Information Collection

Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies

IC 5731 under ICR 202312-0910-006 · OMB 0910-0119.

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IC Title:

Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 58

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: 300

Number of Respondents for Small Entity: 150

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 95 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	36,150	36,150
Annual IC Time Burden (Hours)	1,304,157	1,304,157
Annual IC Cost Burden (Dollars)	0	0

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