Request for CLIA categorization

Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization ( 42 CFR 493.17)

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0607 can be found here:

Documents and Forms

Document Name Document Type
0607 guidance.pdf Administrative Procedures for CLIA Categorization Guidance IC Document

Information Collection (IC) Details

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

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	Previously Approved
Annual Number of Responses for this IC	900	900
Annual IC Time Burden (Hours)	900	900
Annual IC Cost Burden (Dollars)	46,800	46,800

Documents for IC

Title	Document	Date Uploaded
Administrative Procedures for CLIA Categorization Guidance	0607 guidance.pdf	09/07/2016

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.