FDA Biosimilar User Fee Act Research Grant (U01) Clinical Trials Optional

The FDA is offering the Biosimilar User Fee Act Research Grant to support research in the field of biosimilars. This grant aims to encourage innovative studies and advancements in biosimilar development. Researchers have the opportunity to apply for this grant until May 09, 2022, to contribute to the improvement and efficiency of biosimilar products under the BsUFA framework.

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::
Category of Funding Activity::	Consumer Protection
Category Explanation::
Expected Number of Awards::	5
Assistance Listings Number(s)::	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

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::
Link to Additional Information::
Grantor Contact Information::	If you have difficulty accessing the full announcement electronically, please contact:

Version History

Assistance Listings:	93.103
Competition ID:	RFA-FD-22-026
Competition Title:	FORMS G
Opportunity Package ID:	PKG00272396
Opening Date:	Mar 08, 2022
Closing Date:	May 09, 2022
Agency Contact Information::	Shashi Malhotra
Who Can Apply::	Organization Applicants
mendatory_forms	SF424 (R & R) [V5.0] PHS 398 Cover Page Supplement [V5.0] Research And Related Other Project Information [V1.4] Project/Performance Site Location(s) [V4.0] Research and Related Senior/Key Person Profile (Expanded) [V4.0] Research & Related Budget [V3.0] PHS 398 Research Plan [V4.0] PHS Human Subjects and Clinical Trials Information [V3.0]
optional_forms	R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V3.0] PHS Assignment Request Form [V3.0]

FDA Biosimilar User Fee Act Research Grant (U01) Clinical Trials Optional

General Information

Eligibility

Additional Information

Version History

Package Status

Packages