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View ICR - OIRA Conclusion

OMB Control No: 0910-0458	ICR Reference No: 201006-0910-003
Status: Historical Active	Previous ICR Reference No: 200810-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms 3486 and 3486A
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/30/2011
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/28/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2014	36 Months From Approved	01/31/2011
Responses	46,950	0	44,803
Time Burden (Hours)	90,030	0	85,873
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	46,950	44,803	2,147
Annual Time Burden (Hours)	90,030	85,873	4,157
Annual Cost Burden (Dollars)	0	0	0

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The previous burden estimate in 2006 was 85,873 hours. The current overall increase in burden to 90,030 hours is mostly attributed to the increase (3,712 hours) in the number of annual responses under Sec. 606.171 as well as the addition of Sec. 1271.350(b); (formerly under OMB control number 0910-0543) for consolidation purposes of all deviation reporting.