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Agenda
Reg Review
ICR
View Information Collection (IC)
View Information Collection (IC)
IC Title:
Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Mandatory
CFR Citation:
42 CFR 400.493
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:
40
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
40
0
0
0
0
40
Annual IC Time Burden (Hours)
160,000
0
0
16,800
0
143,200
Annual IC Cost Burden (Dollars)
350,000
0
0
350,000
0
0
Documents for IC
Title
Document
Date Uploaded
CLIA Guidance
CLIA Guidance.pdf
04/19/2013
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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The .gov means it's official.
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