OMB
.report
Search
Medical Device User Fee Cover Sheet - FDA Form 3601
Medical Device User Fee Cover Sheet - FDA Form 3601
OMB: 0910-0511
IC ID: 6227
OMB.report
HHS/FDA
OMB 0910-0511
ICR 201302-0910-003
IC 6227
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0511 can be found here:
2024-09-30 - Revision of a currently approved collection
2023-03-13 - No material or nonsubstantive change to a currently approved collection
Documents and Forms
Document Name
Document Type
Medical Device MDUFMA User Fees Cover sheet instructions.pdf
www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFeeandModernizationAct/ucm155274.htm
Instruction
3601 Medical Device User Fee Cover Sheet
MDUFA cover sheet.pdf
www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFeeandModernizationAct/ucm155274.htm
Form
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Medical Device User Fee Cover Sheet - FDA Form 3601
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
Instruction
Medical Device MDUFMA User Fees Cover sheet instructions.pdf
http://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFeeandModernizationAct/ucm155274.htm
Yes
Yes
Printable Only
Form
3601
Medical Device User Fee Cover Sheet
MDUFA cover sheet.pdf
http://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFeeandModernizationAct/ucm155274.htm
Yes
Yes
Fillable Fileable Signable
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Consumer Health and Safety
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
5,192
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
100 %
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
5,214
0
0
22
0
5,192
Annual IC Time Burden (Hours)
1,564
0
0
6
0
1,558
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
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.