67092 Federal Register / Vol. 75, No. 210 / Monday, November 1, 2010 / Notices 

company by acquiring 100 percent of 

the voting shares of Cadence Financial 

Corporation, Starkville, Mississippi, and 

thereby indirectly acquire voting shares 

of Cadence Bank, N.A., Starkville, 

Mississippi. 

Board of Governors of the Federal Reserve 

System, October 27, 2010. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. 2010–27492 Filed 10–29–10; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60–Day–11–11AI] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 and 

send comments to Carol Walker, Acting 

CDC Reports Clearance Officer, 1600 

Clifton Road, MS–D74, Atlanta, GA 

30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited 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) ways to enhance 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. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Measuring Preferences for Quality of 

Life for Child Maltreatment—New— 

National Center for Injury Prevention 

and Control (NCIPC), Division of 

Violence Prevention (DVP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

Child maltreatment (CM) is a major 

public health problem in the United 

States, causing substantial morbidity 

and mortality (DHHS, 2010), and the 

prevalence for any of the three major 

types of CM (physical abuse, sexual 

abuse, and neglect) is estimated at 

approximately 28% (Hussey et al., 

2006). Additionally, the annual 

incidence of any type of CM among 

children and adolescents 0–17 has been 

estimated at nearly 14%, while physical 

and sexual abuse are estimated at 3.7% 

and 0.6%, respectively (Finkelhor et al., 

2005). CM has been shown to have 

lifelong adverse physical and mental 

health consequences for survivors 

(Felitti et al., 1998), including 

behavioral problems (Felitti et al. 1998; 

Repetti et al. 2002), mental health 

conditions such as post-traumatic stress 

disorder (PTSD) (Browne and Finkelhor, 

1986; Holmes and Sammel, 2005; 

Moeller and Bachman, 1993), increased 

trouble with interpersonal relationships 

(Fang and Corso, 2007), increased risk of 

chronic diseases (Browne and 

Finkelhor, 1986), and lasting impacts or 

disability from physical injury 

(Dominguez et al. 2001). The 

consequences of CM have both a direct 

impact, through reduced health, as well 

as an indirect impact, through reduced 

health-related quality of life (HRQoL, or 

simply QoL), the state of ‘‘utility’’ or 

satisfaction that a person experiences as 

a result of their health (Drummond et al. 

1997). 

The CDC requests approval of a 

survey-based study to measure the 

Health-Related Quality-of-Life (HRQoL) 

impacts resulting from child 

maltreatment (CM) using a quantitative, 

preference-based approach. The US 

Department of Health and Human 

Services, among many others, has 

identified child maltreatment as a 

serious U.S. public health problem with 

substantial long-term physical and 

psychological consequences. Despite 

considerable research on the 

consequences of CM in adult survivors, 

few studies have utilized standard 

HRQoL techniques and none have 

quantified childhood HRQoL impacts. 

This gap in the literature means the full 

burden of CM on HRQoL has not been 

measured, inhibiting the evaluation and 

comparison of CM intervention 

programs. This study will improve 

public health knowledge and economic 

evaluation of the HRQoL impacts of CM, 

including effects specific to juvenile and 

adolescent survivors, through the 

development and fielding a preferencebased survey instrument. 

CDC has developed a survey 

instrument to quantify the HRQoL 

impacts of child maltreatment following 

standardized methods. The survey was 

developed based on findings from a 

literature review of CM outcomes, focus 

groups with adult CM survivors, and 

expert review of outcomes by clinician 

consultants who work with survivors of 

CM or who are researchers in the field 

of CM. The survey is designed to 

quantify two types of data. The main 

objective is the HRQoL decrement 

attributable to CM, measured as the 

difference in HRQoL scores by CM 

survivorship history. A secondary 

objective is a statistical evaluation of 

these decrements, based on respondent 

preferences over a series of comparisons 

that will be shown to survey 

respondents. 

An invitation to the online survey 

will be fielded to a nationallyrepresentative sample of 2,700 U.S. 

adults. Among the adults who receive 

the invitation, 1,650 are expected to 

complete the consent form and 1,500 are 

expected to complete the survey. The 

survey will include HRQoL questions to 

capture the two types of data above, as 

well as select items on 

sociodemographics. Past exposure to 

CM will be measured using the Child 

Trauma Questionnaire (CTQ), the 

briefest and most nonintrusive set of 

scientifically validated questions to 

identify 5 types of past child abuse and 

neglect. 

Final results will provide an estimate 

of the HRQoL burden of child 

maltreatment in the United States. 

Analysis and results of the survey data 

will be used to inform the scientific and 

public health communities of the 

impacts of CM, and to evaluate and 

compare CM intervention programs. 

There is no cost to respondents other 

than their time. 

Respondents (forms listed in parentheses) Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

General national sample of adults age 18+ (survey invitation) ....................... 2,700 1 2/60 90 

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Federal Register / Vol. 75, No. 210 / Monday, November 1, 2010 / Notices 67093 

Respondents (forms listed in parentheses) Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

General national sample of adults age 18+ (consent form) ............................ 1,650 1 2/60 55 

General national sample of adults age 18+ (full survey) ................................ 1,500 1 25/60 625 

Total .......................................................................................................... ........................ ........................ ........................ 770 

Carol Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–27487 Filed 10–29–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Joint Meeting of the Anesthetic and 

Life Support Drugs Advisory 

Committee and the Drug Safety and 

Risk Management Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). At least one portion of the 

meeting will be closed to the public. 

Name of Committees: Anesthetic and Life 

Support Drugs Advisory Committee and the 

Drug Safety and Risk Management Advisory 

Committee. 

General Function of the Committees: To 

provide advice and recommendations to the 

Agency on FDA’s regulatory issues. 

Date and Time: The meeting will be held 

on December 2, 2010, from 8 a.m. to 4:30 

p.m. 

Location: The Marriott Inn and Conference 

Center, University of Maryland University 

College, The Ballroom, 3501 University Blvd. 

East, Adelphi, MD. The hotel telephone 

number is 301–985–7300. 

Contact Person: Kalyani Bhatt, Center for 

Drug Evaluation and Research, Food and 

Drug Administration, 10903 New Hampshire 

Ave., Bldg. 31, rm. 2417, Silver Spring, MD 

20993–0002, 301–796–9001, FAX: 301–847– 

8533, e-mail: kalyani.bhatt@fda.hhs.gov, or 

FDA Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), codes 3014512529 or 

3014512535. Please call the Information Line 

for up-to-date information on this meeting. A 

notice in the Federal Register about last 

minute modifications that impact a 

previously announced advisory committee 

meeting cannot always be published quickly 

enough to provide timely notice. Therefore, 

you should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn about 

possible modifications before coming to the 

meeting. 

Agenda: On December 2, 2010, the 

committees will begin with a closed session 

from 8 a.m. to 9:15 a.m. Following the closed 

session, from 9:15 a.m. to 4:30 p.m., the 

meeting will be open to the public. The 

committees will discuss new drug 

application (NDA) 201655, Oxymorphone 

HCl Extended-Release Tablets, Endo 

Pharmaceuticals, Inc., and its safety for the 

proposed indication of relief of moderate to 

severe pain in patients requiring continuous, 

around-the-clock opioid treatment for an 

extended period of time. The extendedrelease characteristics of this formulation are 

purportedly less easily defeated than other 

formulations of controlled-release 

oxymorphone. 

FDA intends to make background material 

available to the public no later than 2 

business days before the meeting. If FDA is 

unable to post the background material on its 

Web site prior to the meeting, the background 

material will be made publicly available at 

the location of the advisory committee 

meeting, and the background material will be 

posted on FDA’s Web site after the meeting. 

Background material is available at http:// 

www.fda.gov/AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the appropriate 

advisory committee link. 

Procedure: On December 2, 2010, from 9:15 

a.m. to 4:30 p.m., the meeting is open to the 

public. Interested persons may present data, 

information, or views, orally or in writing, on 

issues pending before the committee. Written 

submissions may be made to the contact 

person on or before November 17, 2010. Oral 

presentations from the public will be 

scheduled between approximately 1 p.m. and 

2 p.m. Those desiring to make formal oral 

presentations should notify the contact 

person and submit a brief statement of the 

general nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and an 

indication of the approximate time requested 

to make their presentation on or before 

November 8, 2010. Time allotted for each 

presentation may be limited. If the number of 

registrants requesting to speak is greater than 

can be reasonably accommodated during the 

scheduled open public hearing session, FDA 

may conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by November 9, 2010. 

Closed Presentation of Data: On December 

2, 2010, from 8 a.m. to 9:15 a.m., the meeting 

will be closed to permit discussion and 

review of trade secret and/or confidential 

information (5 U.S.C. 552b(c)(4)). During this 

session, the committee will discuss 

confidential protocol and methodology. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee meetings 

and will make every effort to accommodate 

persons with physical disabilities or special 

needs. If you require special accommodations 

due to a disability, please contact Kalyani 

Bhatt at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly conduct 

of its advisory committee meetings. Please 

visit our Web site at http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ucm111462.htm 

for procedures on public conduct during 

advisory committee meetings. 

Notice of this meeting is given under the 

Federal Advisory Committee Act (5 U.S.C. 

app. 2). 

Dated: October 26, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–27457 Filed 10–29–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–P–0517] 

Iceberg Water Deviating From Identity 

Standard; Temporary Permit for Market 

Testing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a temporary permit has been issued 

to Iceberg Canada Corp., to market test 

a product designated as ‘‘GLACE Rare 

Iceberg Water’’ that deviates from the 

U.S. standard of identity for bottled 

water. The purpose of the temporary 

permit is to allow the applicant to 

measure consumer acceptance of the 

product, identify mass production 

problems, and assess commercial 

feasibility. 

DATES: This permit is effective for 15 

months, beginning on the date the 

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