Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0456	ICR Reference No: 201211-0910-003
Status: Historical Active	Previous ICR Reference No: 200912-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: PHS Guideline on Infectious Disease Issues in Xenotransplantation
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 with change	Conclusion Date: 03/20/2013
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/09/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2016	36 Months From Approved	03/31/2013
Responses	139	0	50
Time Burden (Hours)	47	0	156
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	139	50	89
Annual Time Burden (Hours)	47	156	-109
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: The number of responses is up because the information collections are counted separately in this submission. While the information collections have not changed; parsing them out separately gives the appearance of increases responses. The average time burden is down because there are fewer respondents.