Information Collection

Prescription Drug User Fee Cover Sheet; Form FDA 3397

IC 5861 under ICR 201211-0910-001 · 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⚠️ Notice: This information collection may be referencing outdated material.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

Documents and forms in this information collection
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 10-5-12.pdf	Form and Instruction

IC Title:

Prescription Drug User Fee Cover Sheet; Form FDA 3397

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

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
Form and Instruction	3397	Prescription Drug User Fee Cover Sheet	PDUFA FORM FDA 3397 10-5-12.pdf		Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 260

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 15 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	4,131	214	3,917
Annual IC Time Burden (Hours)	2,066	107	1,959
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.