View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0701	ICR Reference No: 201412-0910-017
Status: Historical Active	Previous ICR Reference No: 201107-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
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: 04/06/2015
	Date Received in OIRA: 01/08/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2018	36 Months From Approved	04/30/2015
Responses	6,500	0	6,500
Time Burden (Hours)	262,000	0	262,000
Cost Burden (Dollars)	0	0	0

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