[Federal Register Volume 76, Number 98 (Friday, May 20, 2011)]
[Notices]
[Pages 29245-29246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-12468]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-11-11CB]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to [email protected]. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-5806.
Written comments should be received within 30 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. 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 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.
CDC proposes to collect de-identified, case-level information from
five SEARCH sites during Phase 3 of the SEARCH for Diabetes in Youth
Study. 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.
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 inpatient
survey, core information, medications, and physical exam data. 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 health
questionnaires for youth and parents, physical exam information, and
surveys about eating behavior, blood sugar, neuropathy, family
relationships, and quality of life. Information will also be collected
to monitor 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 total estimated annualized burden is 2,132 hours. There are no
costs to respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average
Type of respondents Number of responses per Form name burden per
respondents respondent response
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SEARCH Clinical Sites: Registry Study. 5 255 Extended Core........... 10/60
Medication Inventory.... 5/60
.............. .............. Inpatient Survey........ 10/60
.............. .............. Specimen Collection 5/60
(Registry).
.............. .............. Physical Exam (Registry) 5/60
SEARCH Clinical Sites: Cohort Study... 5 142 Health Questionnaire- 15/60
Youth. 15/60
Health Questionnaire-
Parent.
.............. .............. CES-Depression.......... 4/60
.............. .............. Medical Record 10/60
Validation.
.............. .............. Quality of Care......... 13/60
.............. .............. Peds QL................. 5/60
.............. .............. SEARCH MNSI Neuropathy.. 5/60
.............. .............. Diabetes Eating Survey.. 5/60
[[Page 29246]]
.............. .............. Low Blood Sugar Survey.. 5/60
.............. .............. Supplemental............ 10/60
.............. .............. Tanner Stage............ 5/60
.............. .............. Retinal Photo........... 5/60
.............. .............. Family Conflict......... 5/60
.............. .............. Pediatric Diabetes QOL 5/60
Scale.
.............. .............. Physical Exam........... 5/60
.............. .............. Specimen Collection..... 5/60
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SEARCH Clinical Sites: Monitoring..... 5 13 Unanticipated Occurrence/ 5/60
Condition Reporting
Form.
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Dated: May 16, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-12468 Filed 5-19-11; 8:45 am]
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