Information Collection

FDA Biosimilar User Fee Program

IC 202806 under ICR 201805-0910-004 · OMB 0910-0718.

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Documents and Forms

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IC Title:

FDA Biosimilar User Fee Program

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

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

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 35

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
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	77	42	35
Annual IC Time Burden (Hours)	57	-3	60
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

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