Opportunity Information: Apply for RFA FD 16 010
Apply for RFA FD 16 010
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Use of Imaging and Digital Image Analysis Software/s to Evaluate Transdermal Irritation and Non - inferiority of Generic Transdermal Products (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Mar 28, 2016 and posted on Mar 28, 2016.
- Applicants must submit their applications by May 31, 2016. (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 $250,000.00 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 (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The grant opportunity titled "Use of Imaging and Digital Image Analysis Software/s to Evaluate Transdermal Irritation and Non-inferiority of Generic Transdermal Products (U01)" (Funding Opportunity Number RFA FD 16 010) focuses on improving how skin irritation is measured in studies of transdermal drug delivery systems, such as patches. In traditional irritation evaluations, trained human observers visually inspect the skin and score redness or other signs of irritation after product application. The opportunity highlights a key problem with this approach: it can introduce observer bias and variability, especially because the different transdermal systems being compared in these studies often look visibly different. That visual dissimilarity can unintentionally influence scoring, making it harder to be confident that irritation assessments are consistent across subjects, sites, or evaluators.
The central aim of the funding announcement is to support research that tests whether digital photography (or similar imaging methods) combined with digital image analysis software can be used to quantify transdermal irritation more objectively and reliably than purely visual clinical grading. The idea is that standardized image capture and software-based measurement could reduce subjectivity, improve repeatability, and create more consistent irritation endpoints. This is particularly important for studies that compare a proposed generic transdermal product to a reference (brand) product, where regulators and sponsors need confidence that observed differences (or lack of differences) are real and not artifacts of inconsistent scoring.
A major emphasis of the announcement is the potential regulatory and scientific value of using digital imaging to support non-inferiority analyses for generic transdermal systems. Non-inferiority, in this context, generally means demonstrating that the generic product is not worse than the reference product by more than a predefined margin for a given endpoint, here centered on irritation outcomes. Because irritation scoring can be noisy when based on human observation, a more quantitative imaging approach could strengthen comparisons and help clarify whether two products have similar irritation profiles. In practical terms, the research supported by this opportunity would be expected to explore whether imaging-derived metrics can serve as dependable measures of irritation severity and whether those metrics can be used in statistical frameworks designed for non-inferiority evaluations.
From an administrative and funding standpoint, this was a discretionary funding opportunity issued as a Cooperative Agreement (U01), which typically means that the funding agency expects substantial involvement in the project during its conduct, such as collaboration on technical direction, study design considerations, or data interpretation expectations. The activity category is Health, and the opportunity is associated with CFDA number 93.103. The agency listed is HHS-NIH11. The opportunity was posted on March 28, 2016, created the same day, and had an original and current closing date of May 31, 2016. The award ceiling is listed as $250,000, indicating the maximum award amount anticipated under this announcement. The "ExpectedAwards" field is not populated in the provided data, so the number of awards was not specified there.
Eligibility for applicants was broad and included many organization types: state, county, city, and 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 tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other applicants as described in additional eligibility text (not included in the excerpt). Overall, the opportunity is aimed at building evidence on whether imaging and image analysis tools can improve the objectivity and reliability of irritation measurement in transdermal product studies and whether those tools can be credibly used to support non-inferiority comparisons of generic transdermal products.
Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity is titled "Use of Imaging and Digital Image Analysis Software/s to Evaluate Transdermal Irritation and Non-inferiority of Generic Transdermal Products (U01)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA FD 16 010.
What is the main purpose of this funding opportunity?
The purpose is to support research that evaluates whether digital photography (or similar imaging methods) combined with digital image analysis software can measure transdermal irritation more objectively and reliably than traditional visual clinical grading by human observers.
What problem is the opportunity trying to solve in transdermal irritation studies?
Traditional irritation evaluations often rely on trained observers visually inspecting skin and scoring redness or other irritation signs. This approach can introduce observer bias and variability, especially when the transdermal systems being compared look visibly different, which can unintentionally influence scoring and reduce confidence in consistency across subjects, sites, or evaluators.
What kinds of products are the focus of the research?
The focus is on transdermal drug delivery systems, such as patches, including studies that compare proposed generic transdermal products to reference (brand) products.
How does imaging and software-based analysis help compared to visual scoring?
The opportunity is based on the concept that standardized image capture plus software-based measurement could reduce subjectivity, improve repeatability, and create more consistent irritation endpoints than purely visual clinical grading.
What does "digital imaging" mean in the context of this opportunity?
In this context, digital imaging refers to using digital photography or similar imaging methods to capture standardized images of the skin after product application, which can then be analyzed using digital image analysis software to quantify irritation.
What is meant by "digital image analysis software" in this opportunity?
It refers to software tools that can analyze captured skin images and generate quantitative metrics intended to reflect irritation severity (for example, measuring redness or related features) in a way that is less dependent on human judgment.
Why does the announcement emphasize visible differences between products?
Because the different transdermal systems being compared in studies may look visibly different, those visual differences can unintentionally influence human observer scoring, increasing the risk of bias and variability in irritation assessments.
What is the "central aim" described in the announcement?
The central aim is to test whether imaging methods paired with image analysis software can quantify transdermal irritation more objectively and reliably than visual clinical grading.
What does "non-inferiority" mean here?
Non-inferiority, in this context, generally means demonstrating that the generic transdermal product is not worse than the reference product by more than a predefined margin for an endpoint focused on irritation outcomes.
Why is non-inferiority analysis important for generic transdermal products?
Because regulators and sponsors need confidence that any observed differences (or lack of differences) in irritation are real and not artifacts of inconsistent or subjective scoring. A more quantitative imaging-based approach could strengthen these comparisons.
What role do irritation endpoints play in this opportunity?
Irritation endpoints are central because the funded research is expected to examine whether imaging-derived metrics can serve as dependable measures of irritation severity and whether those metrics can be used in statistical frameworks for non-inferiority evaluations.
What kinds of outcomes are researchers expected to investigate?
Based on the description, the work would be expected to explore (1) whether imaging-derived metrics are dependable measures of irritation severity and (2) whether those metrics can be used within statistical approaches designed for non-inferiority comparisons of generic versus reference transdermal products.
What is the funding mechanism for this opportunity?
This is a Cooperative Agreement (U01).
What does a Cooperative Agreement (U01) imply about agency involvement?
A U01 typically means the funding agency expects substantial involvement during the project, such as collaboration on technical direction, study design considerations, or expectations related to data interpretation.
Is this opportunity categorized under a specific activity area?
Yes. The activity category listed is Health.
What CFDA number is associated with this opportunity?
The opportunity is associated with CFDA number 93.103.
Which agency is listed for this grant opportunity?
The agency listed is HHS-NIH11.
When was the opportunity posted?
It was posted on March 28, 2016.
When was the opportunity created?
It was created on March 28, 2016.
What was the closing date for applications?
The original closing date was May 31, 2016, and the current closing date is also May 31, 2016.
What is the maximum award amount (award ceiling)?
The award ceiling is listed as $250,000, meaning the maximum award amount anticipated under this announcement.
How many awards were expected?
The number of expected awards was not specified in the provided information (the "ExpectedAwards" field was not populated).
Who is eligible to apply?
Eligibility is broad and includes: state, county, city, and 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 tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with and without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other applicants as described in additional eligibility text (not included in the excerpt).
Are both nonprofit and for-profit organizations eligible?
Yes. Nonprofit organizations (with and without 501(c)(3) status) and for-profit organizations (including small businesses and for-profit organizations other than small businesses) are included in the eligibility list provided.
Are government entities eligible to apply?
Yes. The eligibility list includes multiple government entity types, including state, county, city, and township governments, as well as special district governments and independent school districts.
Are tribal entities eligible to apply?
Yes. Federally recognized Native American tribal governments and other tribal organizations are included in the eligibility list.
Are universities and colleges eligible?
Yes. Both public and state-controlled institutions of higher education and private institutions of higher education are included in the eligibility list.
Does the opportunity specify additional eligibility requirements?
The excerpt notes that "other applicants" may be eligible as described in additional eligibility text, but that additional text was not included in the provided information.
What is the overall intended impact of the funded research?
The intended impact is to build evidence on whether imaging and image analysis tools can improve the objectivity and reliability of irritation measurement in transdermal product studies and whether those tools can credibly support non-inferiority comparisons of generic transdermal products.
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