Federal Register / Vol. 77, No. 76 / Thursday, April 19, 2012 / Notices 23483 

the power to vote shares of a bank or 

bank holding company and all of the 

banks and nonbanking companies 

owned by the bank holding company, 

including the companies listed below. 

The applications listed below, as well 

as other related filings required by the 

Board, are available for immediate 

inspection at the Federal Reserve Bank 

indicated. The applications will also be 

available for inspection at the offices of 

the Board of Governors. Interested 

persons may express their views in 

writing on the standards enumerated in 

the BHC Act (12 U.S.C. 1842(c)). If the 

proposal also involves the acquisition of 

a nonbanking company, the review also 

includes whether the acquisition of the 

nonbanking company complies with the 

standards in section 4 of the BHC Act 

(12 U.S.C. 1843). Unless otherwise 

noted, nonbanking activities will be 

conducted throughout the United States. 

Unless otherwise noted, comments 

regarding each of these applications 

must be received at the Reserve Bank 

indicated or the offices of the Board of 

Governors not later than May 14, 2012. 

A. Federal Reserve Bank of Atlanta 

(Chapelle Davis, Assistant Vice 

President), 1000 Peachtree Street NE., 

Atlanta, Georgia 30309: 

1. IBERIABANK Corporation, 

Lafayette, Louisiana; to merge with 

Florida Gulf Bancorp and thereby 

indirectly acquire Florida Gulf Bank, 

both in Fort Myers, Florida. 

Board of Governors of the Federal Reserve 

System, April 16, 2012. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. 2012–9452 Filed 4–18–12; 8:45 am] 

BILLING CODE 6210–01–P 

FEDERAL RESERVE SYSTEM 

Notice of Proposals To Engage In or 

To Acquire Companies Engaged in 

Permissible Nonbanking Activities 

The companies listed in this notice 

have given notice under section 4 of the 

Bank Holding Company Act (12 U.S.C. 

1843) (BHC Act) and Regulation Y, (12 

CFR part 225) to engage de novo, or to 

acquire or control voting securities or 

assets of a company, including the 

companies listed below, that engages 

either directly or through a subsidiary or 

other company, in a nonbanking activity 

that is listed in § 225.28 of Regulation Y 

(12 CFR 225.28) or that the Board has 

determined by Order to be closely 

related to banking and permissible for 

bank holding companies. Unless 

otherwise noted, these activities will be 

conducted throughout the United States. 

Each notice is available for inspection 

at the Federal Reserve Bank indicated. 

The notice also will be available for 

inspection at the offices of the Board of 

Governors. Interested persons may 

express their views in writing on the 

question whether the proposal complies 

with the standards of section 4 of the 

BHC Act. 

Unless otherwise noted, comments 

regarding the applications must be 

received at the Reserve Bank indicated 

or the offices of the Board of Governors 

not later than May 4, 2012. 

A. Federal Reserve Bank of San 

Francisco (Kenneth Binning, Vice 

President, Applications and 

Enforcement) 101 Market Street, San 

Francisco, California 94105–1579: 

1. Security California Bancorp, 

Riverside, California; to engage de novo 

through its subsidiary, SCB Asset 

Management, Riverside, California, in 

extending credit and servicing loans, 

pursuant to section 225.28(b)(1). 

Board of Governors of the Federal Reserve 

System, April 16, 2012. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. 2012–9453 Filed 4–18–12; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: D HS/ACF/OPRE Head Start 

Classroom-based Approaches and 

Resource for Emotion and Social skill 

promotion (CARES) project: Impact and 

Implementation Studies. 

OMB No. 0970–0364. 

Description: The Head Start 

Classroom-based Approaches and 

Resource for Emotion and Social skill 

promotion (CARES) project is evaluating 

social emotional program enhancements 

within Head Start settings serving 3- 

and 4-year-old children. This project 

focuses on identifying the central 

features of effective programs to provide 

the information federal policy makers 

and Head Start providers will need if 

they are to increase Head Start’s 

capacity to improve the social and 

emotional skills and school readiness of 

preschool age children. The project is 

sponsored by the Office of Planning, 

Research, and Evaluation (OPRE). 

the Administration for Children and 

Families (ACF): The Head Start CARES 

project uses a group-based randomized 

design to test the effects of three 

different evidence-based programs 

designed to improve the social and 

emotional development of children in 

Head Start classrooms. 

Data to assess impacts of the program 

models in preschool was collected 

through surveys with teachers and 

parents, as well as direct child 

assessments. Data to assess 

implementation of the program models 

in preschool was collected through 

surveys and interviews with teachers, 

local coaches, trainers and center staff. 

Data collection for both the impact and 

implementation studies occurred during 

the Head Start Year. The study sample 

involved 17 Head Start grantees/ 

delegate agencies, 104 centers, 307 

classrooms, 1,042 selected 3-year-old 

children and 2,885 selected 4-year-old 

children. 

The purpose of this request is to 

obtain an extension to finish impact 

data collection in the 2012 Follow-up 

Year (e.g., Kindergarten for the 4-yearolds). This data to assess impacts of the 

program models in the kindergarten 

year will be collected through teacher 

reports (surveys) and parent surveys. 

Respondents: The respondents for the 

activities under the extension request 

for Follow-Up year data collection will 

be parents of children and kindergarten 

teachers of children in the study. 

The annual burden estimates for both 

surveys covered by the extension are 

detailed below. 

ANNUAL BURDEN ESTIMATES—EXTENSION

Instrument 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated 

annual 

burden hours 

Teacher Report on Individual Children ............................................................ 608 1 0.33 201 

Follow-up Parent Survey ................................................................................. 608 1 0.33 201 

Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 402 

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23484 Federal Register / Vol. 77, No. 76 / Thursday, April 19, 2012 / Notices 

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: OPRE Reports Clearance Officer. 

All requests should be identified by the 

title of the information collection. Email 

address: 

OPREinfocollection@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 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, Email: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: April 12, 2012. 

Steven M. Hanmer, 

OPRE Reports Clearance Officer. 

[FR Doc. 2012–9303 Filed 4–18–12; 8:45 am] 

BILLING CODE 4184–22–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0357] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Device 

Decision Analysis: A Risk-Tolerance 

Pilot Study 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. 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 and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the survey entitled ‘‘Medical Device 

Decision Analysis: A Risk-Tolerance 

Pilot Study.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 18, 2012. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

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. 

‘‘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 provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

I. Background 

A recent study of obesity indicates 

that 35.5 percent of men and 35.8 

percent of women in America reported 

being obese in 2010. This represents an 

increase from 27.5 percent and 33.4 

percent in 2000 for men and women, 

respectively (Ref. 1). People who are 

obese are more likely to suffer from 

diabetes, cardiovascular disease, 

respiratory and metabolic disease, and 

sleep apnea, as well as other physical 

and psychological disabilities. By some 

estimates, as much as $140 billion were 

spent in 2008 to treat obesity-related 

diseases (Ref. 2). Studies have shown 

that weight loss can significantly reduce 

the burden of obesity-related 

comorbidities (Refs. 3 and 4), and that 

weight lost as a result of laparoscopic 

banding or other weight-loss surgeries 

positively impacts quality of life and 

burden of disease (Refs. 5 through 7). 

However, like any surgical procedure, 

these surgeries are associated with 

substantial risks, including risks of 

potentially life-threatening events (Ref. 

6), that patients and physicians must 

weigh against any potential benefits 

when making an informed treatment 

decision. 

With the assistance of advisory 

panels, FDA determines the acceptable 

risk threshold of a medical intervention 

against its effectiveness as demonstrated 

in clinical evidence. In addition, 

individual patients and patientadvocacy groups anecdotally express 

their opinions about their needs and 

tolerance for risks to FDA through 

letters and public testimonies during 

advisory panel meetings. To evaluate 

the scientific validity of systematically 

eliciting patient perspectives on 

outcomes associated with weight-loss 

devices, the Agency requests approval 

of a pilot survey to quantify obesity 

patients’ benefit-risk preferences. 

The choice-format preferenceelicitation survey will ask obese 

individuals (with a body mass index of 

30 kg/m2 or above) to evaluate a series 

of choices between pairs of hypothetical 

medical devices. Each hypothetical 

device will be defined by the amount 

and duration of weight loss, side effects, 

risks associated with hypothetical 

weight-loss devices, and the effect of the 

device on weight-related comorbidities. 

The survey was developed using 

findings from a literature review of the 

outcomes associated with weight-loss 

devices, interviews with obesity 

patients, and expert opinion. 

An invitation to the online survey 

will be sent to a sample of 1,000 obese 

adults in the United States. Among the 

adults who receive the invitation, about 

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