View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0130	ICR Reference No: 201012-0910-005
Status: Historical Active	Previous ICR Reference No: 200711-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Protection of Human Subjects; Recordkeeping Requirements for Institutional Review Boards (IRBs)
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: 04/25/2011
	Date Received in OIRA: 12/27/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2014	36 Months From Approved	04/30/2011
Responses	36,500	0	73,000
Time Burden (Hours)	3,650,000	0	7,300,000
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	36,500	73,000	-36,500
Annual Time Burden (Hours)	3,650,000	7,300,000	-3,650,000
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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