Applications and infringement notifications

Biosimilar User Fee Program

Documents and Forms

Document Name Document Type
Biosimilar-Biological-Product-Reauthorization-Performance-Goals-and-Procedures-Fiscal-Years-2018-Through-2022-PDF (1).pdf Other-Agency Performance Goals
FDARA 2017.pdf Other-FDA Reauthorization Act

Information Collection (IC) Details

IC Title:	Applications and infringement notifications	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Performance Goals			Biosimilar-Biological-Product-Reauthorization-Performance-Goals-and-Procedures-Fiscal-Years-2018-Through-2022-PDF (1).pdf		Yes	Yes	Fillable Fileable
Other-FDA Reauthorization Act			FDARA 2017.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 16	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	31	11	20
Annual IC Time Burden (Hours)	18,938	9,460	9,478
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.