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Annual review and product listing update of registration
Blood Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
OMB: 0910-0052
IC ID: 200688
OMB.report
HHS/FDA
OMB 0910-0052
ICR 201804-0910-015
IC 200688
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0052 can be found here:
2024-06-28 - Extension without change of a currently approved collection
2021-06-11 - Revision of a currently approved collection
Documents and Forms
Document Name
Document Type
0052 Screen Shots - eBER.pdf
Other-eSystem screen shots
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Annual review and product listing update of registration
Agency IC Tracking Number:
CBER
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 607
21 CFR 607.21, 607.22, 607.25, 607.26
21 CFR 607.30, 607.31, 607.35
21 CFR 607.37, 607.39
21 CFR 607.40
21 CFR 607.65
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-eSystem screen shots
0052 Screen Shots - eBER.pdf
Yes
Yes
Fillable Fileable
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:
2,812
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
2,812
0
0
197
0
2,615
Annual IC Time Burden (Hours)
1,356
0
0
48
0
1,308
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.