Opportunity Information: Apply for RFA FD 23 026
The Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional (RFA-FD-23-026) is a Food and Drug Administration (FDA) discretionary funding opportunity designed to advance regulatory science and practical development tools for biosimilar and interchangeable biological products. In plain terms, the grant supports research that can make it easier, faster, more predictable, and more scientifically rigorous to develop and evaluate biosimilars and interchangeables, with an emphasis on work that can inform FDA review standards, regulatory decision-making, and modernized scientific methods used across the product lifecycle. The activity focus falls under consumer protection, science and technology, and other research and development, and it is associated with CFDA number 93.103.
The award mechanism is a cooperative agreement (U01), which typically means the FDA expects to have substantial involvement during the project rather than serving only as a passive funder. In practice, this often translates into closer coordination with the agency, potential collaboration on milestones, and regular communication to ensure the work remains aligned with regulatory science priorities. The listing indicates that clinical trials are optional, so applicants can propose either non-clinical, translational, methodological, or clinical research depending on what best addresses the scientific and regulatory gap they are targeting.
The opportunity is broadly open to a wide range of applicant organizations. Eligible applicants include public and private institutions of higher education (including public/state controlled and private universities), nonprofits both with and without 501(c)(3) status (as long as they are not higher education institutions when applying under those categories), for-profit entities (including small businesses and other for-profits), and multiple levels of government such as state, county, city or township, and special district governments. Eligibility also extends to independent school districts, public housing authorities/Indian housing authorities, federally recognized tribal governments, tribal organizations that are not federally recognized governments, and other entities such as faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) institutions. The announcement also explicitly encourages applications from certain categories of higher education 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).
In terms of funding scale, the posted award ceiling is $2,000,000, indicating the maximum amount expected per award under the terms of this announcement. The original closing date listed is April 26, 2023, and the FOA record shows a creation date of February 16, 2023. While the summary here focuses on the core purpose and eligibility, the central takeaway is that the FDA is using BsUFA-associated research funding to build better scientific evidence and tools that support biosimilar and interchangeable product development, strengthen regulatory evaluations, and ultimately improve patient access to safe and effective biologic therapies through more efficient and reliable pathways for biosimilar competition.Apply for RFA FD 23 026
- The 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 2023-02-16.
- Applicants must submit their applications by 2023-04-26. (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 $2,000,000.00 in funding.
- 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.
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Frequently Asked Questions (FAQs)
What is the BsUFA Research Grant (U01) (RFA-FD-23-026)?
The Biosimilar User Fee Act (BsUFA) Research Grant (U01), RFA-FD-23-026, is an FDA discretionary funding opportunity that supports research to advance regulatory science and practical development tools for biosimilar and interchangeable biological products.
What is the main purpose of this grant opportunity?
The purpose is to generate scientific evidence, methods, and tools that can make development and evaluation of biosimilar and interchangeable products easier, faster, more predictable, and more scientifically rigorous. The work is intended to inform FDA review standards, regulatory decision-making, and modernized scientific methods used across the product lifecycle.
What kinds of research does the FDA want to fund under this opportunity?
Based on the description, the opportunity supports regulatory science and practical development tools related to biosimilars and interchangeables. The listing notes that clinical trials are optional, so applicants may propose non-clinical, translational, methodological, or clinical research, depending on the gap being addressed.
Are clinical trials required for this grant?
No. Clinical trials are optional under this funding opportunity, meaning an application may include clinical trials or may focus entirely on non-clinical, translational, or methodological work.
What does it mean that the award mechanism is a cooperative agreement (U01)?
A U01 cooperative agreement typically indicates that the FDA expects substantial involvement during the project rather than acting only as a passive funder. In practice, this often involves closer coordination with the agency, collaboration around milestones, and regular communication to keep the project aligned with regulatory science priorities.
Who is the funding agency?
The funding agency is the U.S. Food and Drug Administration (FDA).
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.103.
What are the eligible applicant types?
Eligibility is broad and includes:
- Public institutions of higher education (including public/state controlled universities)
- Private institutions of higher education (private universities)
- Nonprofits with 501(c)(3) status (when applying under nonprofit categories, as long as they are not higher education institutions under those categories)
- Nonprofits without 501(c)(3) status (when applying under nonprofit categories, as long as they are not higher education institutions under those categories)
- For-profit organizations (including small businesses and other for-profit entities)
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public housing authorities/Indian housing authorities
- Federally recognized tribal governments
- Tribal organizations that are not federally recognized governments
- Faith-based or community-based organizations
- Regional organizations
- U.S. territories or possessions
- Non-U.S. (foreign) institutions
Are non-U.S. (foreign) institutions eligible to apply?
Yes. The eligibility list explicitly includes non-U.S. (foreign) institutions.
Are for-profit companies eligible to apply?
Yes. For-profit entities, including small businesses and other for-profits, are included as eligible applicants.
Are state and local government entities eligible?
Yes. The eligible applicant categories include state governments, county governments, city or township governments, and special district governments.
Are tribal governments and tribal organizations eligible?
Yes. Eligibility includes federally recognized tribal governments as well as tribal organizations that are not federally recognized governments.
Are public housing authorities eligible to apply?
Yes. Public housing authorities and Indian housing authorities are listed as eligible applicants.
Are community-based or faith-based organizations eligible?
Yes. The eligibility list includes other entities such as faith-based or community-based organizations.
Are minority-serving institutions encouraged to apply?
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, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).
What is the maximum funding amount (award ceiling)?
The posted award ceiling is $2,000,000, which indicates the maximum amount expected per award under the terms of this announcement.
What is the application deadline listed for this opportunity?
The original closing date listed is April 26, 2023.
When was this FOA record created?
The FOA record shows a creation date of February 16, 2023.
What topic area does this funding opportunity fall under?
The activity focus is listed under consumer protection, science and technology, and other research and development.
How does this grant relate to biosimilars and interchangeable biological products?
The grant is intended to support research that strengthens the scientific foundation and practical tools used to develop and evaluate biosimilars and interchangeables. The emphasis is on work that can inform FDA regulatory standards and decisions and modernize scientific methods used across the product lifecycle.
What outcomes is the FDA trying to achieve through this BsUFA-associated research funding?
The central aim is to build better scientific evidence and tools that support biosimilar and interchangeable product development and strengthen regulatory evaluations, which is intended to improve patient access to safe and effective biologic therapies by enabling more efficient and reliable pathways for biosimilar competition.
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