View Information Collection Request (ICR) Package

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: 0938-0688	ICR Reference No: 202012-0938-008
Status: Historical Active	Previous ICR Reference No: 201704-0938-008
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: (CMS-R-13) Conditions of Coverage for Organ Procurement Organizations (OPOs) and Supporting Regulations
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: 05/26/2021
	Date Received in OIRA: 12/10/2020
Terms of Clearance: Approved consistent with the understanding that future changes associated with the next certification cycle will be discussed with CMS' desk officer.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2024	36 Months From Approved	05/31/2021
Responses	114	0	128
Time Burden (Hours)	741	0	13,234
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	114	128	-12	-2
Annual Time Burden (Hours)	741	13,234	-12,480	-13
Annual Cost Burden (Dollars)	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: In regards to the revision request associated with this ICR, we are removing burden associated with death record reviews at 486.348(b). While this requirement is still in place, it is now a usual and customary practice for OPOs that has been in effect since 2006. The previous burden estimate carried over from 2010 when OPOs were still adapting to this requirement and may have needed to increase staffing for this purpose. However, death record review is now considered usual and customary practice for OPOs. This reduces the burden by 12,480 hours and $923,520. The overall change in burden from the previously approved package is a decrease 12,493 hours from 13,234 hours to 741.

Annual Cost to Federal Government: $2,748

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: Denise King 410 786-1013 Denise.King@cms.hhs.gov

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