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Medical Devices: Medical Device Reporting, User Facility Reporting, Manufacturer Reporting, Certification, Registration (Final Rule)
Medical Devices: Medical Device Reporting, User Facility Reporting, Manufacturer Reporting, Certification, Registration (Final Rule)
OMB: 0910-0059
IC ID: 5710
OMB.report
HHS/FDA
OMB 0910-0059
ICR 199512-0910-001
IC 5710
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0059 can be found here:
2000-04-10 - No material or nonsubstantive change to a currently approved collection
1999-09-30 - No material or nonsubstantive change to a currently approved collection
Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Medical Devices: Medical Device Reporting, User Facility Reporting, Manufacturer Reporting, Certification, Registration (Final Rule)
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Migrated
Obligation to Respond:
Voluntary
CFR Citation:
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Form
3419
No
No
Form
2892
No
No
Form
2891
No
No
Form
3417
No
No
Form
2891A
No
No
Form
3381
No
No
Federal Enterprise Architecture Business Reference Module
Line of Business:
Subfunction:
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
72,905
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
127,900
0
81,100
0
0
46,800
Annual IC Time Burden (Hours)
188,110
0
-12,819
0
0
200,929
Annual IC Cost Burden (Dollars)
68,280,000
0
68,280,000
0
0
0
Documents for IC
Title
Document
Date Uploaded
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.