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View ICR - OIRA Conclusion

OMB Control No: 0910-0582	ICR Reference No: 201604-0910-001
Status: Historical Active	Previous ICR Reference No: 201302-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable
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: 08/01/2016
	Date Received in OIRA: 04/15/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2019	36 Months From Approved	07/31/2016
Responses	700	0	700
Time Burden (Hours)	2,800	0	2,800
Cost Burden (Dollars)	0	0	0

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