12180 Federal Register / Vol. 80, No. 44 / Friday, March 6, 2015 / Notices 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

In-class evaluations ........................................................... 40,000 1 40,000 .05 2,000 

Mail/Telephone/Online Surveys ......................................... 12,000 1 12,000 .25 3,000 

Focus groups ..................................................................... 250 1 250 1 .5 375 

Total ............................................................................ 52,250 1 52,250 .103 5,375 

Jackie Painter, 

Director, Division of the Executive Secretariat. 

[FR Doc. 2015–05187 Filed 3–5–15; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–1557, CMS– 

10531 and CMS–10535] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

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 

(PRA), federal agencies are required to 

publish 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 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate 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 on the collection(s) of 

information must be received by the 

OMB desk officer April 6, 2015. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806 or Email: 

OIRA_submission@omb.eop.gov. 

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: Under the 

Paperwork Reduction Act of 1995 (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 (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-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 that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Survey Report 

Form for Clinical Laboratory 

Improvement Amendments (CLIA) and 

Supporting Regulations; Use: The form 

is used to report surveyor findings 

during a CLIA survey. For each type of 

survey conducted (i.e., initial 

certification, recertification, validation, 

complaint, addition/deletion of 

specialty/subspecialty, transfusion 

fatality investigation, or revisit 

inspections) the Survey Report Form 

incorporates the requirements specified 

in the CLIA regulations. Form Number: 

CMS–1557 (OMB control number: 

0938–0544); Frequency: Biennially; 

Affected Public: Private sector (Business 

or other for-profit and Not-for-profit 

institutions, State, Local or Tribal 

Governments and Federal Government); 

Number of Respondents: 19,051; Total 

Annual Responses: 9,526; Total Annual 

Hours: 4,763. (For policy questions 

regarding this collection contact 

Kathleen Todd at 410–786–3385). 

2. 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 

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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 44 / Friday, March 6, 2015 / Notices 12181 

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: 

Private sector (Business or other forprofits); 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). 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Employer 

Notification to HHS of its Objection to 

Providing Coverage for Contraceptive 

Services; Use: The proposed rules titled 

‘‘Coverage of Certain Preventive 

Services Under the Affordable Care Act’’ 

(79 FR 51118), if finalized as proposed, 

would require each qualifying closelyheld, for-profit entity seeking to be 

treated as an eligible organization to 

provide notification of its religious 

objection to coverage of all or a subset 

of contraceptive services. Issuers and 

third party administrators providing or 

arranging payments for contraceptive 

services for participants and 

beneficiaries in plans of eligible 

organizations would be required to meet 

the notice requirements as set forth in 

the 2013 final regulations, requiring 

them to provide notice of the 

availability of separate payments for 

contraceptive services to participants 

and beneficiaries in the eligible 

organizations’ plans (78 FR 39870, 

39880 (July 2, 2013)). 

The interim final regulations titled 

‘‘Coverage of Certain Preventive 

Services Under the Affordable Care Act’’ 

(79 FR 51092) continue to allow eligible 

organizations that have religious 

objections to providing contraceptive 

coverage to notify an issuer or third 

party administrator using EBSA Form 

700, as set forth in the 2013 final 

regulations. In addition, these interim 

final regulations permit an alternative 

process under which an eligible 

organization may notify HHS of its 

religious objection to coverage of all or 

a subset of contraceptive services. 

Form Number: CMS–10535 (OMB 

control number: 0938–1248); Frequency: 

Once; Affected Public: Private sector 

(Business or other for-profits and notfor-profit institutions); Number of 

Respondents: 61; Number of Responses: 

61; Total Annual Hours: 51. (For policy 

questions regarding this collection, 

contact Usree Bandyopadhyay at 410– 

786–6650.) 

Dated: March 2, 2015. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2015–05165 Filed 3–5–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10464] 

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 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 

May 5, 2015. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. 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 

mstockstill on DSK4VPTVN1PROD with NOTICES