Proposed Data Collections Submitted for Public Comment and Recommendations, 67092-67093 [2010-27487]
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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]
mstockstill on DSKH9S0YB1PROD with NOTICES
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
Number of
respondents
Respondents (forms listed in parentheses)
General national sample of adults age 18+ (survey invitation) .......................
VerDate Mar<15>2010
16:44 Oct 29, 2010
Jkt 223001
PO 00000
Frm 00014
Fmt 4703
Sfmt 4703
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.
Number of
responses per
respondent
2,700
E:\FR\FM\01NON1.SGM
1
01NON1
Average
burden per
response
(in hours)
2/60
Total burden
(in hours)
90
67093
Federal Register / Vol. 75, No. 210 / Monday, November 1, 2010 / Notices
Number of
responses per
respondent
Number of
respondents
Respondents (forms listed in parentheses)
Average
burden per
response
(in hours)
Total burden
(in hours)
General national sample of adults age 18+ (consent form) ............................
General national sample of adults age 18+ (full survey) ................................
1,650
1,500
1
1
2/60
25/60
55
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.
mstockstill on DSKH9S0YB1PROD with NOTICES
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
VerDate Mar<15>2010
16:44 Oct 29, 2010
Jkt 223001
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 https://
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
PO 00000
Frm 00015
Fmt 4703
Sfmt 4703
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 https://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]
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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.
The Food and Drug
Administration (FDA) is announcing
that a temporary permit has been issued
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a product designated as ‘‘GLACE Rare
Iceberg Water’’ that deviates from the
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DATES: This permit is effective for 15
months, beginning on the date the
SUMMARY:
E:\FR\FM\01NON1.SGM
01NON1
]]>Agencies
[Federal Register Volume 75, Number 210 (Monday, November 1, 2010)]
[Notices]
[Pages 67092-67093]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-27487]
=======================================================================
-----------------------------------------------------------------------
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
preference-based 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 nationally-
representative 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.
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Respondents (forms listed in parentheses) respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
General national sample of adults age 18+ 2,700 1 2/60 90
(survey invitation)............................
[[Page 67093]]
General national sample of adults age 18+ 1,650 1 2/60 55
(consent form).................................
General national sample of adults age 18+ (full 1,500 1 25/60 625
survey)........................................
---------------------------------------------------------------
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
