Opportunity Information: Apply for RFA FD 20 019
This grant opportunity (RFA-FD-20-019) is a U.S. Food and Drug Administration (FDA), Department of Health and Human Services cooperative agreement (U01) focused on improving how topical drug products are evaluated for bioavailability and bioequivalence directly within the skin. The central aim is to clarify how standard pharmacokinetic concepts that are routinely used for drugs measured in blood or plasma (such as dose, fraction absorbed, apparent volume of distribution, Cmax, and AUC to infinity) should be interpreted, modified, or re-defined when the measurement site is the dermis rather than the systemic circulation. In practical terms, the agency is looking for research that can translate classic PK thinking into dermal pharmacokinetics in a scientifically sound way, so that measurements taken in skin tissue can support regulatory-quality assessments of how much drug reaches the intended local site of action and how quickly it gets there.
A major emphasis of the opportunity is the evaluation and refinement of in vivo dermal pharmacokinetic sampling methods, specifically dermal microdialysis (dMD) and dermal open flow microperfusion (dOFM). These techniques sample drug concentrations in or near the dermis over time, which can potentially provide a direct, local PK profile at the site of action for many topical products. The funded work is expected to determine how to design these studies correctly (for example, probe placement, sampling schedules, duration of sampling, controls, and handling of variability) and how to analyze the resulting concentration-time data to generate meaningful dermal PK endpoints. In addition to defining or adapting endpoints like Cmax and AUC for dermal data, the research is intended to address the relationship between a topically applied dose and the measurable dermal exposure, including how to interpret concepts like the fraction of drug absorbed into the dermis when the drug is largely intended to act locally rather than systemically.
Another key objective is sensitivity and discrimination: the FDA wants to know how well dermal PK methods can detect and differentiate meaningful differences in drug concentrations within the skin. That includes assessing whether dMD or dOFM can reliably distinguish between formulations that are truly equivalent versus those that differ in delivery to the dermal target site. This speaks directly to topical bioequivalence questions, where traditional systemic PK may not be appropriate and where alternative approaches need to be robust enough to support regulatory decisions. The end goal is to establish study designs, performance expectations, and analytical approaches that make dermal PK methods suitable for evaluating topical bioavailability and bioequivalence based on endpoints derived from dermal concentration-time profiles.
Administratively, the opportunity falls under the category of discretionary funding and uses a cooperative agreement mechanism, meaning the FDA is likely to have substantial scientific involvement during the project compared to a standard grant. The program is listed under CFDA 93.103 and is categorized under Agriculture, Consumer Protection, Food and Nutrition (reflecting FDA program classifications). The award ceiling is $1,000,000, with an expectation of up to 5 awards. Eligible applicants are broad and include various levels of government, public and private institutions of higher education, federally recognized tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, nonprofit organizations (with or without 501(c)(3) status), and small businesses, along with other entities as clarified in the full eligibility text. The opportunity was created on December 19, 2019, with an original closing date of February 27, 2020, and it explicitly states that clinical trials are not allowed, indicating the research should focus on methodological, mechanistic, or non-clinical-trial human research activities consistent with the announcement rather than interventional clinical trial designs.Apply for RFA FD 20 019
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Bioequivalence of Topical Products: Elucidating Fundamental Principles of Dermal Pharmacokinetics for Microdialysis or Microperfusion Techniques (U01) Clinical Trials Not Allowed" 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 Dec 19, 2019.
- Applicants must submit their applications by Feb 27, 2020. (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 $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, 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, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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