Opportunity Information: Apply for RFA FD 22 026
The Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional (Funding Opportunity Number RFA-FD-22-026) is a discretionary federal funding opportunity from the U.S. Department of Health and Human Services (HHS), administered by the Food and Drug Administration (FDA). It is structured as a cooperative agreement (U01), which generally means the FDA expects to have substantial scientific or programmatic involvement during the life of the project rather than acting solely as a passive funder. The core goal of the announcement is to fund research that strengthens biosimilar and interchangeable biological product development and advances regulatory science in ways that can support FDA decision-making and improve the efficiency, predictability, and scientific foundation of biosimilar pathways.
This FOA focuses on biosimilars and interchangeables, which are biological products developed to be highly similar to, or in certain cases interchangeable with, an FDA-licensed reference product. Because biologics are typically large, complex molecules made in living systems, demonstrating biosimilarity relies on a totality-of-evidence approach that integrates advanced analytical characterization, functional data, nonclinical and clinical information (as needed), and rigorous assessment of residual uncertainty. The research supported under this opportunity is intended to generate practical scientific evidence, tools, or methodologies that can help developers and regulators evaluate biosimilarity and interchangeability more effectively, including approaches that may reduce unnecessary development burdens while maintaining high standards for safety, purity, and potency.
The “clinical trials optional” designation signals that proposed projects may include clinical trials but are not required to do so. In practice, that opens the door for a wide range of study designs, from purely laboratory and computational work (such as analytical methods, modeling, or novel comparability frameworks) to human-subject research where it is justified by the scientific question. The emphasis is on research that has clear relevance to biosimilar regulatory science, meaning it should be positioned to inform development strategies, regulatory evaluation, or post-approval considerations tied to biosimilar and interchangeable products.
Eligibility is broad and includes multiple types of domestic organizations and governmental entities. Eligible applicants listed include state, county, and city or township 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and additional entities as described in the announcement’s eligibility clarification field. This wide eligibility range is consistent with FDA regulatory science funding, which often seeks participation from academia, government labs, nonprofit research groups, and industry or industry-adjacent organizations when appropriate.
The funding instrument is a cooperative agreement, and that matters for applicants because it typically involves closer coordination with FDA staff across the project period. Applicants should generally expect that FDA may collaborate on aspects such as refining aims to align with regulatory science needs, advising on study design elements that affect regulatory relevance, coordinating access to certain resources or expertise, or ensuring deliverables are usable in a regulatory context. While the specific terms vary by award, the U01 structure usually implies planned interaction and shared stewardship of milestones rather than a hands-off grant relationship.
Key administrative details from the source data include a creation date of March 4, 2022, with an original closing date of May 9, 2022. The opportunity lists an award ceiling of $1,000,000 and anticipates making about 5 awards. The assistance listing is tied to CFDA number 93.103, and the activity category is described broadly as consumer protection, science and technology, and other research and development. Taken together, these details suggest a relatively competitive, targeted program designed to fund a small number of projects with meaningful potential impact on FDA’s biosimilar and interchangeable product scientific framework.
In summary, this FOA is aimed at funding high-value regulatory science research that can directly improve how biosimilars and interchangeables are developed and evaluated in the United States. Successful projects are likely to be those that identify concrete scientific gaps or recurring regulatory challenges in biosimilar development, propose credible methods to address them, and produce outputs that are usable beyond a single product program, such as validated methods, datasets, models, or generalizable evidence that can strengthen the overall biosimilar regulatory ecosystem.Apply for RFA FD 22 026
- 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 "Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional" 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 Mar 04, 2022.
- Applicants must submit their applications by May 09, 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 $1,000,000.00 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, 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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| Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required Apply for FOR FD 23 007 Funding Number: FOR FD 23 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $650,000 |
| Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models Apply for RFA FD 23 016 Funding Number: RFA FD 23 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $500,000 |
| Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed Apply for RFA FD 23 012 Funding Number: RFA FD 23 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $1,200,000 |
| Evaluation of oral modified release drug tablet to support the approval of additional strengths Apply for RFA FD 23 013 Funding Number: RFA FD 23 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $450,000 |
| Novel approaches to support therapeutic development in ultra-rare cancers Apply for RFA FD 23 008 Funding Number: RFA FD 23 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,500,000 |
| In Vitro Based Approaches to Evaluate the Bioequivalence of Prospective Generic Rectal and Vaginal Products (U01) Clinical Trial Not Allowed Apply for RFA FD 23 014 Funding Number: RFA FD 23 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Applied Regulatory Science Research to Understand Factors that Affect the Safety and Efficacy of Underrepresented Populations in Oncology Therapeutic Development (U01) Clinical Trial Optional Apply for RFA FD 23 006 Funding Number: RFA FD 23 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,500,000 |
| Site Selection in Oncology Clinical Trials: Considerations for Selecting Sites in Limited Geographic Regions or Areas of Political Unrest, Limiting Inspection Capabilities (U13) Clinical Trial not allowed. Apply for RFA FD 23 007 Funding Number: RFA FD 23 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $300,000 |
| Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional Apply for RFA FD 23 015 Funding Number: RFA FD 23 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $750,000 |
| Pediatric Device Consortia Grants Program (P50) Clinical Trials Optional Apply for RFA FD 23 024 Funding Number: RFA FD 23 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $5,000,000 |
| Natural History and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional Apply for RFA FD 23 028 Funding Number: RFA FD 23 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,000,000 |
| Education and Training Program for Outsourcing Facility Industry (UE5) Clinical Trials Not Allowed Apply for RFA FD 23 029 Funding Number: RFA FD 23 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $5,500,000 |
| Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required Apply for RFA FD 23 001 Funding Number: RFA FD 23 001 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $650,000 |
| Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed Apply for RFA FD 23 017 Funding Number: RFA FD 23 017 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $500,000 |
| Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional Apply for RFA FD 23 026 Funding Number: RFA FD 23 026 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,000,000 |
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