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View ICR - OIRA Conclusion

OMB Control No: 0910-0302	ICR Reference No: 201312-0910-010
Status: Historical Active	Previous ICR Reference No: 201011-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: 21075
Title: Human Tissue Intended for Transplantation
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: 01/27/2014
	Date Received in OIRA: 12/20/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2017	36 Months From Approved	01/31/2014
Responses	806,011	0	1,079,817
Time Burden (Hours)	806,770	0	1,080,760
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	806,011	1,079,817	-273,806
Annual Time Burden (Hours)	806,770	1,080,760	-273,990
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: No

Burden Reduction Due to:

Short Statement: The previous burden estimate in 2011 was 1,080,760 hours. The decrease in burden to 806,770 (-273,990) hours is mostly attributed to a decrease in the number of establishments and a corresponding decrease in the number of total annual records under all the listed regulations.

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