Opportunity Information: Apply for RFA FD 16 029
Apply for RFA FD 16 029
- The HHS-FDA in the consumer protection, food and nutrition, health sector is offering a public funding opportunity titled "Bioequivalence of Topical Products: Comparing Epidermal Pharmacokinetics by Spectroscopic Imaging Techniques (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 Apr 01, 2016 and posted on Apr 01, 2016.
- Applicants must submit their applications by Jun 03, 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.
- The number of recipients for this funding is limited to 2 candidate(s).
- 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 "Bioequivalence of Topical Products: Comparing Epidermal Pharmacokinetics by Spectroscopic Imaging Techniques (U01)" is a U.S. Food and Drug Administration (FDA) cooperative agreement aimed at improving how bioequivalence is evaluated for topical drug products. Its central goal is to fund research that advances spectroscopic imaging tools and related methods so researchers can non-invasively measure how much of a topically applied drug reaches the epidermis, how quickly it gets there, and how that drug distribution changes over time. In practice, the opportunity is focused on building a reliable way to track epidermal pharmacokinetics (PK) at or near the site of action within the skin without having to rely on invasive sampling approaches.
A key expectation of the funded work is the development or refinement of an approach that can accurately and reproducibly quantify drug levels in the epidermis across multiple depths beneath the skin surface. Rather than producing a single bulk measurement, the envisioned method should generate depth-resolved information, meaning it can estimate the amount of drug present at a series of positions from the surface downward through the epidermal layers. The ability to repeat these measurements over time on the same subject is central to the project concept, because repeated, non-destructive measurements would allow investigators to construct time courses and compare the rate and extent of drug availability in the epidermis between products. This kind of depth-by-time mapping is intended to strengthen comparisons between a reference and a test topical product, which is the practical need behind many topical bioequivalence questions.
The funding is intended to support not only the imaging technologies themselves, but also the full measurement framework around them. That includes method development, study design, data processing and analysis strategies, and reproducibility work. In other words, the FDA is looking for more than a proof-of-concept instrument demonstration; the opportunity emphasizes an "accurate, sensitive and reproducible" measurement approach that can stand up to rigorous comparisons and potentially inform regulatory science for topical drug products. Sensitivity matters because epidermal drug levels can be low and spatially heterogeneous, while reproducibility matters because a bioequivalence assessment needs confidence that observed differences reflect product performance rather than measurement noise.
Administratively, this is a discretionary funding opportunity (RFA-FD-16-029) issued by HHS-FDA under a cooperative agreement mechanism (U01). A cooperative agreement typically implies substantial FDA involvement during the project compared with a standard research grant, often through collaboration, milestone guidance, or iterative feedback relevant to regulatory science objectives. The activity category is listed under consumer protection, food and nutrition, and health, and it is associated with CFDA number 93.103.
Eligibility is broad and includes many types of U.S. organizations: state, county, and local governments; public and state-controlled and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions where relevant); for-profit organizations other than small businesses; and small businesses. The closing date for applications was June 3, 2016 (original and current), the opportunity was posted April 1, 2016, and the anticipated award structure indicated up to two awards with an award ceiling of $250,000.
Overall, the opportunity is best understood as targeted regulatory science funding to help create a practical, non-invasive, depth-resolved way to measure epidermal drug exposure over time using spectroscopic imaging. If successful, the resulting methods could make topical bioequivalence evaluation more direct and informative by focusing on drug availability in the epidermis near the site of action, potentially reducing reliance on more invasive or indirect approaches and improving confidence in comparative performance assessments between topical products.
FAQs: Bioequivalence of Topical Products - Comparing Epidermal Pharmacokinetics by Spectroscopic Imaging Techniques (U01)
What is the name of this grant opportunity?
The opportunity is titled "Bioequivalence of Topical Products: Comparing Epidermal Pharmacokinetics by Spectroscopic Imaging Techniques (U01)."
Which federal agency is offering this funding?
This is a U.S. Food and Drug Administration (FDA) funding opportunity issued under HHS-FDA.
What type of funding mechanism is used?
The mechanism is a cooperative agreement (U01). This generally indicates substantial FDA involvement during the project compared with a standard research grant.
What is the opportunity number (RFA)?
The RFA number is RFA-FD-16-029.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.103.
What is the main purpose of the grant?
The central goal is to improve how bioequivalence is evaluated for topical drug products by funding research that advances spectroscopic imaging tools and related methods to non-invasively measure epidermal pharmacokinetics (PK).
What problem is the FDA trying to solve with this funding?
The FDA is aiming to create a practical, reliable way to track how much of a topically applied drug reaches the epidermis, how fast it gets there, and how its distribution changes over time, without relying on invasive sampling approaches.
What does "epidermal pharmacokinetics (PK)" mean in the context of this opportunity?
In this context, it refers to measuring drug exposure in the epidermis at or near the site of action within the skin, including how drug levels change over time after topical application.
What kinds of technologies does the opportunity emphasize?
The opportunity emphasizes spectroscopic imaging techniques and related methods capable of non-invasive measurement of drug levels in the epidermis.
Is non-invasive measurement a requirement or just a preference?
Non-invasive measurement is central to the project concept. The intended approach should avoid destructive or invasive sampling so that repeated measurements can be made on the same subject over time.
What is meant by "depth-resolved" measurement?
Depth-resolved measurement means generating information across multiple depths beneath the skin surface. Instead of a single bulk value, the method should estimate drug amounts at a series of positions from the surface downward through the epidermal layers.
Does the FDA want just a single measurement, or measurements over time?
Measurements over time are a key expectation. The approach should support repeated, non-destructive measurements on the same subject to construct time courses of epidermal drug availability.
Why is the ability to repeat measurements on the same subject important?
Repeated measurements enable depth-by-time mapping of drug exposure in the epidermis, which supports comparisons of the rate and extent of drug availability between topical products.
How does this research connect to topical bioequivalence?
The methods are intended to strengthen comparisons between a reference and a test topical product by directly characterizing drug availability in the epidermis near the site of action.
What specific performance qualities does the FDA emphasize for the measurement approach?
The opportunity emphasizes an approach that is accurate, sensitive, and reproducible, suitable for rigorous comparisons and potentially informative for regulatory science.
Why is sensitivity specifically important for this work?
Sensitivity matters because epidermal drug levels can be low and spatially heterogeneous, so the method must be able to detect and quantify small, unevenly distributed amounts reliably.
Why is reproducibility specifically important for this work?
Reproducibility matters because bioequivalence assessments require confidence that observed differences reflect product performance rather than measurement noise.
Is the FDA funding only the imaging instrument itself?
No. The funding is intended to support the full measurement framework, including method development, study design, data processing and analysis strategies, and reproducibility work.
Is a proof-of-concept demonstration sufficient for this opportunity?
The opportunity emphasizes more than a proof-of-concept instrument demonstration. It calls for a measurement approach that is accurate, sensitive, and reproducible and can stand up to rigorous comparisons.
What activity categories are associated with this opportunity?
The activity category is listed under consumer protection, food and nutrition, and health.
How many awards were anticipated?
The anticipated award structure indicated up to two awards.
What was the award ceiling?
The award ceiling was $250,000.
When was the opportunity posted?
The opportunity was posted on April 1, 2016.
What was the application closing date?
The closing date for applications was June 3, 2016 (original and current).
What types of organizations were eligible to apply?
Eligibility was broad and included state, county, and local governments; public and state-controlled and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions where relevant); for-profit organizations other than small businesses; and small businesses.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized tribal governments and other tribal organizations were included in the eligibility list.
Are for-profit entities eligible?
Yes. For-profit organizations other than small businesses were listed as eligible, and small businesses were also listed as eligible.
What does it mean that the opportunity is "discretionary"?
The opportunity is described as discretionary funding. (No additional definition or requirements are provided in the opportunity summary.)
What is the practical outcome the FDA is hoping for if the project succeeds?
The intended outcome is a practical, non-invasive, depth-resolved method to measure epidermal drug exposure over time, supporting more direct and informative topical bioequivalence evaluations and potentially reducing reliance on invasive or indirect approaches.
How might the results be used?
The work is framed as regulatory science funding, so successful methods could inform how topical bioequivalence is evaluated by focusing on epidermal drug availability near the site of action.
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