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Request for CLIA categorization
Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization ( 42 CFR 493.17)
OMB: 0910-0607
IC ID: 180758
OMB.report
HHS/FDA
OMB 0910-0607
ICR 201309-0910-010
IC 180758
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0607 can be found here:
2022-10-26 - Revision of a currently approved collection
2019-10-29 - Extension without change of a currently approved collection
Documents and Forms
Document Name
Document Type
CLIA Guidance 0607.pdf
CLIA Admin Guidance
IC Document
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Request for CLIA categorization
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Required to Obtain or Retain Benefits
CFR Citation:
42 CFR 493.17
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:
60
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
900
0
0
0
0
900
Annual IC Time Burden (Hours)
900
0
0
0
0
900
Annual IC Cost Burden (Dollars)
46,800
0
0
0
0
46,800
Documents for IC
Title
Document
Date Uploaded
CLIA Admin Guidance
CLIA Guidance 0607.pdf
07/29/2010
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.