Information Collection

User Fee Cover Sheet; Form FDA 3397

IC 5861 under ICR 200911-0910-003 · 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⚠️ Notice: This information collection may be referencing outdated material.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 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

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	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 %

table that charts list of burden
	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

table that charts IC Documents
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.