[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]


-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent        (in hr)         (in hr)
----------------------------------------------------------------------------------------------------------------
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.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           4,248
----------------------------------------------------------------------------------------------------------------


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]
BILLING CODE 4163-18-P