[Federal Register Volume 79, Number 90 (Friday, May 9, 2014)]
[Notices]
[Pages 26760-26762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10618]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-14-0904]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 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 (OMB No. 0920-0904, exp. 11/30/
2014)--Revision--National Center for Chronic Disease Prevention and 
Health

[[Page 26761]]

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. 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, 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. The total estimated annualized burden hours are 
4,248.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent        (in hr)
----------------------------------------------------------------------------------------------------------------
SEARCH Registry Study Participants....  Medication Inventory....           1,275               1            5/60
                                        Initial Participant                1,275               1           10/60
                                         Survey.
SEARCH Cohort Study Participants......  Health Questionnaire-                710               1           15/60
                                         Youth.
                                        Health Questionnaire-                710               1           15/60
                                         Parent.
                                        CES-Depression..........             710               1            4/60
                                        Quality of Care.........             710               1           13/60
                                        Peds QL.................             710               1            5/60
                                        SEARCH MNSI Neuropathy..             710               1           10/60
                                        Diabetes Eating Survey..             710               1            5/60
                                        Low Blood Sugar Survey..             710               1            5/60
                                        Supplemental Survey.....             710               1           10/60
                                        Tanner Stage............             710               1            5/60
                                        Retinal Photo...........             710               1           15/60
                                        Family Conflict Survey..             710               1            5/60
                                        Pediatric Diabetes QOL               710               1            5/60
                                         Scale.
                                        Physical Exam...........             710               1               3
                                        Specimen Collection.....             710               1           20/60
                                        Food Frequency                       710               1           20/60
                                         Questionnaire.
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[[Page 26762]]

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. 2014-10618 Filed 5-8-14; 8:45 am]
BILLING CODE 4163-18-P