Proposed Data Collections Submitted for Public Comment and Recommendations, 7859-7860 [2011-3081]
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7859
Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondent
Number of
respondents
Form name
Office-based physicians/CHC providers/
staff.
Office/CHC staff .......................................
Office-based physicians/CHC providers/
staff.
Office-based physicians ...........................
Office-based physicians ...........................
Pretest NAMCS forms:
Office-based physicians ...........................
Office-based physicians ...........................
Office-based physicians/staff ...................
1,017
30
11/60
Pulling, re-filing Patient Record form
(NAMCS–30).
Asthma Supplement .......................................
893
30
1/60
669
1
15/60
EMR/EHR Mail Survey ...................................
Physician Workflow Survey ............................
5,460
2,982
1
1
20/60
20/60
Physician Induction Interview (NAMCS–1) ....
Asthma Supplement .......................................
Patient Record form (NAMCS–30) ................
100
100
100
1
1
30
35/60
15/60
14/60
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
[FR Doc. 2011–3083 Filed 2–10–11; 8:45 am]
Proposed Project
BILLING CODE 4163–18–P
SEARCH for Diabetes in Youth
Study—New—Division of Diabetes
Translation, National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Centers for Disease Control and
Prevention
Background and Brief Description
[60Day–11–11CB]
jlentini on DSKJ8SOYB1PROD 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 or send
comments to Carol E. Walker, CDC
Acting Reports Clearance Officer, 1600
Clifton Road, MS D–74, 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
VerDate Mar<15>2010
18:55 Feb 10, 2011
Jkt 223001
Hours per
response
Patient Record form (NAMCS–30) ................
Dated: February 7, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Number of
responses per
respondent
Diabetes is one of the most common
chronic diseases among children in the
United States. When diabetes strikes
during childhood, it is routinely
assumed to be type 1, or juvenile-onset,
diabetes. Type 1 diabetes (T1D)
develops when the body’s immune
system destroys pancreatic cells that
make the hormone insulin that regulates
blood sugar. People with type 1 diabetes
must have daily insulin injections to
survive. In the last two decades, type 2
diabetes (T2D), formerly known as
adult-onset diabetes, has been reported
among U.S. children and adolescents
with increasing frequency. Type 2
diabetes begins when the body develops
a resistance to insulin and no longer
uses the insulin properly. As the need
for insulin rises, the pancreas gradually
loses its ability to produce sufficient
amounts of insulin to regulate blood
sugar.
Reports of increasing frequency of
both type 1 and type 2 diabetes in youth
have been among the most concerning
aspects of the evolving diabetes
epidemic. Unfortunately, reliable data
on changes over time in the U.S., or
even how many children in the U.S. had
type 1 or type 2 diabetes, were lacking.
In response to this growing public
health concern, the Centers for Disease
Control and Prevention (CDC) and the
National Institutes of Health (NIH)
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
funded the SEARCH for Diabetes in
Youth Study.
The SEARCH for Diabetes in Youth
Study began in 2000 as a multi-center,
epidemiological study, conducted in six
geographically dispersed Study Centers
that reflected the racial and ethnic
diversity of the U.S. Phases 1 (2000–
2005) and 2 (2005–2010) were designed
collaboratively by the research sites to
produce estimates of the prevalence and
incidence of diabetes among youth age
< 20 years, according to diabetes type,
age, sex, and race/ethnicity, and to
characterize selected acute and chronic
complications of diabetes and their risk
factors, as well as the quality of life and
quality of health care. Phases 1 and 2 of
SEARCH have contributed substantially
to understanding of the etiologic and
clinical dimensions of childhood
diabetes that relate to classification of
diabetes. However, critical questions
remain regarding ongoing trends in
incidence of childhood diabetes, as well
as the rationale and sustainability of
public health surveillance systems for
diabetes in youth.
Phase 3 of the SEARCH for Diabetes
in Youth Study will build on previous
efforts, with some changes to the data
collection procedures developed during
Phases 1 and 2. Phase 3 brings together
major and timely facets of childhood
diabetes research: An epidemiologic
component that assesses temporal
trends in the incidence of diabetes in
youth; a pathophysiologic component
addressing the natural history of
diabetes in youth; a health services
research component to evaluate the
processes and quality of care for youth
with diabetes; and a public health
perspective on case classification of
diabetes in youth.
As authorized by section 301 of the
Public Health Service Act (42 U.S.C.
241), CDC seeks OMB approval to
collect de-identified case-level
information from SEARCH study sites.
E:\FR\FM\11FEN1.SGM
11FEN1
7860
Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Notices
Information will be collected for three
years through a data collection
contractor, which will serve as the
SEARCH study Coordinating Center.
Data will be transmitted electronically
to the Coordinating Center through a
secure, dedicated Web site. Information
can be entered and transmitted at any
time. The information collection has
three components:
The Registry Study will collect
information on newly diagnosed
incident diabetes cases in youth age
< 20 years. CDC estimates that each
clinical site will identify and register an
average of 255 cases per year. The items
collected for each case include an
Extended Core, Medication Inventory,
Inpatient Survey, Specimen Collection
(Registry version), and Physical Exam
(Registry version). The total estimated
Information will also be collected for
the purpose of monitoring unanticipated
occurrences and conditions. CDC
estimates that each site will report an
average of 13 unanticipated occurrences
per year.
Respondents will be the five study
sites funded for SEARCH Phase 3.
Participation in the data collection is
required for the study sites, but
participation in the SEARCH study is
voluntary for individuals who are
followed at those sites. The estimated
annualized burden per study site is
426.4 hours. The total estimated
annualized burden for all sites is 2,132
hours.
There are no costs to respondents
other than their time.
annualized burden for this information
collection is 744 hours.
The Cohort Study is a longitudinal
research study about SEARCH cases
whose diabetes was incident in 2002 or
later. CDC estimates that each clinical
site will conduct follow-up on an
average of 142 cases per year. The items
collected for each case include a Health
Questionnaire (Youth version), an
additional Health Questionnaire (Parent
version), CES—Depression, Medical
Record Validation, Quality of Care, Peds
QL, SEARCH MNSI Neuropathy,
Diabetes Eating Survey, Low Blood
Sugar Survey, Supplemental Survey,
Tanner Stage, Retinal Photo, Family
Conflict Survey, Pediatric Quality of
Life Scale, Physical Exam, and
Specimen Collection.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
SEARCH
Study).
SEARCH
Study).
Clinical
Sites
Clinical
Sites
Total burden
(in hours)
Extended Core .................................
5
255
10/60
213
(Cohort
Medication Inventory ........................
Inpatient Survey ...............................
Specimen Collection (Registry) ........
Physical Exam (Registry) .................
Health Questionnaire—Youth ..........
........................
........................
........................
........................
5
........................
........................
........................
........................
142
5/60
10/60
5/60
5/60
15/60
106
213
106
106
178
Health Questionnaire—Parent .........
CES–Depression ..............................
Medical Record Validation ...............
Quality of Care .................................
Peds QL ...........................................
SEARCH MNSI Neuropathy ............
Diabetes Eating Survey ...................
Low Blood Sugar Survey .................
Supplemental ...................................
Tanner Stage ...................................
Retinal Photo ....................................
Family Conflict ..................................
Pediatric Diabetes QOL Scale .........
Physical Exam ..................................
Specimen Collection ........................
Unanticipated Occurrence/Condition
Reporting Form.
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
5
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
13
15/60
4/60
10/60
13/60
5/60
5/60
5/60
5/60
10/60
5/60
5/60
5/60
5/60
5/60
5/60
5/60
178
47
118
154
59
59
59
59
118
59
59
59
59
59
59
5
...........................................................
........................
........................
........................
2,132
Total ...........................................
Dated: February 7, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2011–3081 Filed 2–10–11; 8:45 am]
Centers for Disease Control and
Prevention
BILLING CODE 4163–18–P
[60Day–11–11CD]
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
VerDate Mar<15>2010
Average
burden per
response
(Registry
SEARCH Clinical Sites (Monitoring)
jlentini on DSKJ8SOYB1PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Form name
18:55 Feb 10, 2011
Jkt 223001
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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 E. Walker, CDC
Acting Reports Clearance Officer, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an e-mail to
omb@cdc.gov.
E:\FR\FM\11FEN1.SGM
11FEN1
]]>Agencies
[Federal Register Volume 76, Number 29 (Friday, February 11, 2011)]
[Notices]
[Pages 7859-7860]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3081]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-11-11CB]
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 or
send comments to Carol E. Walker, CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS D-74, 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
SEARCH for Diabetes in Youth Study--New--Division of Diabetes
Translation, National Center for Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Diabetes is one of the most common chronic diseases among children
in the United States. When diabetes strikes during childhood, it is
routinely assumed to be type 1, or juvenile-onset, diabetes. Type 1
diabetes (T1D) develops when the body's immune system destroys
pancreatic cells that make the hormone insulin that regulates blood
sugar. People with type 1 diabetes must have daily insulin injections
to survive. In the last two decades, type 2 diabetes (T2D), formerly
known as adult-onset diabetes, has been reported among U.S. children
and adolescents with increasing frequency. Type 2 diabetes begins when
the body develops a resistance to insulin and no longer uses the
insulin properly. As the need for insulin rises, the pancreas gradually
loses its ability to produce sufficient amounts of insulin to regulate
blood sugar.
Reports of increasing frequency of both type 1 and type 2 diabetes
in youth have been among the most concerning aspects of the evolving
diabetes epidemic. Unfortunately, reliable data on changes over time in
the U.S., or even how many children in the U.S. had type 1 or type 2
diabetes, were lacking. In response to this growing public health
concern, the Centers for Disease Control and Prevention (CDC) and the
National Institutes of Health (NIH) funded the SEARCH for Diabetes in
Youth Study.
The SEARCH for Diabetes in Youth Study began in 2000 as a multi-
center, epidemiological study, conducted in six geographically
dispersed Study Centers that reflected the racial and ethnic diversity
of the U.S. Phases 1 (2000-2005) and 2 (2005-2010) were designed
collaboratively by the research sites to produce estimates of the
prevalence and incidence of diabetes among youth age < 20 years,
according to diabetes type, age, sex, and race/ethnicity, and to
characterize selected acute and chronic complications of diabetes and
their risk factors, as well as the quality of life and quality of
health care. Phases 1 and 2 of SEARCH have contributed substantially to
understanding of the etiologic and clinical dimensions of childhood
diabetes that relate to classification of diabetes. However, critical
questions remain regarding ongoing trends in incidence of childhood
diabetes, as well as the rationale and sustainability of public health
surveillance systems for diabetes in youth.
Phase 3 of the SEARCH for Diabetes in Youth Study will build on
previous efforts, with some changes to the data collection procedures
developed during Phases 1 and 2. Phase 3 brings together major and
timely facets of childhood diabetes research: An epidemiologic
component that assesses temporal trends in the incidence of diabetes in
youth; a pathophysiologic component addressing the natural history of
diabetes in youth; a health services research component to evaluate the
processes and quality of care for youth with diabetes; and a public
health perspective on case classification of diabetes in youth.
As authorized by section 301 of the Public Health Service Act (42
U.S.C. 241), CDC seeks OMB approval to collect de-identified case-level
information from SEARCH study sites.
[[Page 7860]]
Information will be collected for three years through a data collection
contractor, which will serve as the SEARCH study Coordinating Center.
Data will be transmitted electronically to the Coordinating Center
through a secure, dedicated Web site. Information can be entered and
transmitted at any time. The information collection has three
components:
The Registry Study will collect information on newly diagnosed
incident diabetes cases in youth age < 20 years. CDC estimates that
each clinical site will identify and register an average of 255 cases
per year. The items collected for each case include an Extended Core,
Medication Inventory, Inpatient Survey, Specimen Collection (Registry
version), and Physical Exam (Registry version). The total estimated
annualized burden for this information collection is 744 hours.
The Cohort Study is a longitudinal research study about SEARCH
cases whose diabetes was incident in 2002 or later. CDC estimates that
each clinical site will conduct follow-up on an average of 142 cases
per year. The items collected for each case include a Health
Questionnaire (Youth version), an additional Health Questionnaire
(Parent version), CES--Depression, Medical Record Validation, Quality
of Care, Peds QL, SEARCH MNSI Neuropathy, Diabetes Eating Survey, Low
Blood Sugar Survey, Supplemental Survey, Tanner Stage, Retinal Photo,
Family Conflict Survey, Pediatric Quality of Life Scale, Physical Exam,
and Specimen Collection.
Information will also be collected for the purpose of monitoring
unanticipated occurrences and conditions. CDC estimates that each site
will report an average of 13 unanticipated occurrences per year.
Respondents will be the five study sites funded for SEARCH Phase 3.
Participation in the data collection is required for the study sites,
but participation in the SEARCH study is voluntary for individuals who
are followed at those sites. The estimated annualized burden per study
site is 426.4 hours. The total estimated annualized burden for all
sites is 2,132 hours.
There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average
Type of respondents Form name Number of responses per burden per Total burden
respondents respondent response (in hours)
----------------------------------------------------------------------------------------------------------------
SEARCH Clinical Sites Extended Core... 5 255 10/60 213
(Registry Study).
Medication .............. .............. 5/60 106
Inventory.
Inpatient Survey .............. .............. 10/60 213
Specimen .............. .............. 5/60 106
Collection
(Registry).
Physical Exam .............. .............. 5/60 106
(Registry).
SEARCH Clinical Sites (Cohort Health 5 142 15/60 178
Study). Questionnaire--
Youth.
Health .............. .............. 15/60 178
Questionnaire--
Parent.
CES-Depression.. .............. .............. 4/60 47
Medical Record .............. .............. 10/60 118
Validation.
Quality of Care. .............. .............. 13/60 154
Peds QL......... .............. .............. 5/60 59
SEARCH MNSI .............. .............. 5/60 59
Neuropathy.
Diabetes Eating .............. .............. 5/60 59
Survey.
Low Blood Sugar .............. .............. 5/60 59
Survey.
Supplemental.... .............. .............. 10/60 118
Tanner Stage.... .............. .............. 5/60 59
Retinal Photo... .............. .............. 5/60 59
Family Conflict. .............. .............. 5/60 59
Pediatric .............. .............. 5/60 59
Diabetes QOL
Scale.
Physical Exam... .............. .............. 5/60 59
Specimen .............. .............. 5/60 59
Collection.
SEARCH Clinical Sites Unanticipated 5 13 5/60 5
(Monitoring). Occurrence/
Condition
Reporting Form.
---------------------------------------------------------------------------------
Total..................... ................ .............. .............. .............. 2,132
----------------------------------------------------------------------------------------------------------------
Dated: February 7, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2011-3081 Filed 2-10-11; 8:45 am]
BILLING CODE 4163-18-P
