[Federal Register Volume 76, Number 29 (Friday, February 11, 2011)]
[Notices]
[Pages 7859-7860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-3081]


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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 
[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--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
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    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