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View ICR - OIRA Conclusion

OMB Control No: 0910-0052	ICR Reference No: 201201-0910-002
Status: Historical Active	Previous ICR Reference No: 200812-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Blood Establishment Registration and Product Lising Form FDA 2830
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: 03/08/2012
	Date Received in OIRA: 01/04/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2015	36 Months From Approved	03/31/2012
Responses	2,818	0	2,621
Time Burden (Hours)	1,389	0	1,467
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	2,818	2,621	197
Annual Time Burden (Hours)	1,389	1,467	-78
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 current decrease to 1,389 hours (-78 hours) is mostly attributed to a decrease in the number of initial registrations of blood product establishments (foreign and domestic). The increase in the number of responses is a result of a technical change in how this collection is organized in the system -- i.e., FDA separated one IC into three for clarity.

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