The FDA is offering the Biosimilar User Fee Act (BsUFA) Research Grant to advance biosimilar and interchangeable biological product development and regulatory science.

The Food and Drug Administration (FDA) is offering the Biosimilar User Fee Act (BsUFA) Research Grant to support vital research projects. This grant is specifically designed to enhance the development of biosimilar and interchangeable biological products. By fostering advancements in regulatory science, this initiative aims to facilitate the efficient approval and availability of safe, effective, and affordable biosimilar medicines for patients. This grant is for the purpose of strengthening the scientific basis for regulatory decision-making concerning biosimilars. The program targets studies providing crucial insights and methodologies for evaluating the similarity, safety, and efficacy of biosimilars against reference products. Ultimately, this funding seeks to improve the regulatory pathway, ensuring high-quality biosimilars reach the market and increase patient access to critical biological therapies. The FDA encourages research addressing current challenges in product development and regulatory assessment.

Opportunity ID: 338326

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General Information

Document Type:	Grants Notice
Funding Opportunity Number:	RFA-FD-22-026
Funding Opportunity Title:	Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional
Opportunity Category:	Discretionary
Opportunity Category Explanation:	–
Funding Instrument Type:	Cooperative Agreement
Category of Funding Activity:	Consumer Protection Science and Technology and other Research and Development
Category Explanation:	–
Expected Number of Awards:	5
Assistance Listings:	93.103 — Food and Drug Administration Research
Cost Sharing or Matching Requirement:	No
Version:	Synopsis 1
Posted Date:	Mar 04, 2022
Last Updated Date:	Mar 04, 2022
Original Closing Date for Applications:	May 09, 2022
Current Closing Date for Applications:	May 09, 2022
Archive Date:	Jun 08, 2022
Estimated Total Program Funding:	–
Award Ceiling:	$1,000,000
Award Floor:	$50,000

Eligibility

Eligible Applicants:

Independent school districts
Special district governments
City or township governments
Private institutions of higher education
Public and State controlled institutions of higher education
County governments
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
For profit organizations other than small businesses
State governments
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Small businesses

Additional Information on Eligibility:

1. Eligible Applicants
Eligible Organizations
Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:

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)
Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)
Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
U.S. Territory or Possession
Other

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
Regional Organizations
Non-domestic (non-U.S) Entities (Foreign Institutions)

Additional Information

Agency Name:	Food and Drug Administration
Description:	The purpose of this Funding Opportunity Announcement (FOA) is to support research projects that enhance biosimilar and interchangeable biological product development and regulatory science.
Link to Additional Information:	Full Announcement
Grantor Contact Information:	If you have difficulty accessing the full announcement electronically, please contact: Shashi Malhotra Grants Management Specialist Phone 2404027592 Email:shashi.malhotra@fda.hhs.gov

Version History

Version	Modification Description	Updated Date

Packages

Agency Contact Information:	Shashi Malhotra Grants Management Specialist Phone 2404027592 Email: shashi.malhotra@fda.hhs.gov
Who Can Apply:	Organization Applicants

Assistance Listing Number	Competition ID	Competition Title	Opportunity Package ID	Opening Date	Closing Date	Actions
93.103	RFA-FD-22-026	FORMS G	PKG00272396	Mar 08, 2022	May 09, 2022	View

Package 1

Mandatory forms

338326 RR_SF424_5_0-5.0.pdf

338326 PHS398_CoverPageSupplement_5_0-5.0.pdf

338326 RR_OtherProjectInfo_1_4-1.4.pdf

338326 PerformanceSite_4_0-4.0.pdf

338326 RR_KeyPersonExpanded_4_0-4.0.pdf

338326 RR_Budget_3_0-3.0.pdf

338326 PHS398_ResearchPlan_4_0-4.0.pdf

338326 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf

Optional forms

338326 RR_SubawardBudget30_3_0-3.0.pdf

338326 PHS_AssignmentRequestForm_3_0-3.0.pdf

osnqt2025-07-12T14:16:39-05:00

The FDA is offering the Biosimilar User Fee Act (BsUFA) Research Grant to advance biosimilar and interchangeable biological product development and regulatory science.

General Information

Eligibility

Additional Information

Version History

Related Documents

Packages

Package 1

Mandatory forms

Optional forms

About the Author: osnqt

The FDA is offering the Biosimilar User Fee Act (BsUFA) Research Grant to advance biosimilar and interchangeable biological product development and regulatory science.

General Information

Eligibility

Additional Information

Version History

Related Documents

Packages

Package 1

Mandatory forms

Optional forms

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About the Author: osnqt