Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications

CLIA Waiver Applications

Documents and Forms

Document Name Document Type
0598_CLIA Waiver Guidance.docx CLIA Waiver Guidance IC Document

Information Collection (IC) Details

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 13	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	13	-27	40
Annual IC Time Burden (Hours)	52,000	-108,000	160,000
Annual IC Cost Burden (Dollars)	113,750	-236,250	350,000

Documents for IC

Title	Document	Date Uploaded
CLIA Waiver Guidance	0598_CLIA Waiver Guidance.docx	06/23/2016

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