View ICR - OIRA Conclusion



0910-0014 200905-0910-005
Historical Active 200602-0910-005
HHS/FDA
Investigational New Drug Regulations
Extension without change of a currently approved collection   No
Regular
Approved with change 08/06/2009
Retrieve Notice of Action (NOA) 05/28/2009
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
08/31/2011 36 Months From Approved 08/31/2009
2,744,640 2,744,640 1,277,517
141,492,162 141,492,162 71,369,525
0 0 0