In Vitro Based Approaches to Evaluate the Bioequivalence of Generic Rectal and Vaginal Products | RFA FD 22 014

Opportunity Information: Apply for RFA FD 22 014

The Food and Drug Administration (FDA) grant opportunity titled "In Vitro Based Approaches to Evaluate the Bioequivalence of Generic Rectal and Vaginal Products" (Funding Opportunity Number RFA-FD-22-014) is a discretionary research and development program designed to improve how bioequivalence (BE) is evaluated for generic rectal and vaginal topical drug products. The central goal is to fund studies that clarify the special scientific and technical issues that make BE assessment for these products different from other dosage forms. Because rectal and vaginal products often act locally and can be influenced by formulation behavior, anatomy, physiology, and product application conditions, traditional approaches to proving BE may be difficult, expensive, or not always the most informative. This opportunity is meant to help build stronger, more predictive methods that regulators and developers can rely on when comparing a proposed generic to its reference product.

A major emphasis of the program is the development of "biorelevant performance tests" that can be used as part of product-characterization-based BE approaches. In practical terms, this points to laboratory (in vitro) testing methods that realistically mimic the conditions a rectal or vaginal product experiences during use, such as the relevant environment, fluid volumes, pH, interaction with mucosal tissues, residence time, spreading behavior, release of drug from the formulation, and other performance attributes that could affect local delivery. The FDA is specifically looking to support research that can translate these real-world use conditions into reproducible, standardized tests that help predict whether two products will perform the same way in patients. The longer-term regulatory value is that improved in vitro tools can reduce uncertainty in BE determinations and, in some cases, may reduce reliance on more burdensome clinical endpoint studies.

The award mechanism for this opportunity is a Cooperative Agreement, which generally means the FDA expects to have substantial involvement in the project beyond simply providing funds. Cooperative agreements often include collaboration, scientific input, or coordination with the agency during the project period, reflecting the fact that the resulting methods or data are intended to be directly useful for regulatory science and generic drug evaluation. The program is listed under CFDA 93.103, and it falls within research and development activities tied to consumer protection, health, and science and technology.

In terms of funding parameters, the posted award ceiling is $1,000,000. The opportunity listing shows "Expected Awards:" but does not provide a number in the supplied text, so applicants would typically check the full announcement for any additional details about the number of awards, project period, and budget structure. Key timeline details provided include a creation date of January 13, 2022, and an original closing date of March 31, 2022, indicating this specific call was tied to that application cycle.

Eligibility is broad and inclusive. Eligible applicants include higher education institutions (public/state controlled and private), nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses and other than small businesses), and a wide range of governmental entities (state, county, city/township, special district governments, tribal governments both federally recognized and other than federally recognized, and U.S. territories or possessions). The announcement also explicitly encourages applications from institutions that are often underrepresented in federal research funding, including Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). Additional eligible organization types listed include independent school districts, public housing authorities/Indian housing authorities, Native American tribal organizations (other than federally recognized tribal governments), faith-based or community-based organizations, and regional organizations.

The opportunity is also open to non-U.S. participation. Non-domestic (non-U.S.) entities and foreign institutions are eligible to apply, and non-domestic components of U.S. organizations are eligible as well. Foreign components, as defined in the HHS Grants Policy Statement, are allowed. This international eligibility signals that the FDA is interested in leveraging global scientific expertise and methodologies, as long as the work aligns with the program goals of improving BE evaluation tools for these specific topical dosage forms.

Overall, this grant opportunity is aimed at advancing regulatory science for generic rectal and vaginal topical products by building robust, biorelevant in vitro performance tests and other characterization tools that can support product sameness and BE determinations. The intended outcome is better, more reliable evidence to compare generic and reference products, which can ultimately support efficient generic development while maintaining confidence in quality, performance, and patient outcomes.

• The Food and Drug Administration in the consumer protection, health, science and technology and other research and development sector is offering a public funding opportunity titled "In Vitro Based Approaches to Evaluate the Bioequivalence of Generic Rectal and Vaginal Products" 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 2022-01-13.
• Applicants must submit their applications by 2022-03-31. (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.
• Eligible applicants include: Others.

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