Form FDA 3792

Biosimilar User Fee Cover Sheet - Form FDA 3792

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0718 can be found here:

Documents and Forms

Document Name Document Type
Form Form FDA 3792 Form FDA 3792 Form and Instruction
Form FDA 3792 Biosimilar User Fee Cover Sheet FORM FDA 3792 BSUFA User Fee Cover Sheet.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Form FDA 3792	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	Form FDA 3792	Biosimilar User Fee Cover Sheet	FORM FDA 3792 BSUFA User Fee Cover Sheet.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 20	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Previously Approved
Annual Number of Responses for this IC	20	20
Annual IC Time Burden (Hours)	10	10
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.