CLIA and ICRs contained in 493.1-.2001

Information Collection Requirements (ICR) Contained in the Clinical Laboratory Improvement Amendments (CLIA) Regulations 42 CFR 493.1-.2001 (CMS-R-26)

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0938-0612 can be found here:

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	CLIA and ICRs contained in 493.1-.2001	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 42 CFR 493.1-.2001

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 10,121	Number of Respondents for Small Entity: 0

Affected Public: State, Local, and Tribal Governments

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	45,373	45,373
Annual IC Time Burden (Hours)	681,820	681,820
Annual IC Cost Burden (Dollars)	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.