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Reprocessed Single-Use Device Labeling
Prominent and Conspicuous Mark of Manufacturers on Single - Use Devices ( formerly "Reprocessed Single-Use Device Labeling."
OMB: 0910-0577
IC ID: 6300
OMB.report
HHS/FDA
OMB 0910-0577
ICR 200902-0910-002
IC 6300
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0577 can be found here:
2018-04-13 - Extension without change of a currently approved collection
2015-04-23 - Revision of a currently approved collection
Documents and Forms
Document Name
Document Type
Guidance - 0910-0577.pdf
Other-Guidance with specific labelin
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Reprocessed Single-Use Device Labeling
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
Other-Guidance with specific labeling instructions
Guidance - 0910-0577.pdf
Yes
No
Printable Only
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:
10
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
1,000
0
0
700
0
300
Annual IC Time Burden (Hours)
100
0
0
70
0
30
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.