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Medical Devices, Third Party Premarket Submission Review and Quality System Inspections Under U.S./E.C. MRA
Medical Devices, Third Party Premarket Submission Review and Quality System Inspections Under U.S./E.C. MRA
OMB: 0910-0378
IC ID: 6022
OMB.report
HHS/FDA
OMB 0910-0378
ICR 200501-0910-001
IC 6022
( )
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:
Medical Devices, Third Party Premarket Submission Review and Quality System Inspections Under U.S./E.C. MRA
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Migrated
Obligation to Respond:
Voluntary
CFR Citation:
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:
Subfunction:
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
15
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
210
0
0
-10
0
220
Annual IC Time Burden (Hours)
14,622
0
0
8,862
0
5,760
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.