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User Fee Cover Sheet; Form FDA 3397
User Fee Cover Sheet
OMB: 0910-0297
IC ID: 5861
OMB.report
HHS/FDA
OMB 0910-0297
ICR 200612-0910-002
IC 5861
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0297 can be found here:
2022-02-23 - Revision of a currently approved collection
2020-08-03 - No material or nonsubstantive change to a currently approved collection
Documents and Forms
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
Information Collection (IC) Details
View Information Collection (IC)
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
3397
Prescription Drug User Fee Coversheet
0297-PDUFAform-blank cover sheet.pdf
http://www.fda.gov/oc/pdufa/coversheet.html
Yes
Yes
Printable Only
Federal Enterprise Architecture Business Reference Module
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 %
Approved
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
3,762
0
531
0
0
3,231
Annual IC Time Burden (Hours)
1,129
0
160
0
0
969
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
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.