Opportunity Information: Apply for PA 15 335
Apply for PA 15 335
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Imaging Diagnostics of Dental Diseases and Conditions (Caries, Periodontal Disease, Cracked Teeth, and Pulp Vitality) (R43/R44)" 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 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health.
- This funding opportunity was created on Aug 20, 2015 and posted on Aug 20, 2015.
- Applicants must submit their applications by Sep 7, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
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Opportunity Summary:
The funding opportunity PA 15 335, titled "Imaging Diagnostics of Dental Diseases and Conditions (Caries, Periodontal Disease, Cracked Teeth, and Pulp Vitality) (R43/R44)," is a Small Business Innovation Research (SBIR) grant program from the National Institutes of Health (NIH). Its central goal is to push forward the advanced development and real-world clinical adoption of imaging-based diagnostic devices that can detect and assess common dental diseases and conditions more accurately than the tools most clinicians rely on today. The focus is on four major targets: dental caries, periodontal disease, cracked teeth, and pulp vitality. The program emphasizes that proposed technologies should be reliable and reproducible, and they must achieve very high specificity and sensitivity, meaning they should correctly identify disease when it is present and avoid false alarms when it is not.
A key expectation is that these imaging diagnostics should show clear performance advantages over current standard methods, particularly the usual visual and tactile examination and traditional radiographic approaches used for caries detection. Importantly, better performance cannot come at the cost of increased risk to patients. In practical terms, applicants are being pushed to deliver diagnostics that improve clinical decision-making without adding avoidable harms, such as unnecessary radiation exposure, excessive heat, or other safety concerns that might arise from some energy-based imaging systems.
The announcement highlights a range of technical approaches that applicants may explore. These include optical coherence tomography (OCT), either alone or combined with Raman spectroscopy, as well as MRI image analysis techniques. It also calls out several device and signal-based methods that can be used to infer tissue condition, such as electrical conductivity measurement (ECM), quantitative laser fluorescence (QLF), alternating current impedance spectroscopy, multiphoton imaging, infrared thermography, infrared fluorescence, ultrasound, and terahertz imaging. While these examples illustrate the kinds of platforms NIH considers relevant, the opportunity explicitly welcomes the development of entirely new imaging modalities, signaling that novel physics, new contrast mechanisms, new combinations of modalities, and improved computational interpretation methods are all within scope as long as they address the clinical needs.
Administratively, this is a discretionary grant mechanism under the SBIR R43/R44 pathway, which generally maps to phased small business development (commonly understood as early feasibility and development work followed by more advanced development and steps toward commercialization and implementation). The funding opportunity is associated with CFDA numbers 93.121 (Oral Diseases and Disorders Research) and 93.286 (Discovery and Applied Research for Technological Innovations to Improve Human Health). There is no cost sharing or matching requirement, which matters for small businesses that may not have the ability or desire to commit non-federal dollars as a condition of award.
Eligibility is limited to small businesses. Foreign (non-U.S.) organizations are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, "foreign components" as defined by the NIH Grants Policy Statement may be allowed in some cases, which typically means a U.S.-based applicant might be able to include certain specific foreign activities or collaborations if they are well-justified and compliant with NIH policy.
The opportunity was posted and created on August 20, 2015, with an original and current closing date of September 7, 2018, and an archive date of October 8, 2018, indicating that this specific announcement is no longer open for applications. The official announcement and details were hosted by NIH at the provided link (grants.nih.gov), and NIH’s Office of Extramural Research (OER) webmaster contact was listed for technical access or linking issues.
Frequently Asked Questions (FAQs)
What is PA-15-335?
PA-15-335 is an NIH Small Business Innovation Research (SBIR) funding opportunity titled "Imaging Diagnostics of Dental Diseases and Conditions (Caries, Periodontal Disease, Cracked Teeth, and Pulp Vitality) (R43/R44)." It supports small businesses developing imaging-based diagnostic devices intended to improve detection and assessment of common dental diseases and conditions.
What is the main goal of this SBIR opportunity?
The goal is to advance the development and real-world clinical adoption of imaging diagnostics that can detect and assess dental diseases and conditions more accurately than the tools most clinicians commonly use today. The announcement emphasizes technologies that can improve clinical decision-making through better diagnostic performance.
Which dental diseases and conditions are the focus of this program?
The program focuses on four primary targets: dental caries, periodontal disease, cracked teeth, and pulp vitality.
What kind of diagnostic performance is NIH expecting from proposed technologies?
The announcement stresses that proposed imaging diagnostics should be reliable and reproducible, with very high specificity and sensitivity. In practical terms, NIH is looking for tools that correctly identify disease when it is present (high sensitivity) and avoid false alarms when disease is not present (high specificity).
How should proposed technologies compare to current standard methods?
Proposed diagnostics are expected to show clear performance advantages over current standard methods. The announcement specifically highlights comparison to typical visual and tactile examinations and traditional radiographic approaches used for caries detection.
Can improved performance come with increased risk to patients?
No. The opportunity emphasizes that improved diagnostic performance should not be achieved at the cost of increased patient risk. Applicants are pushed to improve decision-making without avoidable harms such as unnecessary radiation exposure, excessive heat, or other safety concerns that could arise from some energy-based imaging systems.
What imaging or diagnostic technology approaches are mentioned as examples?
The announcement highlights several approaches applicants may explore, including optical coherence tomography (OCT), OCT combined with Raman spectroscopy, and MRI image analysis techniques.
What other device or signal-based methods are called out as potentially relevant?
Examples include electrical conductivity measurement (ECM), quantitative laser fluorescence (QLF), alternating current impedance spectroscopy, multiphoton imaging, infrared thermography, infrared fluorescence, ultrasound, and terahertz imaging.
Are applicants limited to the listed imaging modalities?
No. While the opportunity provides examples of relevant platforms, it explicitly welcomes entirely new imaging modalities. Novel physics, new contrast mechanisms, new combinations of modalities, and improved computational interpretation methods are within scope as long as they address the clinical needs described.
What grant mechanism is used for this opportunity?
This is a discretionary grant mechanism under the NIH SBIR R43/R44 pathway. It generally aligns with phased small business development, commonly understood as early feasibility and development work followed by more advanced development and steps toward commercialization and implementation.
What does it mean that this is an SBIR opportunity?
Based on the information provided, SBIR indicates the opportunity is intended for eligible small businesses developing innovative technologies, using the R43/R44 mechanism to support development in phases.
Are there any cost sharing or matching requirements?
No. The announcement states there is no cost sharing or matching requirement, meaning applicants are not required to commit non-federal dollars as a condition of award.
Who is eligible to apply?
Eligibility is limited to small businesses.
Are foreign (non-U.S.) organizations eligible to apply?
No. Foreign (non-U.S.) organizations are not eligible to apply under this opportunity.
Are non-U.S. components of U.S. organizations eligible?
No. Non-U.S. components of U.S. organizations are also not eligible.
Are any foreign activities allowed at all?
Possibly. The announcement notes that "foreign components" as defined by the NIH Grants Policy Statement may be allowed in some cases. This typically means a U.S.-based applicant might include specific foreign activities or collaborations if they are well-justified and compliant with NIH policy.
What CFDA numbers are associated with this opportunity?
The opportunity is associated with CFDA 93.121 (Oral Diseases and Disorders Research) and CFDA 93.286 (Discovery and Applied Research for Technological Innovations to Improve Human Health).
Is PA-15-335 still open for applications?
No. The opportunity information indicates it is no longer open. It was posted/created on August 20, 2015, had an original and current closing date of September 7, 2018, and an archive date of October 8, 2018.
Where were the official announcement details hosted?
The official announcement and details were hosted by NIH on grants.nih.gov (as referenced in the provided information).
Who was listed as a contact for technical site access or linking issues?
The NIH Office of Extramural Research (OER) webmaster contact was listed for technical access or linking issues.
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