Transcatheter Valve Therapy Registry and KCCQ-10

Forms and Documents

Document Name	Status
Form CMS-10443 KCCQ-10 Form and Instruction	New
Form CMS-10443 TVT Registry Form and Instruction	New
TAVR Data Supporting Statement - Part B (3).doc Supporting Statement B	2012-11-05
CMS-10443 Supporting Statement Part A (4).doc Supporting Statement A	2012-11-05

IC Document Collections

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

ICR Details

OMB Control No: 0938-1202	ICR Reference No: 201211-0938-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Transcatheter Valve Therapy Registry and KCCQ-10
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/10/2013
	Date Received in OIRA: 11/20/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2016	36 Months From Approved
Responses	24,000	0	0
Time Burden (Hours)	7,000	0	0
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:
	77 FR 53202	08/31/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 68785	11/16/2012
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 Data Collection Form
KCCQ-10	CMS-10443	KCCQ-10

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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	24,000	0	24,000	0	0	0
Annual Time Burden (Hours)	7,000	0	7,000	0	0	0
Annual Cost Burden (Dollars)	0	0	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: No

Burden Reduction Due to:

Short Statement: This is a new collection.

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Annual Cost to Federal Government: $1,263

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 11/20/2012

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