Opportunity Information: Apply for RFA FD 23 015
This grant opportunity from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA) supports research to build and validate a next-generation, mechanistic dermal physiologically-based pharmacokinetic (PBPK) modeling tool for topical drug products. The central idea is to create a quantitative, multi-functional in silico framework that can realistically simulate how an active pharmaceutical ingredient (API) moves from a formulation placed on the skin surface into and through skin layers (and potentially into systemic circulation) in "virtual subjects." A key emphasis is that the model should not treat the applied product as static. Instead, it should explicitly account for how topical formulations can change after application (the opportunity describes this as product "metamorphosis"), including time-dependent shifts in the vehicle and microenvironment that may alter drug release, partitioning, and permeation.
The project goal is practical and regulatory-relevant: evaluate whether the tool can predict skin absorption for both the reference listed drug (RLD) and a proposed generic (test) product, even when the two have different formulation compositions and product quality attributes. Rather than relying only on empirical curve fitting, the FDA is seeking an enhanced mechanistic PBPK model that incorporates formulation quality attributes and their dynamic evolution on the skin. In effect, the model is expected to connect "what the product is" (composition and critical quality attributes) and "what it becomes on skin over time" (post-application changes) to "what the body sees" (dermal uptake and exposure). If successful, the tool would help identify which parameters most strongly influence therapeutic equivalence between an RLD and a test topical product, and it could be used to inform generic drug development decisions, including understanding where formulation differences are likely to matter for local delivery into skin.
A major deliverable implied in the announcement is validation using appropriate datasets. That means the model is not only expected to be developed, but also tested against credible experimental and/or clinical data sources relevant to dermal absorption and topical product performance. The end product is intended to be a validated quantitative tool that FDA and stakeholders could use to explore formulation- and quality-driven drivers of bioavailability and bioequivalence for topical dermatologic products, reducing uncertainty in predicting whether two products will perform similarly when applied to skin.
Mechanistically, the opportunity is centered on dermal PBPK modeling, which typically represents skin as layered compartments (for example, stratum corneum, viable epidermis, dermis) coupled with processes such as diffusion, partitioning, binding, metabolism, and clearance to the microcirculation. What makes this funding call distinct is its explicit requirement to incorporate drug product quality attributes and the evolving state of the dosage form after application, which can influence thermodynamic activity of the drug, evaporation of solvents, changes in viscosity, crystallization or supersaturation, changes in hydration/occlusion, and other time-dependent factors that can dramatically alter dermal flux. The model is meant to be multi-purpose and multi-functional, suggesting broad applicability across topical product types and the ability to run scenario analyses to determine sensitivity to formulation attributes and post-application changes.
From an administrative standpoint, the opportunity is offered as a cooperative agreement (U01), meaning the FDA is expected to have substantial scientific or programmatic involvement during the project rather than acting only as a passive funder. The funding opportunity number is RFA-FD-23-015, categorized as discretionary funding within consumer protection, science and technology, and other research and development, under CFDA number 93.103. The award ceiling is $750,000, with an expectation of making two awards. The original posting date is January 5, 2023, and the original closing date is March 21, 2023. The announcement is labeled "Clinical Trial Optional," indicating that while clinical studies are not required, they may be proposed if they are appropriate to development and validation of the modeling tool.
Eligibility is broad and includes many public and private entities: state, county, city/township, and 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 or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses, along with other eligible applicants as further clarified in the full announcement text.
Overall, this opportunity is aimed at strengthening the scientific basis for evaluating topical drug products by advancing dermal PBPK modeling beyond traditional approaches, specifically by integrating formulation quality attributes and their time-dependent transformation on skin. The intended impact is to provide a validated computational tool that can help pinpoint the factors that drive (or undermine) therapeutic equivalence between an RLD and a generic topical product, ultimately supporting more efficient, science-based generic development and regulatory decision-making for topical dermatologic drugs.Apply for RFA FD 23 015
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, science and technology and other research and development sector is offering a public funding opportunity titled "Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional" 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 Jan 05, 2023.
- Applicants must submit their applications by Mar 21, 2023. (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 $750,000.00 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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Frequently Asked Questions (FAQs)
What is the purpose of this FDA grant opportunity?
This opportunity supports research to build and validate a next-generation, mechanistic dermal physiologically-based pharmacokinetic (PBPK) modeling tool for topical drug products. The goal is a quantitative, multi-functional in silico framework that can realistically simulate how an active pharmaceutical ingredient (API) moves from a formulation on the skin surface into and through skin layers, and potentially into systemic circulation, in virtual subjects.
Which agency and program are sponsoring this grant?
The sponsor is the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA). The program is associated with CFDA number 93.103 and is categorized as discretionary funding within consumer protection, science and technology, and other research and development.
What is the funding opportunity number?
The funding opportunity number is RFA-FD-23-015.
What type of award is this?
This is a cooperative agreement (U01). That means the FDA is expected to have substantial scientific or programmatic involvement during the project, rather than acting only as a passive funder.
What does it mean that this is a cooperative agreement (U01) in practice?
Based on the announcement description, the project is expected to be conducted with meaningful FDA involvement in the scientific and/or programmatic direction of the work, consistent with a cooperative agreement mechanism.
What is the maximum award amount?
The award ceiling is $750,000.
How many awards does FDA expect to make?
The opportunity states an expectation of making two awards.
When was this opportunity posted and when did it close?
The original posting date is January 5, 2023, and the original closing date is March 21, 2023.
Is a clinical trial required?
No. The announcement is labeled "Clinical Trial Optional," meaning clinical studies are not required, but they may be proposed if they are appropriate for developing and validating the modeling tool.
What is dermal PBPK modeling in the context of this opportunity?
Dermal PBPK modeling typically represents skin as layered compartments (for example, stratum corneum, viable epidermis, dermis) and includes processes such as diffusion, partitioning, binding, metabolism, and clearance to microcirculation. This opportunity focuses on advancing that framework for topical drug products.
What makes this PBPK modeling funding call distinct from traditional approaches?
A key requirement is that the model must incorporate drug product quality attributes and explicitly represent the evolving state of the dosage form after application. The opportunity emphasizes that a topical product should not be treated as static once applied to skin.
What is meant by product "metamorphosis" after topical application?
The opportunity describes product "metamorphosis" as time-dependent changes in the topical formulation and the microenvironment after it is applied to skin. These shifts can alter drug release, partitioning, and permeation over time.
What kinds of post-application changes should the model account for?
The announcement highlights factors such as evaporation of solvents, changes in viscosity, crystallization or supersaturation, changes in hydration/occlusion, and other time-dependent effects that can change the thermodynamic activity of the drug and dramatically alter dermal flux.
What is the expected end product of the project?
The intended end product is a validated quantitative dermal PBPK modeling tool that FDA and stakeholders could use to explore formulation- and quality-driven drivers of bioavailability and bioequivalence for topical dermatologic products.
How is "validation" addressed in this opportunity?
A major deliverable implied in the announcement is validation using appropriate datasets. The model is expected not only to be developed, but also tested against credible experimental and/or clinical data sources relevant to dermal absorption and topical product performance.
What is the central scientific idea behind the tool being developed?
The central idea is to create a mechanistic, quantitative, multi-functional in silico framework that links (1) what the product is (composition and critical quality attributes), (2) what it becomes on skin over time (post-application evolution), and (3) what the body sees (dermal uptake and exposure).
How is the model expected to handle the topical formulation itself?
The model is expected to explicitly account for changes in the formulation after application rather than assuming the applied product remains unchanged. This includes time-dependent shifts in the vehicle and microenvironment that influence release and permeation.
What regulatory question is the tool intended to help address?
The project goal is to evaluate whether the tool can predict skin absorption for both the reference listed drug (RLD) and a proposed generic (test) topical product, including situations where the two products differ in formulation composition and product quality attributes.
Does the opportunity focus only on empirical curve fitting?
No. The opportunity explicitly seeks an enhanced mechanistic PBPK model rather than relying only on empirical curve fitting. The model is expected to incorporate formulation quality attributes and their dynamic evolution on the skin.
What are "product quality attributes" in the context of this announcement?
The opportunity refers to formulation composition and critical quality attributes, and emphasizes incorporating how those attributes (and the product state) evolve after application in ways that affect drug release, partitioning, and permeation.
How could this tool support generic topical drug development?
If successful, the tool could help identify which parameters most strongly influence therapeutic equivalence between an RLD and a test topical product, and inform development decisions by clarifying where formulation differences are likely to matter for local delivery into skin.
What does "multi-purpose" and "multi-functional" imply for the model?
The announcement suggests broad applicability across topical product types and the ability to run scenario analyses, including sensitivity assessments related to formulation attributes and post-application changes.
Is systemic exposure within scope, or only local skin layers?
The opportunity emphasizes movement of API into and through skin layers and notes that the framework can potentially include entry into systemic circulation, as simulated in virtual subjects.
What kinds of analyses is the model expected to enable?
The announcement anticipates the ability to explore and pinpoint drivers of dermal uptake, bioavailability, and bioequivalence, including scenario analyses to determine sensitivity to formulation quality attributes and time-dependent post-application transformation.
Who is eligible to apply?
Eligibility is broad and includes: state, county, city/township, and 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 or without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and other eligible applicants as further clarified in the full announcement text.
Are small businesses eligible?
Yes. Small businesses are included in the listed eligible applicant categories.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are explicitly listed, and small businesses are also listed separately as eligible.
Are universities and colleges eligible?
Yes. Both public/state-controlled institutions of higher education and private institutions of higher education are listed as eligible.
Are government entities eligible?
Yes. Multiple government entity types are listed as eligible, including state, county, city/township, special district governments, and independent school districts.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized Native American tribal governments and other tribal organizations are listed as eligible.
What is the intended impact of the funded research?
The intended impact is to strengthen the scientific basis for evaluating topical drug products by advancing dermal PBPK modeling to integrate formulation quality attributes and their time-dependent transformation on skin, reducing uncertainty in predicting whether two products will perform similarly when applied to skin.
What topical products are in scope?
The opportunity is focused on topical drug products and specifically highlights topical dermatologic products in the discussion of bioavailability and bioequivalence use cases.
What are RLD and test products in this context?
The reference listed drug (RLD) is the reference product, and the test product refers to a proposed generic topical product. The tool is intended to assess whether it can predict skin absorption for both, including when they differ in composition and quality attributes.
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