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Recordkeeping for Electronic Products
Electronic Products Requirements
OMB: 0910-0025
IC ID: 193017
OMB.report
HHS/FDA
OMB 0910-0025
ICR 202406-0910-007
IC 193017
( )
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:
Recordkeeping for Electronic Products
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Unchanged
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR Subpart J Radiological Health 21 CFR parts 1000-1050.10 (To search for a specific CFR, visit the
Code of Federal Regulations.
)
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
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:
4,438
Number of Respondents for Small Entity:
400
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
50 %
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
2,470,420
0
0
0
0
2,470,420
Annual IC Time Burden (Hours)
286,350
0
0
0
0
286,350
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.