected number of awards in the provided source text, so applicants would need to consult the full NOFO for more detail on funding availability, award counts, project period limits, and any special requirements.
Overall, this grant is aimed at strengthening the evidence base in dental, oral, and craniofacial research by supporting well-designed, prospective observational efforts and rigorous biomarker validation work, particularly projects where careful, forward-looking data and biospecimen collection is essential. The boundaries are equally important: it is not a clinical trial mechanism, and it is not open to foreign organizations or foreign components, so proposals should be structured as non-interventional observational/validation studies conducted entirely within eligible U.S. organizational and research settings.Apply for PAR 27 058
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121.
- This funding opportunity was created on 2026-06-16.
- Applicants must submit their applications by 2029-07-05.
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed) - PAR-27-058
What is the name of this funding opportunity?
The opportunity is titled "NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)."
What is the funding opportunity number (NOFO number)?
The funding opportunity number is PAR-27-058.
Which NIH institute is offering this grant?
This opportunity is offered by the National Institute of Dental and Craniofacial Research (NIDCR), which is part of the National Institutes of Health (NIH).
What types of projects does this opportunity support?
It supports investigator-initiated projects focused on either (1) prospective observational studies or (2) biomarker validation studies in dental, oral, and craniofacial health.
What does "prospective observational study" mean in this context?
In this context, it refers to research that requires forward-looking (prospective) collection of participant data and/or biospecimens, or continued analysis of data and biospecimens that are being collected prospectively.
Can a project analyze data and biospecimens that are already being collected prospectively?
Yes. The opportunity includes projects that will continue analyzing data and biospecimens that are being collected prospectively.
Are clinical trials allowed under this funding opportunity?
No. The notice explicitly states "Clinical Trial Not Allowed," meaning applicants should not propose interventional studies.
What kinds of studies are considered not allowed under this mechanism?
Interventional studies where participants are assigned to receive specific treatments or preventive strategies are not allowed under this mechanism.
If the study involves human participants and prospective collection, why is it not a clinical trial?
The opportunity can involve human participants and prospective collection of data and/or biospecimens, but it must remain non-interventional (observational/validation) and cannot assign participants to interventions such as treatments or prevention strategies.
What funding mechanism is being used?
The award uses the U01 cooperative agreement mechanism.
What does a U01 cooperative agreement imply for awardees?
A U01 cooperative agreement generally means NIH expects substantial scientific and/or programmatic involvement during the award. In practical terms, awardees should anticipate an active partnership with NIDCR staff related to study milestones, coordination, oversight, and possibly harmonization of methods or data elements, consistent with cooperative agreement operations.
What is the activity category for this opportunity?
The activity category is health.
What is the associated CFDA number?
The associated CFDA number is 93.121.
Who is eligible to apply?
The NOFO is broadly open to many types of U.S.-based applicant organizations, including:
- State, county, city or township governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Federally recognized Native American tribal governments and other eligible tribal organizations
- Public housing authorities/Indian housing authorities
- Nonprofits with or without 501(c)(3) status (other than institutions of higher education)
- For-profit organizations (other than small businesses)
- Small businesses
- Other eligible entities
Are non-U.S. (foreign) organizations eligible to apply?
No. Non-U.S. (foreign) organizations cannot apply under this opportunity.
Are non-U.S. components of U.S. organizations eligible?
No. Non-U.S. components of U.S. organizations are not eligible.
Are foreign components (as defined by NIH policy) allowed?
No. Foreign components (as defined by NIH policy) are not allowed.
What does the international restriction mean for where the work can be done?
Based on the stated eligibility restrictions, the organizational footprint and supported research must be fully domestic under NIH definitions (no foreign organizations, no non-U.S. components of U.S. organizations, and no foreign components).
When was this opportunity created?
The opportunity was created on June 16, 2026.
What is the original closing date?
The original closing date is July 5, 2029.
Does the long open window mean I can apply at any time?
The listing indicates a multi-year window, but applications are accepted according to the NOFO's submission cycles and due dates.
What is the maximum award amount (award ceiling)?
The listed award ceiling is $500,000.
Is the $500,000 limit referring to direct costs or total costs?
The provided information describes $500,000 as the maximum budget level expected per award, but it also notes applicants must follow the NOFO's detailed budget instructions and any limitations on direct versus total costs.
How many awards will be made?
The provided information does not specify the expected number of awards. Applicants would need to consult the full NOFO for details on funding availability and award counts.
Where can applicants find details not included in the summary (for example, project period limits or special requirements)?
The summary indicates that applicants should consult the full NOFO for more detail on funding availability, expected number of awards, project period limits, and any special requirements.
What is the overall purpose of this funding opportunity?
The purpose is to strengthen the evidence base in dental, oral, and craniofacial research by supporting well-designed prospective observational studies and rigorous biomarker validation work, especially where careful forward-looking data and biospecimen collection is essential.
What are the key boundaries applicants should keep in mind?
The key boundaries are that the project must not be a clinical trial (no assignment to interventions) and the application cannot include foreign organizations or foreign components; supported work must be fully domestic under NIH definitions.
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