Information Collection

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

IC 202806 under ICR 202408-0910-008 · OMB 0910-0718.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form Form FDA 3792 Biosimilar User Fee Cover Sheet (Form FDA 3792) & Annual Survey	Form and Instruction
Form FDA 3792 Biosimilar User Fee Cover Sheet FORM FDA 3792 BSUFA User Fee Cover Sheet.pdf	Form and Instruction

IC Title:

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

table that charts list of 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: 30

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	60	-60	120
Annual IC Time Burden (Hours)	30	-60	90
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
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.