View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0513	ICR Reference No: 201007-0910-003
Status: Historical Active	Previous ICR Reference No: 200704-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Applications for FDA Approval to Market a New Drug: Patient Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...
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: 10/18/2010
	Date Received in OIRA: 07/23/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2013	36 Months From Approved	10/31/2010
Responses	1,006	0	673
Time Burden (Hours)	14,120	0	8,840
Cost Burden (Dollars)	0	0	0

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