Opportunity Information: Apply for RFA FD 21 019
This funding opportunity, titled "Dermal Physiologically-based Pharmacokinetic (PBPK) Models Accounting for the Absorption and Evaporation of Vehicle/Co-solvent following the Application of Generic Dermatological Products (U01)" (RFA-FD-21-019), is a research-focused cooperative agreement sponsored by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). It sits in the broader activity areas of consumer protection and science and technology research, and it is associated with CFDA number 93.103. The intent is to support work that improves how researchers and regulators model what happens after a topical dermatological drug product is applied to skin, especially for generic products where demonstrating comparable performance can be challenging.
The central goal is to develop an enhanced, mechanistic dermal PBPK model that more realistically represents the physical and chemical changes that occur in the product after it is spread on skin. Many topical formulations contain vehicles and co-solvents that do not simply remain constant after application. Instead, they can be absorbed into skin and/or evaporate from the surface over time. As those processes occur, the formulation can effectively "transform" (often described as formulation metamorphosis), changing the environment that the drug experiences at the skin surface. That, in turn, can change the drug's thermodynamic activity, concentration, partitioning behavior, and overall driving force for permeation into and through the skin. The opportunity specifically calls for modeling the absorption and evaporation of vehicle/co-solvent simultaneously and incorporating the downstream impact of these dynamic processes on the drug's movement through skin layers.
The model envisioned under this announcement is intended to go beyond static assumptions about the formulation and instead treat the system as time-dependent, capturing how the vehicle composition evolves and how that evolution alters drug permeation. The output of this work is meant to help predict both local exposure (drug levels in relevant skin compartments) and systemic exposure (drug levels that reach circulation) following topical application. In practical terms, a model like this could help explain why two products with the same nominal drug concentration might deliver different amounts of drug into skin depending on excipient choice, solvent volatility, or the rate at which a vehicle component partitions into skin.
From an FDA and generic drug development perspective, the purpose is not just academic modeling. The agency is signaling that a better mechanistic PBPK framework could be used to inform decisions related to generic dermatological product development and evaluation. That includes improving scientific understanding of how formulation changes after application influence absorption, and potentially supporting more efficient approaches to demonstrating equivalence or anticipating performance differences when making formulation or process changes. In other words, the deliverable is expected to be a model with regulatory relevance that can improve prediction and interpretation of topical drug exposure in skin and systemically.
The award mechanism is a U01 cooperative agreement, which typically means the FDA expects substantial involvement during the project period (for example, coordination on aims, data needs, model features, performance expectations, and deliverables) rather than a hands-off grant. The announcement anticipated up to two awards, with an award ceiling of $500,000. The opportunity was created on February 17, 2021, with an original closing date of April 22, 2021.
Eligibility is broad and includes many types of organizations that can carry out the modeling, experimental, and translational work needed for this kind of project. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and 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 (including those other than small businesses); small businesses; and other entities as described in the full eligibility text. This wide eligibility reflects the multidisciplinary nature of dermal PBPK work, which can involve pharmaceutics, skin biology, transport modeling, computational science, and experimental characterization of evaporation and absorption phenomena.
Overall, the opportunity is aimed at advancing dermal PBPK modeling for topical generics by explicitly addressing a real-world behavior of dermatological formulations: they change after application. By building a model that jointly accounts for vehicle/co-solvent evaporation and absorption and links those dynamics to drug permeation, the FDA is seeking a tool that can better predict local and systemic exposure, strengthen the scientific basis for generic dermatological product development, and deepen understanding of how post-application formulation metamorphosis shapes skin absorption outcomes.Apply for RFA FD 21 019
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, food and nutrition, science and technology and other research and development sector is offering a public funding opportunity titled "Dermal Physiologically-based Pharmacokinetic (PBPK) Models Accounting for the Absorption and Evaporation of Vehicle/Co-solvent following the Application of Generic Dermatological 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 Feb 17, 2021.
- Applicants must submit their applications by Apr 22, 2021. (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 $500,000.00 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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