Information Collection

Applications and infringement notifications

IC 250903 under ICR 202408-0910-008 · OMB 0910-0718.

Documents and Forms

Documents and forms in this information collection
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

IC Title:

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:

table that charts list of 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 %

table that charts list of burden
	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

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.