[Federal Register Volume 79, Number 45 (Friday, March 7, 2014)]
[Notices]
[Pages 13056-13057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04974]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-14-0904]
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 404-639-7570 or
send comments to Leroy Richardson, 1600 Clifton Road, MS D-74, Atlanta,
GA 30333 or send an email to [email protected].
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 (OMB No. 0920-0904, exp. 11/30/
2014)--Revision--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. Type 2 diabetes begins
when the body develops a resistance to insulin and no longer uses it
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. 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 clinical study centers that reflected the racial and ethnic
diversity of the U.S. Phases 1 (2000-2005) and 2 (2005-2010) produced
estimates of the prevalence and incidence of diabetes among youth age
<20 years, according to diabetes type, age, sex, and race/ethnicity,
and characterized selected acute and chronic complications of diabetes
and their risk factors, as well as the quality of life and quality of
health care. In Phases 1 and 2, the clinical centers and a data
coordinating center were funded through cooperative agreements. The
information collected at that time was not provided directly to CDC.
Phase 3 (2011-present) builds upon previous efforts. Five clinical
sites collect patient-level information that is compiled by a data
coordinating center. CDC obtained OMB approval to receive the
information in 2011 (SEARCH for Diabetes in Youth, OMB No. 0920-0904,
exp. 11/30/2014). Phase 3 includes a case registry of youth <20 years
of age who have been diagnosed with diabetes, and a longitudinal cohort
research study about SEARCH cases whose diabetes was incident in 2002
or later. To date, SEARCH Phase 3 has identified an average of 1,361
incident cases of diabetes among youth under 20 years each year of the
study and has completed an average of 1,088 participant surveys each
year (80% participation rate among registry study participants). As of
November 2013,
[[Page 13057]]
SEARCH Phase 3 has completed visits for 1,839 cohort study
participants.
CDC plans to continue information collection for two additional
years, with minor changes. Participants in the registry study will
continue to complete a Medication Inventory and an Initial Participant
Survey; however, the in-person study examination will be discontinued.
This change will result in a decrease in burden per respondent. CDC
estimates that each clinical site will identify and register an average
of 255 cases per year, for a total 1,275 cases across all sites.
No data collection changes are planned for the cohort study. CDC
estimates that each clinical site will conduct follow-up on an average
of 142 cases per year, for a total of 710 cases across all sites. The
items collected for each case include a Health Questionnaire (Youth
version), an additional Health Questionnaire (Parent version), Center
for Epidemiologic Study-Depression, Quality of Care, Pediatric Quality
of Life Survey (Peds QL), SEARCH Michigan Neuropathy Screening
Instrument, Diabetes Eating Survey, Low Blood Sugar Survey,
Supplemental Survey, Tanner Stage, Retinal Photo, Family Conflict
Survey, Pediatric Diabetes Quality of Life Scale, Physical Exam,
Specimen Collection, and Food Frequency Questionnaire.
Findings from the registry study will be used to estimate the
incidence of diabetes in youth in the U.S. Findings from the cohort
study will be used to estimate the prevalence and incidence of risk
factors and complications associated with diabetes in youth, including
chronic microvascular complications (retinopathy, nephropathy, and
autonomic neuropathy) and selected markers of macrovascular
complications (hypertension, arterial stiffness) of diabetes.
Participation is voluntary and there are no costs to respondents
other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hr) (in hr)
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SEARCH Registry Study Medication 1,275 1 5/60 106
Participants. Inventory. 1,275 1 10/60 213
Initial
Participant
Survey.
SEARCH Cohort Study Health 710 1 15/60 178
Participants. Questionnaire- 710 1 15/60 178
Youth.
Health
Questionnaire-
Parent.
CES-Depression.. 710 1 4/60 47
Quality of Care. 710 1 13/60 154
Peds QL......... 710 1 5/60 59
SEARCH MNSI 710 1 10/60 118
Neuropathy.
Diabetes Eating 710 1 5/60 59
Survey.
Low Blood Sugar 710 1 5/60 59
Survey.
Supplemental 710 1 10/60 118
Survey.
Tanner Stage.... 710 1 5/60 59
Retinal Photo... 710 1 15/60 178
Family Conflict 710 1 5/60 59
Survey.
Pediatric 710 1 5/60 59
Diabetes QOL
Scale.
Physical Exam... 710 1 3 2,130
Specimen 710 1 20/60 237
Collection.
Food Frequency 710 1 20/60 237
Questionnaire.
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Total..................... ................ .............. .............. .............. 4,248
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-04974 Filed 3-6-14; 8:45 am]
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