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View ICR - OIRA Conclusion

OMB Control No: 0938-1202	ICR Reference No: 202011-0938-010
Status: Historical Active	Previous ICR Reference No: 201606-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: (CMS-10443) Transcatheter Valve Therapy Registry and KCCQ-10
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: 08/06/2021
	Date Received in OIRA: 11/30/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2024	36 Months From Approved	08/31/2021
Responses	148,884	0	59,484
Time Burden (Hours)	47,765	0	19,184
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	148,884	59,484	89,400
Annual Time Burden (Hours)	47,765	19,184	28,581
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 changes to burden are due to calculations based on averages of the number of TAVR procedures performed in 2016, 2017, 2018 and 2019 as well as the increases in mean wages since 2016. The increase in the annual number of TAVR procedures performed is representative of the evolving field, new and expanded FDA approvals and providers growing more comfortable with performing and providing the service. The respondents increased from 14,871 to 37,221. The burden hours increased from 19,184 to 47,765.

Annual Cost to Federal Government: $3,488

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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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