Information Collection

User Fee Cover Sheet; Form FDA 3397

IC 5861 under ICR 200612-0910-002 · 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⚠️ Notice: This information collection may be referencing outdated material.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 User Fee Cover Sheet; Form FDA 3397	Form
3397 Prescription Drug User Fee Coversheet 0297-PDUFAform-blank cover sheet.pdf www.fda.gov/oc/pdufa/coversheet.html	Form
0297-PDUFA CoverSheetInstructions.txt 0297-PDUFA CoverSheetInstructions	IC Document

IC Title:

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	3397	Prescription Drug User Fee Coversheet	0297-PDUFAform-blank cover sheet.pdf	http://www.fda.gov/oc/pdufa/coversheet.html	Yes	Yes	Printable Only

Line of Business: Health

Subfunction:

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 243

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	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	3,762	531	3,231
Annual IC Time Burden (Hours)	1,129	160	969
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
0297-PDUFA CoverSheetInstructions	0297-PDUFA CoverSheetInstructions.txt	12/08/2006

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.