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: 0910-0014	ICR Reference No: 200905-0910-005
Status: Historical Active	Previous ICR Reference No: 200602-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Investigational New Drug Regulations
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: 08/06/2009
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/28/2009
Terms of Clearance: This ICR is approved consistent with revised supporting statement. This ICR does not reflect any burden changes as a result of the expanded access or charging final rules. We understand that FDA plans to cover those incremental burden changes in a separate ICR. Prior to next submission, FDA agrees to reconcile the cost and burden estimates in that separate ICR with the cost and burden estimates in this ICR, and then discontinue that separate ICR.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2011	36 Months From Approved	08/31/2009
Responses	2,744,640	0	1,277,517
Time Burden (Hours)	141,492,162	0	71,369,525
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	2,744,640	1,277,517	1,467,123
Annual Time Burden (Hours)	141,492,162	71,369,525	70,122,637
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: