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View ICR - OIRA Conclusion

OMB Control No: 0938-1202	ICR Reference No: 201606-0938-003
Status: Historical Active	Previous ICR Reference No: 201211-0938-005
Agency/Subagency: HHS/CMS	Agency Tracking No:
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: 12/11/2017
	Date Received in OIRA: 06/21/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2020	36 Months From Approved	12/31/2017
Responses	59,484	0	24,000
Time Burden (Hours)	19,184	0	7,000
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	59,484	24,000	35,484
Annual Time Burden (Hours)	19,184	7,000	12,184
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: The changes to burden are due to calculations based on averages of the actual number of TAVR procedures performed since the original PRA package was created. The original numbers were estimates that were not based on experience as these were new processes at the time.

Annual Cost to Federal Government: $3,130

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? Uncollected

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

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