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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 239 / Friday, December 12, 2014 / Notices 73893 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7285, 

Email: OIRA_SUBMISSION@

OMB.EOP.GOV, Attn: Desk Officer for 

the Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2014–29206 Filed 12–11–14; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects: 

Title: Generic Clearance for Grant 

Reviewer Application Form. 

OMB No.: New. 

Description: This notice announces 

that the Administration for Children 

and Families intends to submit the 

proposed Information Collection 

Request (Generic ICR): Generic 

Clearance for Grant Reviewer 

Application Form under the Paperwork 

Reduction (PRA) (44 U.S.C. 3501 et. 

seq.). Comments on specific aspects for 

the proposed information collection are 

being solicited. 

This request is for approval of a plan 

for conducting more than one 

information collection that is very 

similar, voluntary, low-burden and 

uncontroversial. Information collections 

under this generic clearance will be in 

compliance with U.S. Department of 

Health and Humans Services’ Grants 

Policy Directive 2.04 ‘‘Awarding 

Grants’’, and the Awarding Agency 

Grants Administration Manual, Chapter 

2.04C ‘‘Objective Review of Grant 

Applications’’. These forms will be used 

to select reviewers who will participate 

in the grant review process for the 

purpose of selecting successful 

applications. 

Respondents: Individuals. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

urden hours 

er response 

Total burden 

hours 

Grant Review Application Form ....................................................................... 750 1 0.5 375 

Estimated Total Annual Burden 

Hours: 375. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded 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. 

Email address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2014–29173 Filed 12–11–14; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Cancer 

Institute Special Emphasis Panel, 

January 27, 2015 08:00 a.m. to January 

28, 2015, 06:00 p.m., Bethesda North 

Marriott & Conference Center, Bethesda, 

MD 20852 which was published in the 

Federal Register on November 5, 2014, 

79FR65678. 

The meeting notice is amended to 

change the title of the meeting from 

‘‘NCI Program Project Meeting II’’ to 

‘‘NCI Program Project Meeting I’’. The 

meeting is closed to the public. 

Dated: December 9, 2014. 

Melanie J. Gray, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–29159 Filed 12–11–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: AIDS and AIDS Related Research. 

Date: December 17, 2014. 

Time: 11:00 a.m. to 12:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Robert Freund, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5216, 

mstockstill on DSK4VPTVN1PROD with NOTICES