Opportunity Information: Apply for PAR 18 788
The National Institutes of Health (NIH) funding opportunity titled "Precision Imaging of Oral Lesions (R21-Clinical Trial Not Allowed)" (Funding Opportunity Number PAR 18 788) is a discretionary grant program designed to push forward better imaging tools for diseases and conditions affecting the oral cavity and the oropharynx. In practical terms, the FOA is focused on improving how clinicians and researchers detect, characterize, and follow oral lesions by supporting early-stage, exploratory projects that develop or refine imaging methods that can deliver more reliable and clinically meaningful information than what is currently available.
The core purpose of the opportunity is to advance imaging approaches that are accurate, reproducible, specific, and sensitive. That combination matters because imaging in the mouth and throat is often challenged by small anatomic structures, variable lighting and access, motion, saliva, inflammation, and the fact that benign and malignant changes can look similar. By emphasizing accuracy and sensitivity, NIH is signaling interest in methods that can detect true disease and meaningful changes early. By emphasizing specificity, they are also highlighting the need to reduce false positives that can lead to unnecessary biopsies, overtreatment, anxiety, and added cost. Reproducibility is equally important because an imaging approach that only performs well in one lab, one clinic, or with one operator has limited real-world value. Altogether, the program is aiming for imaging methods that can be trusted across sites and settings and that can improve decisions about diagnosis, treatment selection, and treatment monitoring.
Because this is an R21 mechanism, the intent is typically to support novel, high-impact, proof-of-concept work rather than large, definitive validation programs. The FOA explicitly states "Clinical Trial Not Allowed," which means applicants should not propose studies that meet NIH's definition of a clinical trial, such as prospective studies where participants are assigned to an intervention to evaluate effects on health-related outcomes. Projects can still involve human specimens, existing data, or observational and technical validation work, but they must be structured to remain outside the clinical trial definition. This aligns with the FOA's emphasis on development, adaptation, optimization, and validation of imaging approaches at a stage where the key goal is demonstrating technical performance and clinical relevance without running interventional trials.
The opportunity is categorized under health research (CFDA 93.121) and uses the grant funding instrument. The award ceiling listed is $200,000, indicating the maximum amount available per award under the program parameters described in the source data. While the "ExpectedAwards" field is not populated in the provided listing, the program is positioned as a competitive NIH research grant, meaning the number of awards can vary based on application quality, program priorities, and available funds.
Eligibility is broad and includes many common applicant types such as 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; and a wide range of nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding higher education institutions in those categories). It also allows for-profit organizations (other than small businesses) and small businesses, along with public housing authorities and Indian housing authorities. The FOA also explicitly highlights additional eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); and tribal governments that are not federally recognized. It further includes eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Notably, the opportunity is also open to non-domestic (non-U.S.) entities (foreign organizations), which can be important for teams with specialized imaging expertise, unique patient populations, or distinctive technical capabilities outside the United States.
Key administrative details from the source indicate the FOA was created on 2018-05-16 and lists an original closing date of 2021-09-07. The sponsoring agency is NIH. Taken together, this program is essentially a call for innovative imaging science aimed at oral and oropharyngeal lesions, with an emphasis on methods that can meaningfully improve clinical decision-making by making detection and monitoring more precise, while keeping projects in a pre-clinical-trial space appropriate for the R21 exploratory research stage.Apply for PAR 18 788
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Precision Imaging of Oral Lesions (R21-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 2018-05-16.
- Applicants must submit their applications by 2021-09-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $200,000.00 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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Frequently Asked Questions (FAQs): Precision Imaging of Oral Lesions (R21-Clinical Trial Not Allowed)
What is this NIH funding opportunity?
This is a National Institutes of Health (NIH) discretionary grant funding opportunity titled "Precision Imaging of Oral Lesions (R21-Clinical Trial Not Allowed)" (Funding Opportunity Number PAR 18 788). It supports early-stage, exploratory research projects aimed at improving imaging tools for diseases and conditions affecting the oral cavity and the oropharynx.
What is the main goal of the program?
The program is focused on advancing imaging approaches that improve how clinicians and researchers detect, characterize, and follow (monitor over time) oral lesions. The intent is to develop or refine imaging methods that provide more reliable and clinically meaningful information than what is currently available.
What types of conditions or body areas are in scope?
The focus is on diseases and conditions affecting the oral cavity and the oropharynx, with particular emphasis on imaging of oral lesions and related changes in these areas.
What kinds of imaging improvements is NIH looking for?
NIH emphasizes imaging approaches that are accurate, reproducible, specific, and sensitive. In practical terms, the program is interested in imaging methods that can detect disease and meaningful changes early (sensitivity), avoid false positives (specificity), generate correct and clinically useful measurements or classifications (accuracy), and perform consistently across different operators, clinics, or research settings (reproducibility).
Why do accuracy, sensitivity, specificity, and reproducibility matter for oral lesion imaging?
Imaging in the mouth and throat can be difficult due to small anatomical structures, variable lighting and access, motion, saliva, inflammation, and the fact that benign and malignant changes can appear similar. Improving sensitivity can help identify true disease earlier, while improving specificity can reduce false positives that may lead to unnecessary biopsies, overtreatment, anxiety, and added cost. Reproducibility is important so methods are reliable beyond a single lab or clinic.
What does the R21 mechanism imply about the project stage?
An R21 is typically used to support novel, high-impact, proof-of-concept or exploratory research rather than large, definitive validation programs. This FOA aligns with that intent by emphasizing development, adaptation, optimization, and validation activities appropriate for an exploratory stage.
Are clinical trials allowed under this FOA?
No. The FOA explicitly states "Clinical Trial Not Allowed." Applicants should not propose studies that meet NIH's definition of a clinical trial, such as prospective studies in which participants are assigned to an intervention to evaluate effects on health-related outcomes.
If clinical trials are not allowed, can the project still involve humans or human materials?
Yes. Projects may involve human specimens, existing data, observational work, and technical validation work, as long as the study is structured to remain outside NIH's definition of a clinical trial.
What types of activities does the FOA encourage if not clinical trials?
The FOA emphasizes development, adaptation, optimization, and validation of imaging approaches, with the goal of demonstrating technical performance and clinical relevance without running interventional clinical trials.
What is the funding instrument and program type?
This opportunity uses the grant funding instrument and is described as a discretionary grant program.
What is the maximum award amount?
The award ceiling listed in the provided information is $200,000, indicating the maximum amount available per award under the program parameters described.
How many awards will NIH make?
The provided listing does not populate the "ExpectedAwards" field. As a competitive NIH research grant, the number of awards can vary based on application quality, program priorities, and available funds.
What is the CFDA number and what area does it fall under?
The opportunity is categorized under health research with CFDA 93.121.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What organizations are eligible to apply?
Eligibility is broad and includes (as listed in the provided information):
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Nonprofit organizations (501(c)(3) and non-501(c)(3), excluding higher education institutions in those nonprofit categories)
- For-profit organizations (other than small businesses)
- Small businesses
- Public housing authorities and Indian housing authorities
- Federal agencies
- Faith-based or community-based organizations
- Regional organizations
- U.S. territories or possessions
- Tribal governments that are not federally recognized
- Non-domestic (non-U.S.) entities (foreign organizations)
Are minority-serving institutions specifically mentioned as eligible?
Yes. The FOA explicitly highlights eligibility for several categories of institutions, including Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); and Tribally Controlled Colleges and Universities (TCCUs).
Can foreign (non-U.S.) organizations apply?
Yes. The opportunity is open to non-domestic (non-U.S.) entities (foreign organizations), which may be relevant for teams with specialized imaging expertise, unique patient populations, or distinctive technical capabilities outside the United States.
When was this funding opportunity created?
The source information indicates the FOA was created on 2018-05-16.
What is the application closing date listed in the provided information?
The source information lists an original closing date of 2021-09-07.
What is the overall program rationale in plain language?
This program is essentially a call for innovative imaging science aimed at oral and oropharyngeal lesions. It prioritizes imaging methods that can be trusted across sites and settings and that can improve clinical decision-making by making detection and monitoring more precise, while keeping projects in a pre-clinical-trial space appropriate for an R21 exploratory research stage.
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