Biosimilar Product Applications - 351(k)(2)(A)(i) and (k)(2)(A)(iii)

General Licensing Provisions; Section 351(k) Biosimilar Applications

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	Biosimilar Product Applications - 351(k)(2)(A)(i) and (k)(2)(A)(iii)	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

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: 5	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	5	3	2
Annual IC Time Burden (Hours)	4,300	2,580	1,720
Annual IC Cost Burden (Dollars)	0	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.