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View ICR - OIRA Conclusion

OMB Control No: 0910-0119	ICR Reference No: 201409-0910-010
Status: Historical Active	Previous ICR Reference No: 201107-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies - 21 CFR Part 58
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/23/2014
	Date Received in OIRA: 09/29/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2017	36 Months From Approved	12/31/2014
Responses	36,150	0	36,150
Time Burden (Hours)	1,304,157	0	1,311,157
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	36,150	36,150	0
Annual Time Burden (Hours)	1,304,157	1,311,157	-7,000
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Burden reduction reflects correction of mathematical error recorded previously. This is explained in the Supporting Statement at Q.15.

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