Opportunity Information: Apply for RFA FD 23 013
This grant opportunity, titled "Evaluation of oral modified release drug tablet to support the approval of additional strengths" (RFA FD 23 013), is a Food and Drug Administration (FDA) research funding announcement under the U.S. Department of Health and Human Services. It is aimed at improving the scientific basis and practical approach for approving additional strengths of oral modified-release tablets in the generic drug context, particularly for products submitted through an Abbreviated New Drug Application (ANDA). The award mechanism is a cooperative agreement, which typically means the FDA expects to have substantial involvement during the project, such as participating in technical discussions, aligning on research directions, and helping ensure the work addresses regulatory needs.
The core problem the opportunity addresses comes from how companies demonstrate that multiple strengths of a modified-release tablet (for example, 5 mg, 10 mg, 20 mg) behave the same way in the body and are manufactured in a way that preserves the intended release behavior. The FDA guidance document "Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA" (August 2021) lays out recommendations for showing bioequivalence for additional strengths, especially when it may not be feasible or necessary to run full in vivo bioequivalence studies for every strength. For modified-release products, the FDA places strong emphasis on evidence that all strengths share the same drug release mechanism, have similar dissolution profiles across strengths, and maintain excipient ratios that make sense for the release-controlling design. In practice, the challenge is that modified-release tablets can use different platform technologies (such as hydrophilic matrix systems, osmotic systems, coated multiparticulates compressed into tablets, or other release-controlling architectures), and the rules for what can be safely "scaled" from one strength to another are not always straightforward.
The purpose of the funded project is to identify the critical quality attributes (CQAs) that matter most for different modified-release platform technologies and to determine what formulation and process scaling factors are appropriate when developing additional strengths. CQAs are the measurable physical, chemical, biological, or microbiological properties that need to be within certain limits to ensure product quality and performance. In the modified-release tablet setting, this often ties directly to how the dosage form controls drug release over time. The research is intended to clarify which attributes and formulation relationships are essential to preserving the same release mechanism across strengths, and which changes are acceptable when strength is increased or decreased. That includes, but is not limited to, understanding how excipient-to-drug ratios should be adjusted (or held constant) depending on the technology, and how changes in tablet size, surface area, coating weight gain, polymer content, porosity, or other structural variables can alter dissolution behavior.
The expected outcome is practical knowledge that can be used both by generic drug developers and by FDA reviewers making regulatory decisions. For generic manufacturers, clearer evidence-based scaling principles can reduce development uncertainty, lower the risk of late-stage failure, and help determine when in vivo bioequivalence testing can be reduced or replaced by strong in vitro and formulation-bridging evidence. For regulators, the work is meant to strengthen the scientific foundation behind decisions on whether additional strengths can be approved based on similarity of release mechanism and dissolution, rather than requiring extensive clinical pharmacokinetic studies for each strength. In other words, the project supports the broader goal of making generic development more efficient while still protecting patients by ensuring consistent performance across strengths.
Administratively, this is a discretionary funding opportunity categorized under consumer protection, science and technology, and other research and development. It is listed under CFDA number 93.103. The opportunity was created on December 1, 2022, with an original application closing date of March 15, 2023. The award ceiling is $450,000, and the FDA anticipated making one award, which suggests a single research team or consortium would be selected to carry out the work, likely producing outputs that could influence future guidance interpretation, review practices, or publicly shared scientific recommendations.
Eligibility is broad and includes many types of organizations that can conduct applied pharmaceutical science research. Eligible applicants include state, county, and local governments; public and private institutions of higher education; Native American tribal governments and organizations; public housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (including those other than small businesses); small businesses; and other entities as described in the eligibility clarification text. This wide eligibility list indicates the FDA is primarily focused on obtaining high-quality, relevant research results, regardless of whether the performer is an academic lab, a nonprofit research institute, a private company with specialized formulation expertise, or a multi-organization partnership.
Overall, the grant is best understood as targeted regulatory science: it is not simply basic research on drug delivery, but a project designed to produce concrete, decision-relevant evidence on how to scale modified-release tablet formulations across strengths while maintaining the same release-controlling mechanism and comparable dissolution behavior. The intended impact is improved consistency, predictability, and scientific rigor in demonstrating bioequivalence for additional strengths of generic modified-release oral dosage forms, ultimately supporting both efficient generic competition and robust assurance of therapeutic equivalence.Apply for RFA FD 23 013
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, science and technology and other research and development sector is offering a public funding opportunity titled "Evaluation of oral modified release drug tablet to support the approval of additional strengths" 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 01, 2022.
- Applicants must submit their applications by Mar 15, 2023. (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 $450,000.00 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, Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is the title and identifier of this grant opportunity?
The opportunity is titled "Evaluation of oral modified release drug tablet to support the approval of additional strengths" and is identified as RFA FD 23 013.
Which federal agency is offering this funding?
The funding announcement is from the Food and Drug Administration (FDA) under the U.S. Department of Health and Human Services (HHS).
What is the main purpose of the project funded by this opportunity?
The purpose is to improve the scientific basis and practical approach used to support approval of additional strengths of oral modified-release tablets in the generic drug setting, particularly for products submitted through an Abbreviated New Drug Application (ANDA).
What problem is the FDA trying to address with this research?
The opportunity targets a common development and review challenge: demonstrating that multiple strengths of a modified-release tablet (for example, 5 mg, 10 mg, 20 mg) share the same release mechanism, have similar dissolution behavior across strengths, and are manufactured in ways that preserve the intended modified-release performance.
How does this relate to ANDA submissions for generic drugs?
The work is intended to generate decision-relevant evidence that can be used in the ANDA context, especially where a sponsor seeks approval of multiple strengths and wants to justify when full in vivo bioequivalence (BE) studies may not be needed for every strength.
What FDA guidance is referenced in the announcement?
The announcement references the FDA guidance document "Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA" (August 2021), which provides recommendations for demonstrating bioequivalence, including considerations for additional strengths.
What does "oral modified-release tablet" mean in the context of this funding?
It refers to an oral tablet designed to release drug over time (rather than immediately), using a release-controlling design. The grant focuses on how those designs behave when the product is offered in multiple strengths.
Why are additional strengths of modified-release tablets challenging to justify?
Modified-release tablets can rely on different platform technologies and structural variables, so scaling from one strength to another is not always straightforward. Changes in formulation ratios, tablet geometry, coatings, or internal structure can unintentionally change how the drug is released, which in turn can affect dissolution behavior and performance.
What types of modified-release platform technologies are mentioned?
The description mentions several examples, including hydrophilic matrix systems, osmotic systems, and coated multiparticulates compressed into tablets, as well as other release-controlling architectures.
What are Critical Quality Attributes (CQAs), and why are they central to this project?
CQAs are measurable properties (physical, chemical, biological, or microbiological) that must stay within appropriate limits to ensure product quality and performance. For modified-release tablets, CQAs often directly relate to the dosage form's release-controlling function and the resulting dissolution profile over time.
What specific research questions is the project expected to answer?
Based on the announcement, the research is expected to identify the CQAs that matter most for different modified-release platform technologies and determine appropriate formulation and process scaling factors for developing additional strengths while preserving the same release mechanism and comparable dissolution behavior.
What kinds of formulation or process variables are explicitly called out as important?
The announcement highlights variables such as excipient-to-drug ratios, tablet size, surface area, coating weight gain, polymer content, porosity, and other structural variables that may alter dissolution behavior and the release mechanism when strengths change.
What does the FDA want to learn about excipient-to-drug ratios across strengths?
The work is intended to clarify when excipient-to-drug ratios should be adjusted versus held constant, depending on the modified-release technology and what is essential to maintaining the same release-controlling mechanism across strengths.
What is meant by "scaling principles" for additional strengths?
In this context, scaling principles refer to evidence-based rules or factors that explain how a modified-release tablet formulation and manufacturing process can be increased or decreased in strength while maintaining the same release mechanism and similar dissolution profiles.
What outcomes does the FDA expect from the funded research?
The expected outcome is practical, usable knowledge for both generic drug developers and FDA reviewers. The intent is to strengthen the scientific foundation for decisions on approving additional strengths based on release-mechanism similarity and dissolution evidence, rather than routinely requiring extensive clinical pharmacokinetic studies for each strength.
How could this project affect in vivo bioequivalence study expectations for additional strengths?
The announcement indicates that clearer scaling and CQA-based principles may help determine when in vivo bioequivalence testing for every strength can be reduced or potentially replaced by strong in vitro and formulation-bridging evidence, while still supporting consistent performance across strengths.
What is the award mechanism, and what does it imply about FDA involvement?
The award mechanism is a cooperative agreement. This typically implies substantial FDA involvement during the project, such as participation in technical discussions, alignment on research directions, and helping ensure the research addresses regulatory needs.
How is this opportunity categorized administratively?
It is described as discretionary funding and is categorized under consumer protection, science and technology, and other research and development.
What is the CFDA number for this funding opportunity?
The CFDA number listed is 93.103.
What was the application timeline provided in the announcement?
The opportunity was created on December 1, 2022, and the original application closing date was March 15, 2023.
What is the maximum funding amount available (award ceiling)?
The award ceiling is $450,000.
How many awards did the FDA anticipate making?
The FDA anticipated making one award, suggesting a single research team or consortium would be selected.
Who is eligible to apply for this grant?
Eligibility is broad and includes state, county, and local governments; public and private institutions of higher education; Native American tribal governments and organizations; public housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (including those other than small businesses); small businesses; and other entities described in the eligibility clarification text.
Is this opportunity limited to academic institutions?
No. The eligibility list includes academic institutions, nonprofits, for-profits, small businesses, governments, and other eligible entities, indicating the FDA is focused on obtaining high-quality, relevant applied research results regardless of organizational type.
Is this grant focused on basic drug delivery research or regulatory science?
The description frames this as targeted regulatory science. The goal is not simply basic research, but producing concrete, decision-relevant evidence that supports regulatory evaluation of additional strengths for generic modified-release oral tablets.
How might the results be used by FDA reviewers?
The results are intended to inform regulatory decisions about whether additional strengths can be approved based on similarity of release mechanism and dissolution, and to strengthen the scientific basis behind those determinations.
How might the results help generic drug developers?
The announcement indicates that clearer, evidence-based scaling principles can reduce development uncertainty, lower the risk of late-stage failure, and help developers plan efficient strategies for demonstrating bioequivalence across strengths.
What is the broader public health or market impact described for this work?
The work supports more efficient generic development while protecting patients by ensuring consistent performance across strengths. It is also positioned to support efficient generic competition while maintaining robust assurance of therapeutic equivalence.
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