User Fee Cover Sheet; Form FDA 3397

User Fee Cover Sheet

⚠️ Notice: This information collection may be referencing outdated material.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 FDA 3397 User Fee Cover Sheet; Form FDA 3397 Form
FDA 3397 User Fee Cover Sheet UserFeecoversheetform3397Jones092209 (3).doc Form
UserFeeCoverSheetBackInstructions 11 2009.doc User Fee Instructions IC Document

Information Collection (IC) Details

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:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	FDA 3397	User Fee Cover Sheet	UserFeecoversheetform3397Jones092209 (3).doc		Yes	No	Printable Only

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 255	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 15 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	3,917	155	3,762
Annual IC Time Burden (Hours)	1,959	830	1,129
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
User Fee Instructions	UserFeeCoverSheetBackInstructions 11 2009.doc	11/10/2009

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