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View ICR - OIRA Conclusion

OMB Control No: 0910-0302	ICR Reference No: 200704-0910-003
Status: Historical Active	Previous ICR Reference No: 200401-0910-011
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 with change	Conclusion Date: 08/20/2007
	Date Received in OIRA: 04/27/2007
Terms of Clearance: This information collection request is approved as revised. Note that the burden tables were changed to reflect that the burden changes were due to adjustment rather than agency action, consistent with submission as "extension without change."

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2010	36 Months From Approved	08/31/2007
Responses	782,562	0	62
Time Burden (Hours)	783,332	0	592,166
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	782,562	62	782,500
Annual Time Burden (Hours)	783,332	592,166	191,166
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 increase in burden is due to the increase in the number of conventional tissue products. The number doubled since our last request for approval.

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