Information Collection

Application for Biosimilars - 351(k)(2)(B) and (k)(4)

IC 202639 under ICR 201206-0910-004 · OMB 0910-0719.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0719 can be found here:

Documents and Forms

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Information Collection (IC) Details

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IC Title:	Application for Biosimilars - 351(k)(2)(B) and (k)(4)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 601.2(a) and 601.60-601.65

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Illness Prevention

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	1	1
Annual IC Time Burden (Hours)	860	860
Annual IC Cost Burden (Dollars)	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.