In Vitro Approaches to Evaluate and Compare the Adhesion Performance of Transdermal and Topical Delivery Systems (TDS) (U01) Clinical Trial Required | RFA FD 22 015

Opportunity Information: Apply for RFA FD 22 015

This grant opportunity, titled "In Vitro Approaches to Evaluate and Compare the Adhesion Performance of Transdermal and Topical Delivery Systems (TDS) (U01) Clinical Trial Required," is a Food and Drug Administration (FDA) cooperative agreement aimed at improving how adhesion performance is tested for transdermal and topical delivery systems. These products, often patches or topical systems that rely on sticking properly to the skin, can fail if they lift, peel, shift, or fall off, which can reduce dosing reliability and create safety or effectiveness concerns. The central goal of the program is to fund research that develops laboratory-based (in vitro) test methods that meaningfully correlate with, and can help predict, real-world (in vivo) adhesion performance on patients.

A major driver behind the opportunity is the challenge of comparing prospective generic TDS products to their reference listed drugs. Even when two products are intended to be equivalent, differences in product design, formulation, manufacturing processes, or key quality attributes can change how well the product adheres to skin. The FDA is specifically interested in methods that can detect and explain those differences in a way that is relevant to clinical use. In practical terms, the funded work is expected to produce standardized or at least well-justified in vitro approaches that can evaluate adhesion quality, identify potential adhesion-related failure modes during development, and help anticipate when a generic product might behave differently from the reference product once worn under real conditions.

The expected impact is twofold. For industry, better in vitro adhesion tests could become development tools to troubleshoot problems early, reduce costly iteration, and support stronger evidence packages when pursuing generic approvals. For the FDA, these methods could support regulatory assessment by providing more predictive, mechanistic, and reproducible data when evaluating whether observed differences between a test and reference TDS are likely to matter for adhesion performance in actual use. The emphasis on correlation to in vivo performance signals that simple bench measurements are not enough; the work should connect laboratory results to clinically meaningful adhesion outcomes.

Administratively, this is a discretionary funding opportunity issued by the U.S. Department of Health and Human Services (HHS), FDA, using a cooperative agreement mechanism (U01). A cooperative agreement generally means there is substantial federal scientific or programmatic involvement during the project, so awardees should expect active engagement with the FDA as the research progresses. The program is categorized under science and technology and other research and development, with CFDA number 93.103. The opportunity number is RFA-FD-22-015. It was created on January 12, 2022, with an original closing date of March 31, 2022.

The funding profile indicates a single anticipated award (ExpectedAwards: 1) with an award ceiling of $1,250,000. Eligibility is broad and includes a wide range of organizations: state, county, and local 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; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations other than small businesses; and small businesses. The listing also labels the opportunity as "Clinical Trial Required," which signals that applicants needed to account for the possibility that human-subject or clinical components could be involved, even though the scientific focus described is on developing in vitro methods that relate to in vivo outcomes.

Overall, the opportunity is designed to strengthen the scientific foundation for evaluating adhesion in transdermal and topical delivery systems, particularly to support rigorous comparison of generic products to reference products. By funding development of predictive in vitro tools, the FDA is seeking methods that can better forecast real-world adhesion behavior, improve product development decision-making, and enhance regulatory confidence when determining whether differences in design or formulation translate into meaningful differences in performance on the skin.

• The Department of Health and Human Services, Food and Drug Administration in the science and technology and other research and development sector is offering a public funding opportunity titled "In Vitro Approaches to Evaluate and Compare the Adhesion Performance of Transdermal and Topical Delivery Systems (TDS) (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 Jan 12, 2022.
• Applicants must submit their applications by Mar 31, 2022. (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 $1,250,000.00 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.

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