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Recordkeeping by device-led, drugs and biologics-led combination products; and shared records
Postmarketing Safety Reporting for Combination Products
OMB: 0910-0834
IC ID: 191024
OMB.report
HHS/FDA
OMB 0910-0834
ICR 202008-0910-012
IC 191024
( )
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 by device-led, drugs and biologics-led combination products; and shared records
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Removed
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 4.105
21 CFR 4.103
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:
498
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
10 %
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
0
0
-4,059
0
0
4,059
Annual IC Time Burden (Hours)
0
0
-680
0
0
680
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.