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Device Facility User Fee Cover Sheet (Form FDA 3601(a))
Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet — Form FDA 3601 and Form 3601(a)
OMB: 0910-0511
IC ID: 248796
OMB.report
HHS/FDA
OMB 0910-0511
ICR 202107-0910-002
IC 248796
( )
⚠️ Notice: This information collection may be referencing outdated material.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
Form FDA 3601(a)
Device Facility User Fee Cover Sheet (Form FDA 3601(a))
Form
FDA 3601(a) Device Facility User Fee
0511_Form 3601(a).pdf
Form
FDA 3601(a) Device Facility User Fee
0511_Form 3601(a).pdf
Form
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Device Facility User Fee Cover Sheet (Form FDA 3601(a))
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
New
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 3601(a)
Device Facility User Fee
0511_Form 3601(a).pdf
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:
24,086
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
0 %
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
24,086
0
0
24,086
0
0
Annual IC Time Burden (Hours)
4,095
0
0
4,095
0
0
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.