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.Apply for RFA FD 22 014
- 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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FAQs: FDA Grant - In Vitro Based Approaches to Evaluate the Bioequivalence of Generic Rectal and Vaginal Products (RFA-FD-22-014)
What is the title of this FDA grant opportunity?
The opportunity is titled "In Vitro Based Approaches to Evaluate the Bioequivalence of Generic Rectal and Vaginal Products."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-FD-22-014.
What is the main purpose of this grant program?
This is a discretionary research and development program intended to improve how bioequivalence (BE) is evaluated for generic rectal and vaginal topical drug products. The focus is on clarifying the scientific and technical issues that make BE assessment for these products distinct from other dosage forms.
Why is bioequivalence evaluation especially challenging for rectal and vaginal products?
Rectal and vaginal products often act locally rather than systemically, and their performance can be influenced by formulation behavior, anatomy, physiology, and product application conditions. Because of these factors, traditional BE approaches can be difficult, expensive, or not always the most informative for determining whether a proposed generic performs the same as the reference product.
What types of research does FDA want to fund under this opportunity?
The opportunity emphasizes developing biorelevant performance tests and other in vitro approaches that reflect real-world use conditions for rectal and vaginal topical products. The aim is to create reproducible, standardized laboratory tests that help predict whether two products will perform similarly in patients.
What does "in vitro based approaches" mean in the context of this opportunity?
In this context, "in vitro based approaches" refers to laboratory testing methods (rather than clinical endpoint studies) that evaluate product performance under conditions designed to mimic the environment and use of rectal and vaginal products.
What are "biorelevant performance tests"?
Biorelevant performance tests are in vitro tests designed to realistically mimic the conditions a product experiences during use. For rectal and vaginal products, this can include simulating the relevant environment and factors that may affect local drug delivery and product behavior.
What real-world factors might these tests try to mimic?
The description highlights conditions such as fluid volumes, pH, interaction with mucosal tissues, residence time, spreading behavior, drug release from the formulation, and other performance attributes that could influence local delivery.
What is the longer-term regulatory goal of developing these in vitro tools?
The longer-term value is to improve the reliability and predictiveness of methods used to compare generic and reference products. Stronger in vitro tools can reduce uncertainty in BE determinations and, in some cases, may reduce reliance on more burdensome clinical endpoint studies.
What award mechanism is used for this grant?
The award mechanism is a Cooperative Agreement.
What does it mean that this is a Cooperative Agreement?
A Cooperative Agreement generally means FDA expects substantial involvement in the project beyond providing funds. This can include collaboration, scientific input, or coordination during the project period, reflecting that the resulting methods or data are intended to be directly useful for regulatory science and generic drug evaluation.
What is the CFDA number for this program?
The program is listed under CFDA 93.103.
What is the maximum funding amount available (award ceiling)?
The posted award ceiling is $1,000,000.
How many awards does FDA expect to make?
The listing shows "Expected Awards:" but the provided text does not include a number. Applicants would typically need to review the full announcement for details on the number of awards.
When was this funding opportunity created?
The creation date provided is January 13, 2022.
What was the closing date for applications in the described cycle?
The original closing date provided is March 31, 2022, indicating this specific call was tied to that application cycle.
Who is eligible to apply?
Eligibility is broad. 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 many governmental entities (state, county, city/township, special district governments, tribal governments, and U.S. territories or possessions). The announcement also lists additional eligible types such as 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.
Are tribal entities eligible?
Yes. Eligibility includes tribal governments (federally recognized and other than federally recognized), as well as Native American tribal organizations (other than federally recognized tribal governments).
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are listed as eligible governmental applicants.
Are for-profit organizations and small businesses eligible?
Yes. For-profit organizations are eligible, including small businesses and organizations other than small businesses.
Are nonprofits required to have 501(c)(3) status to apply?
No. Nonprofits with or without 501(c)(3) status are listed as eligible.
Does FDA encourage applications from underrepresented institutions?
Yes. The announcement 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, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), and others listed in the opportunity description.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. Non-domestic (non-U.S.) entities and foreign institutions are eligible to apply.
Can a U.S. organization include work performed outside the United States?
Yes. Non-domestic components of U.S. organizations are eligible, and foreign components (as defined in the HHS Grants Policy Statement) are allowed.
What kinds of outcomes is FDA trying to achieve through this funding?
The intended outcome is to advance regulatory science for generic rectal and vaginal topical products by developing robust, biorelevant in vitro performance tests and related characterization tools. These tools are meant to support determinations of product sameness and bioequivalence between generic and reference products, supporting efficient generic development while maintaining confidence in quality, performance, and patient outcomes.
How does this opportunity relate to consumer protection and public health?
The program is described as research and development tied to consumer protection, health, and science and technology, with the goal of improving the evidence base used to evaluate generic products that patients rely on.
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| Development of advanced analytical methods for the characterization of complex generics Apply for RFA FD 22 013 Funding Number: RFA FD 22 013 Agency: Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $300,000 |
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