Prescription Drug User Fee Cover Sheet

Prescription Drug User Fee Program

Documents and Forms

Document Name Document Type
PDUFA Cover Screenshot Feb 2019.pdf Other-E-form Screenshot
PDUFA Step by Step Instructions 2025.pdf Instruction
Form FDA 3397 Prescription Drug User Fee Cover Sheet PDUFA FORM FDA 3397 10-5-12 (4).pdf Form
PDUFA VII - Commitment Letter - 08192021.pdf Other-PDUFA VII Commitment Letter

Information Collection (IC) Details

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

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	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-E-form Screenshot			PDUFA Cover Screenshot Feb 2019.pdf	Yes	Yes	Fillable Fileable
Instruction			PDUFA Step by Step Instructions 2025.pdf	Yes	Yes	Fillable Fileable
Form	Form FDA 3397	Prescription Drug User Fee Cover Sheet	PDUFA FORM FDA 3397 10-5-12 (4).pdf	Yes	Yes	Fillable Fileable
Other-PDUFA VII Commitment Letter			PDUFA VII - Commitment Letter - 08192021.pdf	Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 132	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	164	-10	174
Annual IC Time Burden (Hours)	82	-5	87
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.