[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
----------------------------------------------------------------------------------------------------------------
                                                           Number of                                  Average
          Type of respondents              Number of     responses per          Form name           burden per
                                          respondents     respondent                                 response
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
SEARCH Clinical Sites: Monitoring.....               5              13  Unanticipated Occurrence/           5/60
                                                                         Condition Reporting
                                                                         Form.
----------------------------------------------------------------------------------------------------------------


    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]
BILLING CODE 4163-18-P