This script is used to control the display of information in this page.
Menu Item - Home
Menu Item - Agenda Main page
Menu Item - Historical Agenda
Menu Item - Historical Agenda
Menu Item - Agenda Search
Menu Item - Agenda XML Reports
Menu Item - EO Dashboard
Menu Item - Reg Review
Menu Item - EO Agency lists
Menu Item - EO Search
Menu Item - EO Historical Reports
Menu Item - Review Counts
Menu Item - OIRA Letters
Menu Item - EOM 12866 Search
Menu Item - EO XML Reports
Menu Item - ICR Dashboard page
Menu Item - ICR Main page
Menu Item - ICR Search
Menu Item - ICR XML Reports
Menu Item - FAQ
Menu Item - Additional Resources
Menu Item - Contact Us
Search: Agenda Reg Review ICR

View ICR - OIRA Conclusion

0910-0014 200905-0910-005
Historical Active 200602-0910-005
Investigational New Drug Regulations
Extension without change of a currently approved collection   No
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

About Us   Vertical Spacer Spacer Related Resources   Vertical Spacer Spacer Disclosure   Vertical Spacer Spacer Accessibility   Vertical Spacer Spacer Privacy Policy   Vertical Spacer Spacer Contact Us