Information Collection

Prescription Drug User Fee Cover Sheet; Form FDA 3397

IC 5861 under ICR 201708-0910-004 · 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⚠️ Notice: This information collection may be referencing outdated material.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
Form 3397 Prescription Drug User Fee Cover Sheet; Form FDA 3397 Form and Instruction
3397 Prescription Drug User Fee Cover Sheet PDUFA FORM FDA 3397 7-28-2015.pdf Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Prescription Drug User Fee Cover Sheet; Form FDA 3397	Agency IC Tracking Number:	CBER

Is this a Common Form? No		IC Status: Unchanged

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
Form and Instruction	3397	Prescription Drug User Fee Cover Sheet	PDUFA FORM FDA 3397 7-28-2015.pdf		Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 290	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	Previously Approved
Annual Number of Responses for this IC	3,709	3,709
Annual IC Time Burden (Hours)	1,855	1,855
Annual IC Cost Burden (Dollars)	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.