Information Collection

Prescription Drug User Fee Cover Sheet

IC 5861 under ICR 202407-0910-006 · OMB 0910-0297.

Documents and Forms

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

IC Title:

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:

table that charts list of instruments
Document Type	Form No.	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-E-form Screenshot		Yes	Yes	Fillable Fileable
Instruction		Yes	Yes	Fillable Fileable
Form	Form FDA 3397	Yes	Yes	Fillable Fileable
Other-PDUFA VII Commitment Letter		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 %

table that charts list of burden
	Approved	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

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.

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