Information Collection

Draft Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications

IC 46257 under ICR 200611-0910-010 · OMB 0910-0598.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0598 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
CLIA GUIDANCE.DOC CLIA GUIDANCE	IC Document

IC Title:

Draft Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications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

Obligation to Respond: Mandatory

CFR Citation: 42 CFR 400.493

Information Collection Instruments:

table that charts list of 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: 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 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	40	40
Annual IC Time Burden (Hours)	143,200	143,200
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
CLIA GUIDANCE	CLIA GUIDANCE.DOC	11/18/2006

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