(CMS-10443) Transcatheter Valve Therapy Registry and KCCQ-10

Forms and Documents

Document Name	Status
Form CMS-10443 KCCQ-10 Form and Instruction	Modified
Form CMS-10443 TVT Registry Form and Instruction	Modified
CMS-10443 Supporting Statement - Part B - 120617.doc Supporting Statement B	2017-12-08
CMS-10443 Supporting Statement Part A - 120617.doc Supporting Statement A	2017-12-08

IC Document Collections

IC ID	Document Title	Status
204894	KCCQ-10 Form and Instruction	Modified
204893	TVT Registry Form and Instruction	Modified

ICR Details

OMB Control No: 0938-1202	ICR Reference No: 201606-0938-003
Status: 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

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Abstract: The data collection is required by the Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) entitled, “Transcatheter Aortic Valve Replacement (TAVR)”. The TAVR device is only covered when specific conditions are met including that the heart team and hospital are submitting data in a prospective, national, audited registry. CMS finds that the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry, one registry overseen by the National Cardiovascular Data Registry, meets the requirements specified in the NCD on TAVR. The TVT Registry will support a national surveillance system to monitor the safety and efficacy of the TAVR technologies for the treatment of aortic stenosis.

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Authorizing Statute(s): US Code: 42 USC 1320b-12 Name of Law: Social Security Act
   US Code: 42 USC 1395y Name of Law: Social Security Act
  

Citations for New Statutory Requirements: US Code: 42 USC 1320b-12 Name of Law: Social Security Act
US Code: 42 USC 1395y Name of Law: Social Security Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 14854	03/18/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 39644	06/17/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
TVT Registry	CMS-10443	TVT Registry
KCCQ-10	CMS-10443	KCCQ Form

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	59,484	24,000	0	35,484	0	0
Annual Time Burden (Hours)	19,184	7,000	0	12,184	0	0
Annual Cost Burden (Dollars)	0	0	0	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.

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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

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 06/21/2016

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