Information Collection

Prescription Drug User Fee Cover Sheet

IC 5861 under ICR 201902-0910-014 · OMB 0910-0297.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0297 can be found here:

Documents and Forms

Document Name Document Type
PDUFA Cover Screenshot Feb 2019.pdf userfees.fda.gov/OA_HTML/pdufaCAcdLogin.jsp Other-E-form Screenshot

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Prescription Drug User Fee Cover Sheet	Agency IC Tracking Number:	CBER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-E-form Screenshot			PDUFA Cover Screenshot Feb 2019.pdf	https://userfees.fda.gov/OA_HTML/pdufaCAcdLogin.jsp	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 155	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	262	-3,447	3,709
Annual IC Time Burden (Hours)	131	-1,724	1,855
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.