Opportunity Information: Apply for RFA FD 24 008
This FDA funding opportunity (RFA-FD-24-008) supports research aimed at improving how scientists measure what happens to a drug after it is applied to the skin. The central goal is to advance non-invasive technologies, especially quantitative tomography-based approaches, that can measure and compare the rate and extent of drug availability at or near the site of action within the skin while the subject is alive (in vivo). In practical terms, the FDA is looking for tools and study methods that can track how much drug is present in different layers of the skin over time, without relying on more invasive sampling techniques that may be slow, variable, or difficult to repeat.
The project focus is on building an accurate, sensitive, and reproducible way to rapidly estimate the relative amount of drug located at a series of depths beneath the skin surface. A key feature is repeated, serial measurement over time, so that a full cutaneous pharmacokinetic (PK) profile can be generated at selected depths, such as within the epidermis. This implies not just a one-time measurement, but a method that can be used to follow drug uptake, distribution, and decline in the skin across multiple timepoints, producing time-course data similar in spirit to traditional blood PK, but localized to skin layers where topical drugs act.
The funding is meant to cover the research and development needed to make this possible, including the design or refinement of hardware (apparatus), measurement procedures, clinical study designs, and data analysis methods. In other words, it is not limited to inventing a device; it also supports the supporting ecosystem needed to make the measurements scientifically credible, interpretable, and usable in a regulatory context. That includes demonstrating that the approach can produce consistent results, that it can detect meaningful differences, and that it can be applied in a way that supports comparisons between products.
A major intended downstream outcome is to enable an alternative, scientifically valid in vivo method for demonstrating bioequivalence (BE) of topical drug products. Bioequivalence for topical products can be challenging because drug levels in blood may not reflect local delivery to the skin, and conventional clinical endpoint studies can be expensive and time-consuming. By developing a dependable cutaneous PK approach, the FDA is signaling interest in tools that could make BE assessments more efficient while still being rigorous, potentially accelerating development and review of topical generics and other comparable products.
Mechanically, this opportunity is offered as a cooperative agreement (U01), which typically means substantial scientific involvement or partnership from the funding agency during the project, rather than a fully investigator-driven grant with minimal agency interaction. The title specifies "Clinical Trial Required," indicating the funded work is expected to include a clinical study component rather than being purely bench or engineering development. The agency listed is the Food and Drug Administration, and the activity category is associated with consumer protection and related areas (CFDA 93.103).
The opportunity is broadly open to many applicant types, including state, local, and tribal governments; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (including small businesses); and other unrestricted applicants. The original closing date was April 8, 2024. The award ceiling is $250,000, and the FDA anticipated making one award, suggesting a single, focused project will be supported rather than a large multi-award program.
Overall, the opportunity is essentially a targeted push to develop and validate non-invasive pharmacokinetic tomography (or similar quantitative imaging) as a practical way to measure topical drug presence within skin layers over time. The FDA is looking for a solution that is not only technically innovative but also reproducible and fit for purpose in comparative testing, with the longer-term aim of supporting more efficient regulatory pathways for establishing bioequivalence of topical products.Apply for RFA FD 24 008
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)" 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 2024-01-15.
- Applicants must submit their applications by 2024-04-08. (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 1 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, Unrestricted.
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Frequently Asked Questions (FAQs) - FDA RFA-FD-24-008
What is the main purpose of this FDA funding opportunity (RFA-FD-24-008)?
This opportunity supports research to improve how scientists measure what happens to a drug after it is applied to the skin. The focus is on building and validating non-invasive ways to measure and compare how much drug is available at or near the site of action within the skin, while the subject is alive (in vivo).
What kind of technologies is FDA especially interested in?
FDA is especially interested in non-invasive technologies, particularly quantitative tomography-based approaches, that can estimate drug levels at multiple depths beneath the skin surface over time.
What does "non-invasive" mean in the context of this opportunity?
In this context, non-invasive means measuring drug presence in skin layers without relying on invasive sampling methods. The goal is to avoid approaches that may be slow, variable, difficult to repeat, or burdensome to subjects, and instead enable repeatable measurements over time.
What measurements is the FDA trying to enable?
The FDA is seeking tools and methods that can track how much drug is present in different layers of the skin over time, including producing rapid estimates of relative drug amounts at a series of depths below the skin surface.
Is the goal a one-time measurement or repeated measurements over time?
Repeated measurements are a key feature. The opportunity emphasizes serial measurement over time so a full cutaneous pharmacokinetic (PK) profile can be generated at selected depths (for example, within the epidermis).
What is meant by a "cutaneous PK profile" in this opportunity?
A cutaneous PK profile refers to time-course data showing drug uptake, distribution, and decline within skin layers. It is conceptually similar to traditional blood pharmacokinetics, but localized to the skin depths where topical drugs act.
Which skin depths or layers are of interest?
The opportunity describes estimating drug at a series of depths beneath the skin surface and specifically mentions selected depths such as within the epidermis. In general, the emphasis is on measuring drug availability at or near the site of action within the skin.
What are the key performance expectations for the measurement approach?
The project aims to support development of an approach that is accurate, sensitive, and reproducible, and capable of generating consistent results across repeated measurements and timepoints.
What types of work can the funding support?
The funding is intended to cover research and development needed to make non-invasive cutaneous PK measurement feasible and credible. This includes design or refinement of hardware (apparatus), measurement procedures, clinical study designs, data analysis methods, and other supporting elements needed for interpretable, scientifically defensible results.
Is this opportunity only about inventing a new device?
No. The scope is broader than device invention. It also supports study methods and the full set of procedures and analyses needed to make measurements scientifically credible, interpretable, and usable in a regulatory context.
What does FDA mean by making the approach usable in a "regulatory context"?
Based on the description, this means the approach should generate results that are consistent, can detect meaningful differences, and can support comparisons between products, which are important characteristics for regulatory decision-making.
Why is the FDA interested in this for topical drug products?
Topical bioequivalence can be challenging because blood drug levels may not reflect local delivery to the skin. Conventional clinical endpoint studies can also be expensive and time-consuming. FDA is interested in dependable in vivo cutaneous PK approaches that could make comparative evaluations more efficient while still rigorous.
How is this research expected to impact bioequivalence (BE) assessments?
A major intended downstream outcome is enabling an alternative, scientifically valid in vivo method for demonstrating bioequivalence of topical drug products by measuring drug availability in skin layers over time.
What does "bioequivalence" mean here?
In the context provided, bioequivalence refers to demonstrating that topical drug products can be compared using scientifically valid methods. The opportunity highlights the need for approaches that support comparisons between products, because traditional systemic (blood) measures may not capture local skin delivery.
What funding mechanism is used for this opportunity?
This opportunity is offered as a cooperative agreement (U01).
What does a U01 cooperative agreement imply for the project?
A U01 typically indicates substantial scientific involvement or partnership from the funding agency during the project, rather than a fully investigator-driven grant with minimal agency interaction.
Is a clinical trial required under this funding opportunity?
Yes. The title specifies "Clinical Trial Required," indicating the funded work is expected to include a clinical study component rather than being purely bench or engineering development.
Who is the sponsoring agency for this grant opportunity?
The sponsoring agency listed is the Food and Drug Administration (FDA).
What is the activity category or listing associated with this opportunity?
The activity category is associated with consumer protection and related areas, and it is listed under CFDA 93.103.
Who is eligible to apply?
The opportunity is broadly open to many applicant types, including state, local, and tribal governments; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (including small businesses); and other unrestricted applicants.
Are for-profit organizations and small businesses eligible?
Yes. For-profit organizations, including small businesses, are included among eligible applicants.
How much funding is available per award?
The award ceiling is $250,000.
How many awards did FDA anticipate making?
FDA anticipated making one award, indicating a single, focused project rather than a multi-award program.
What was the original closing date for the opportunity?
The original closing date was April 8, 2024.
What is the central technical challenge this opportunity is trying to address?
The central challenge is developing a non-invasive, quantitative, and repeatable way to measure relative drug amounts at multiple depths within the skin over time, enabling time-course cutaneous PK data without relying on invasive sampling techniques that may be difficult to repeat or highly variable.
What types of outcomes or deliverables are implied by the opportunity description?
Implied outcomes include a validated non-invasive measurement approach (often tomography-based), along with supporting hardware, procedures, clinical study methods, and data analysis workflows that together demonstrate accuracy, sensitivity, reproducibility, and suitability for comparing topical products.
How does this opportunity relate to development and review of topical generics?
The description notes that a dependable cutaneous PK approach could support more efficient bioequivalence assessments, potentially accelerating development and review of topical generics and other comparable topical products.
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