Opportunity ID: 345035

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-FD-23-026
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:
Assistance Listings: 93.103 — Food and Drug Administration Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 1
Posted Date: Feb 16, 2023
Last Updated Date: Feb 16, 2023
Original Closing Date for Applications: Apr 26, 2023
Current Closing Date for Applications: Apr 26, 2023
Archive Date: May 26, 2023
Estimated Total Program Funding:
Award Ceiling: $2,000,000
Award Floor: $50,000

Eligibility

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

Folder 345035 Full Announcement-RFA-FD-23-026 -> FINAL- RFA-FD-23-026.pdf

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-23-026 FORMS H PKG00279960 Feb 16, 2023 Apr 26, 2023 View

Package 1

Mandatory forms

345035 RR_SF424_5_0-5.0.pdf

345035 PHS398_CoverPageSupplement_5_0-5.0.pdf

345035 RR_OtherProjectInfo_1_4-1.4.pdf

345035 PerformanceSite_4_0-4.0.pdf

345035 RR_KeyPersonExpanded_4_0-4.0.pdf

345035 RR_Budget_3_0-3.0.pdf

345035 PHS398_ResearchPlan_5_0-5.0.pdf

345035 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf

Optional forms

345035 RR_SubawardBudget30_3_0-3.0.pdf

345035 PHS_AssignmentRequestForm_3_0-3.0.pdf

2025-07-14T07:13:53-05:00

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