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Reporting; Manufacturer Reporting-- 803.50 through 803.53
Medical Device Reporting
OMB: 0910-0437
IC ID: 6116
OMB.report
HHS/FDA
OMB 0910-0437
ICR 202412-0910-004
IC 6116
( )
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:
Reporting; Manufacturer Reporting-- 803.50 through 803.53
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 4
21 CFR 803
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-MDR Webpage
Yes
No
Fillable Printable
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:
1,871
Number of Respondents for Small Entity:
150
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
99 %
Requested
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
2,320,393
0
0
863,509
1,456,884
0
Annual IC Time Burden (Hours)
232,039
0
0
86,351
145,688
0
Annual IC Cost Burden (Dollars)
18,710
0
0
18,710
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.