Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies - 21 CFR Part 58

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0119 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

View Information Collection (IC)

IC Title:	Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies - 21 CFR Part 58	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 355 21 CFR 360(b) 21 CFR 348 21 CFR 360(e) (To search for a specific CFR, visit the Code of Federal Regulations.)

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: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 300	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	36,150	0	36,150
Annual IC Time Burden (Hours)	1,304,157	-7,000	1,311,157
Annual IC Cost Burden (Dollars)	0	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.