Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0308	ICR Reference No: 200807-0910-007
Status: Historical Active	Previous ICR Reference No: 200505-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Adverse Experience Reporting for Licensed Biological Product; and General Records
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: 09/23/2008
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/21/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2011	36 Months From Approved	09/30/2008
Responses	98,732	0	22,324
Time Burden (Hours)	895,663	0	493,522
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	98,732	22,324	54,536	21,872
Annual Time Burden (Hours)	895,663	493,522	0	402,141
Annual Cost Burden (Dollars)	0	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 493,522 hours in 2005. The current increase to 895,639 burden hours is mostly attributed to the increase in the number of reports (total annual responses) submitted under 21 CFR 600.80.