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View ICR - OIRA Conclusion

OMB Control No: 0910-0052	ICR Reference No: 201501-0910-007
Status: Historical Active	Previous ICR Reference No: 201201-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Blood Establishment Registration and Product Listing, 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 with change	Conclusion Date: 05/18/2015
	Date Received in OIRA: 02/09/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved	05/31/2015
Responses	2,849	0	2,818
Time Burden (Hours)	1,418	0	1,389
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	2,849	2,818	31
Annual Time Burden (Hours)	1,418	1,389	29
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 estimated total annual burden for this information collection was 1,389 hours in 2011. The slight increase to 1,418 hours (+29 hours) is mostly attirbuted to an increase in the number of initial registrations of blood product establishments (foreign and domestic).

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