Federal Register / Vol. 79, No. 239 / Friday, December 12, 2014 / Notices 73891 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers CMS–10341, CMS–R– 

246 and CMS–10531] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish a notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

any of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments must be received by 

February 10, 2015. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number (OCN). To be 

assured consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number lll, Room C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/Paperwork

ReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10341 Affordable Care Act 

Information and Collection 

Requirements for Section 1115 

Demonstration Projects 

CMS–R–246 Medicare Advantage, 

Medicare Part D, and Medicare FeeFor-Service Consumer Assessment 

of Healthcare Providers and 

Systems (CAHPS) Survey 

CMS–10531 Transcatheter Mitral Valve 

Repair (TMVR) National Coverage 

Decision (NCD) 

Under the Paperwork Reduction Act 

(PRA) (44 U.S.C. 3501–3520), federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Affordable Care 

Act Information and Collection 

Requirements for Section 1115 

Demonstration Projects; Use: This 

collection is necessary to ensure that 

states comply with regulatory and 

statutory requirements related to the 

development, implementation and 

evaluation of demonstration projects. 

States seeking waiver authority under 

Section 1115 are required to meet 

certain requirements for public notice, 

the evaluation of demonstration 

projects, and reports to the Secretary on 

the implementation of approved 

demonstrations. Form Number: CMS– 

10341 (OMB control number 0938– 

1162); Frequency: Yearly; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

37; Total Annual Responses: 130; Total 

Annual Hours: 13,910. (For policy 

questions regarding this collection 

contact Lane Terwilliger at 410–786– 

2059). 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicare 

Advantage, Medicare Part D, and 

Medicare Fee-For-Service Consumer 

Assessment of Healthcare Providers and 

Systems (CAHPS) Survey; Use: The 

primary purpose of the Medicare 

consumer assessment of healthcare 

providers and systems (CAHPS) surveys 

is to provide information to Medicare 

beneficiaries to help them make more 

informed choices among health and 

prescription drug plans available to 

them. The surveys also provides data to 

help CMS and others monitor the 

quality and performance of Medicare 

health and prescription drug plans and 

identify areas to improve the quality of 

care and services provided to enrollees 

of these plans. Form Number: CMS–R– 

246 (OMB control number: 0938–0732; 

Frequency: Yearly; Affected Public: 

Individuals and households; Number of 

Respondents: 799,650; Total Annual 

Responses: 799,650; Total Annual 

Hours: 277,740 (For policy questions 

regarding this collection contact Sarah 

Gaillot at 410–786–4637). 

3. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Transcatheter 

Mitral Valve Repair (TMVR) National 

Coverage Decision (NCD); Use: The data 

collection is required by the Centers for 

Medicare and Medicaid Services (CMS) 

National Coverage Determination (NCD) 

entitled, ‘‘Transcatheter Mitral Valve 

Repair (TMVR)’’. The TMVR device is 

only covered when specific conditions 

are met including that the heart team 

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73892 Federal Register / Vol. 79, No. 239 / Friday, December 12, 2014 / Notices 

and hospital are submitting data in a 

prospective, national, audited registry. 

The data includes patient, practitioner 

and facility level variables that predict 

outcomes such as all-cause mortality 

and quality of life. 

We find 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 TMVR. The 

TVT Registry will support a national 

surveillance system to monitor the 

safety and efficacy of the TMVR 

technologies for the treatment of mitral 

regurgitation (MR). The data will also 

include the variables on the eight item 

Kansas City Cardiomyopathy 

Questionnaire (KCCQ–10) to assess 

heath status, functioning and quality of 

life. In the KCCQ, an overall summary 

score can be derived from the physical 

function, symptoms (frequency and 

severity), social function and quality of 

life domains. For each domain, the 

validity, reproducibility, responsiveness 

and interpretability have been 

independently established. Scores are 

transformed to a range of 0–100, in 

which higher scores reflect better health 

status. 

The conduct of the STS/ACC TVT 

Registry and the KCCQ–10 is pursuant 

to Section 1142 of the Social Security 

Act (the ACT) that describes the 

authority of the Agency for Healthcare 

Research and Quality (AHRQ). Under 

section 1142, research may be 

conducted and supported on the 

outcomes, effectiveness, and 

appropriateness of health care services 

and procedures to identify the manner 

in which disease, disorders, and other 

health conditions can be prevented, 

diagnosed, treated, and managed 

clinically. Section 1862(a)(1)(E) of the 

Act allows Medicare to cover under 

coverage with evidence development 

(CED) certain items or services for 

which the evidence is not adequate to 

support coverage under section 

1862(a)(1)(A) and where additional data 

gathered in the context of a clinical 

setting would further clarify the impact 

of these items and services on the health 

of beneficiaries. 

The data collected and analyzed in 

the TVT Registry will be used to 

determine if TMVR is reasonable and 

necessary (e.g., improves health 

outcomes) for Medicare beneficiaries 

under Section 1862(a)(1)(A) of the ACT. 

Furthermore, data from the Registry will 

assist the medical device industry and 

the Food and Drug Administration 

(FDA) in surveillance of the quality, 

safety and efficacy of new medical 

devices to treat mitral regurgitation. For 

purposes of the TMVR NCD, the TVT 

Registry has contracted with the Data 

Analytic Centers to conduct the 

analyses. In addition, data will be made 

available for research purposes under 

the terms of a data use agreement that 

only provides de-identified datasets. 

Form Number: CMS–10531(OMB 

Control Number: 0938–NEW); 

Frequency: Annually; Affected Public: 

Business or other for-profits; Number of 

Respondents: 4,000; Total Annual 

Responses: 16,000 Total Annual Hours: 

5,600. (For policy questions regarding 

this collection contact Roya Lotfi at 

410–786–4072.) 

Dated: December 9, 2014. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2014–29172 Filed 12–11–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Adoption and Foster Care 

Analysis Reporting System for title IV– 

B and title IV–E, AFCARS. 

OMB No.: 0970–0422. 

Description: The Adoption and Foster 

Care Analysis and Reporting System 

(AFCARS) is mandated by 42 U.S.C. 

679. The regulation at 45 CFR part 1355 

sets forth the requirements of the statute 

for the collection of uniform, reliable 

information on children who are under 

the responsibility of the State or Tribal 

title IV–B/IV–E agency for placement, 

care, and adoption. Effective October 1, 

2009, section 479B(b) of the Act 

authorizes direct Federal funding of 

Indian Tribes, Tribal organizations, and 

Tribal consortia that choose to operate 

a foster care, adoption assistance and, at 

Tribal option, a kinship guardianship 

assistance program under title IV–E of 

the Act. The Federal regulations at 45 

CFR 1355.40 were amended as part of 

an Interim Final Rule published January 

6, 2012 to apply the same regulatory 

requirements for data collection and 

reporting to a Tribal title IV–E agency as 

are applied to a State title IV–E agency. 

The data collected will inform State/ 

Tribal/Federal policy decisions, 

program management, and responses to 

Congressional and Departmental 

inquiries. Specifically, the data are used 

for short/long-term budget projections, 

trend analysis, child and family service 

reviews, and to target areas for 

improved technical assistance. The data 

will provide information about foster 

care placements, adoptive parents, 

length of time in care, delays in 

termination of parental rights and 

placement for adoption. 

Respondents: Title IV–E State and 

Tribal Child Welfare Agencies 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

AFCARS .......................................................................................................... 72 2 1786 257,184 

Estimated Total Annual Burden 

Hours: 257,184. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 370 

L’Enfant Promenade SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. Email address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

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