OMB control number

Biosimilar User Fee Program

OMB 0910-0718 · HHS/FDA.

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 biosimilar product marketing applications subject to statutory and regulatory requirements administered by FDA.

The latest form for Biosimilar User Fee Program expires 2028-07-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form Form FDA 3792 Biosimilar User Fee Cover Sheet (Form FDA 3792) & Annual Survey Form and Instruction
0718BiosimilarUserFeeProgramSSA2025REV.docx Supporting Statement A
Pediatric Study Plan Other-Agency Guidance
Formal Meeting Requests; Meeting Packages Other-Agency Guidance
Applications and infringement notifications Other-Agency Performance Goals
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 Form and Instruction

All Historical Document Collections

202408-0910-008	Revision of a currently approved collection	2025-01-31
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

OMB Details

Biosimilar User Fee Cover Sheet (Form FDA 3792) & Annual Survey

Federal Enterprise Architecture: Health - Health Care Services

Form Form FDA 3792

Biosimilar User Fee Cover Sheet

Fillable Fileable

Form and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.