Biosimilar User Fee Program

OMB 0910-0718

This information collection supports the Food and Drug Administration’s (FDA, us or we) Biosimilars User Fee Program. Respondents to the collection are applicants or sponsors of biological product applications.

The latest form for Biosimilar User Fee Program expires 2021-12-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Formal Meeting Requests; Meeting Packages Other-Agency Guidance
Applications and infringement notifications Other-FDA Reauthorization Act
Requests for discontinuation from BPD program and /or to move products to discontinued section. Other-Agency Guidance
Biosimilar User Fee Cover Sheet (Form FDA 3792) & Annual Survey Other-Survey

All Historical Document Collections

202112-0910-007 Approved without change	Revision of a currently approved collection	2021-12-23
201805-0910-004 Approved without change	Revision of a currently approved collection	2018-12-06
201801-0910-002 Approved without change	No material or nonsubstantive change to a currently approved collection	2018-01-04
201708-0910-005 Approved without change	No material or nonsubstantive change to a currently approved collection	2017-08-08
201608-0910-005 Approved without change	No material or nonsubstantive change to a currently approved collection	2016-08-04
201506-0910-013 Approved without change	Extension without change of a currently approved collection	2015-06-23
201206-0910-008 Approved with change	New collection (Request for a new OMB Control Number)	2012-06-20