OMB.report

Federal forms, ICRs, and supporting documents

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 is listed under ICR 202408-0910-008.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form Form FDA 3792 Biosimilar User Fee Cover Sheet (Form FDA 3792) & Annual SurveyForm and Instruction
0718BiosimilarUserFeeProgramSSA2025REV.docxSupporting 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All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202408-0910-008 Revision of a currently approved collection 2025-01-31
202112-0910-007 Revision of a currently approved collection 2021-12-23 Approved without change
201805-0910-004 Revision of a currently approved collection 2018-12-06 Approved without change
201801-0910-002 No material or nonsubstantive change to a currently approved collection 2018-01-04 Approved without change
201708-0910-005 No material or nonsubstantive change to a currently approved collection 2017-08-08 Approved without change
201608-0910-005 No material or nonsubstantive change to a currently approved collection 2016-08-04 Approved without change
201506-0910-013 Extension without change of a currently approved collection 2015-06-23 Approved without change
201206-0910-008 New collection (Request for a new OMB Control Number) 2012-06-20 Approved with change

OMB Details

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

Federal Enterprise Architecture: Health - Health Care Services

Information collection instruments
FormNameElectronic accessType
Form Form FDA 3792Biosimilar User Fee Cover SheetFillable FileableForm and instruction

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