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View ICR - OIRA Conclusion

OMB Control No: 0910-0302	ICR Reference No: 201011-0910-003
Status: Historical Active	Previous ICR Reference No: 200704-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
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: 01/30/2011
	Date Received in OIRA: 11/24/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2014	36 Months From Approved	01/31/2011
Responses	1,079,817	0	782,562
Time Burden (Hours)	1,080,760	0	783,332
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	1,079,817	782,562	-28	297,283
Annual Time Burden (Hours)	1,080,760	783,332	-672	298,100
Annual Cost Burden (Dollars)	0	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: The previous burden estimate was 783,332 hours. The increase in burden to 1,080,760 (~ 300,000) hours is mostly attributed to an increase in the number of establishments and number of total annual records under 1270.33 (~100,000 hours) and 1270.35 (~200,000 hours). The reduction listed as a program change is the result of an elimination of an IC. Those burden hours were transferred to another IC and do not represent a reduction in burden.

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