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First Year (one time)
Guidance Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program
OMB: 0910-0700
IC ID: 198426
OMB.report
HHS/FDA
OMB 0910-0700
ICR 201412-0910-004
IC 198426
( )
Documents and Forms
Document Name
Document Type
ISO13485 eSubmitter Screenshots.doc
Other-Screenshots
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
First Year (one time)
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
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
Other-Screenshots
ISO13485 eSubmitter Screenshots.doc
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:
567
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
567
0
34
0
0
533
Annual IC Time Burden (Hours)
23,814
0
1,428
0
0
22,386
Annual IC Cost Burden (Dollars)
17,010
0
1,020
0
0
15,990
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.