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: 0915-0157	ICR Reference No: 201411-0915-004
Status: Historical Active	Previous ICR Reference No: 201202-0915-001
Agency/Subagency: HHS/HSA	Agency Tracking No:
Title: Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients Data System
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/18/2015
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/16/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2018	36 Months From Approved	03/31/2015
Responses	472,418	0	477,327
Time Burden (Hours)	373,729	0	258,318
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	472,418	477,327	-4,909
Annual Time Burden (Hours)	373,729	258,318	115,411
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Currently, there are a total of 358,092.5 burden hours in the OMB inventory. The total burden hours has increased since 2011 by 79,326 hours. This increase represents a change in burden estimates based on analysis of the most recent trends in OPTN data form submissions. The current estimates should be a more accurate reflection of total burden since the forms were broken out in a more granular fashion. The pilot study participants provided feedback on each type of form as opposed to grouping them only by organ. For example, a 6 month heart follow up form is much shorter than a 1-5 year heart follow up form and should not require as much effort to complete. There are several factors that must be considered when analyzing the additional burden hours. OPTN policy mandates that transplant programs follow transplant recipients until graft failure, re-transplant or death. So as patient and graft survival increases the number of recipients still alive with a functioning graft increases, and the transplant centers will be responsible for completing more forms. Although it is a slight increase in the burden hours, the burden assessment took into account the three additional VCA forms. The frame work of the VCA forms is based on the current Liver Candidate Registration, Liver Recipient Registration and the Liver Recipient Follow Up. The burden hours for those forms were used for VCA as well since the forms are not currently active. Looking forward, the burden time should trend slightly downward after the modifications from this submission.