[Federal Register Volume 82, Number 135 (Monday, July 17, 2017)]
[Notices]
[Pages 32702-32703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14913]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-0904]


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 Control Number 0920-0904, 
Expiration Date 08/31/2017)--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 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. Phase 3 (2010-2015) built upon the activities in Phase 1 
and 2 and added a cohort component to collect information on estimate 
the prevalence and incidence of risk factors and complications, 
including chronic microvascular (retinopathy, nephropathy, and 
autonomic neuropathy) and selected markers of macrovascular 
complications (hypertension, arterial stiffness) of diabetes.
    SEARCH Phase 4 (2015-2020) continues the activities of the SEARCH 
Registry Study via cooperative agreements with the clinical sites, data 
coordinating center, and CDC. Respondents will be youth <20 years of 
age who have been diagnosed with diabetes. Information will be 
collected from the study participants by five clinical sites and 
transmitted to the Coordinating Center for the study, each funded 
through a cooperative agreement. Information collection will support a 
case registry that can be used to estimate the incidence and prevalence 
of diabetes in youth in the U.S. The registry study will continue to 
collect information from participants related to diabetes diagnosis and 
will ask participants identified with incident diabetes in 2016 to 
complete an in-person study examination. CDC is no longer funding the 
cohort component of the SEARCH for Diabetes in Youth Study.
    SEARCH Phase 3 identified an average of 1,361 incident cases of 
diabetes among youth under 20 years each year of the study and 
completed an average of 1,088 participant surveys each year (80% 
participation rate among registry study participants).
    Respondents will be the Population-based Diabetes in Youth (SEARCH 
for Diabetes in Youth Phase 4) study participants. The information 
collection will include:
    1. Incident diabetes cases:
     Collection of 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 302 to 303 cases per 
year, for a total of 1,511 cases across all sites. There are no changes 
for the Medication Inventory Form. The Initial Participant Survey form 
has been revised to eliminate questions that were not useful to the 
researchers and to improve readability and understanding for the 
participants. The overall burden for the form has not changed. The 
total estimated annualized burden for this information collection is 
378 hours.
     Physical exam and specimen collection for the 2016 
incident cases. CDC estimates that each clinical site will identify and 
register 1,511 cases during this incident year. Of these cases, CDC 
anticipants 80% will complete the Initial Participant Survey and be 
invited for an in-person visit. Of those, we anticipate a 65 to 70% 
response rate and complete 823 in-person visits. The Physical Exam Form 
has not changed. There was a change to the Specimen Collection Form 
since a spot urine sample will no longer be collected. The total 
estimated annualized burden for this information collection is 1,509 
hours.
    2. Prevalent diabetes cases:
     Collection of information on prevalent cases of diagnosed 
diabetes among youth <20 years. CDC estimates that the clinical sites 
will identify 776 cases. The items collected for each case include an 
Initial Participant Survey. The total estimated annualized burden for 
this information collection is 129 hours. This is a new data collection 
instrument.
    The estimated annualized burden per participant respondent is 
reduced by 3.2 hours since the CDC is no longer funding the cohort 
component.

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    The total annualized burden for this study is 2,016 hours. There 
are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                           Number of                                  Average
          Type of respondent               Number of     responses per          Form name           burden per
                                          respondents     respondent                                 response
----------------------------------------------------------------------------------------------------------------
Incident case.........................           1,511               1  Medical Inventory.......            5/60
                                                                     1  Initial Participant                10/60
                                                                         Survey Incident case
                                                                         (adult and parent).
Incident case in 2016 who complete                 823               1  Physical Exam...........             1.5
 survey.                                                             1  Specimen collection.....           20/60
Prevalent case........................             776               1  Initial Participant                10/60
                                                                         Survey, Prevalent case
                                                                         (adult and parent).
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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. 2017-14913 Filed 7-14-17; 8:45 am]
 BILLING CODE 4163-18-P