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View ICR - OIRA Conclusion

OMB Control No: 0910-0582	ICR Reference No: 200610-0910-002
Status: Historical Active	Previous ICR Reference No: 200601-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
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: 01/04/2007
	Date Received in OIRA: 10/05/2006
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2010	36 Months From Approved	01/31/2007
Responses	700	0	600
Time Burden (Hours)	2,800	0	2,400
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	700	600	100
Annual Time Burden (Hours)	2,800	2,400	400
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: FDA made an adjustment increase in the number of respondents from 600 to 700 thereby increasing the burden hours from 2400 to 2800 due to expansion of the scope of the guidance which meant an increase in the number of studies.

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