81 FR 88685 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 236 (December 8, 2016)

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed revision of the ``SEARCH for Diabetes in Youth Study,'' a national multi-center study aimed at understanding more about diabetes among children and young adults in the United States.

[Federal Register Volume 81, Number 236 (Thursday, December 8, 2016)]
[Notices]
[Pages 88685-88687]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29428]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-0904; Docket No. CDC-2016-0117]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
revision of the ``SEARCH for Diabetes in Youth Study,'' a national 
multi-center study aimed at understanding more about diabetes among 
children and young adults in the United States.

DATES: Written comments must be received on or before February 6, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0117 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (regulations.gov) or by U.S. mail to the 
address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    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; (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; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    SEARCH for Diabetes in Youth Study (OMB Control No. 0920-0904, 
Expires 8/31/2017)--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)

[[Page 88686]]

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 will no longer be collected. The total estimated 
annualized burden for this information collection is 1,371 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 130 hours. This is a new data collection 
instrument.
    The SEARCH for Diabetes in Youth Study was initially approved with 
4,248 annualized burden hours. In this Revision, we request approval 
for 1,878 annualized burden hours (a net reduction of 2,369 annualized 
burden hours). The estimated annualized burden per participant 
respondent is reduced by 3.2 hours since the CDC is no longer funding 
the cohort component. The total annualized burden for this study is 
1,878.
    There are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of
      Type of respondents           Form name        Number of     responses per  Average burden   Total burden
                                                    respondents     respondent     per response     (in hours)
----------------------------------------------------------------------------------------------------------------
Incident cases................  Medical                    1,511               1            5/60             126
                                 Inventory.                1,511               1           10/60             252
                                Initial
                                 Participant
                                 Survey.
Incident cases in 2016 who      Physical exam...             823               1           80/60           1,097
 complete the survey.           Specimen                     823               1           20/60             274
                                 collection.
Prevalent cases...............  Initial                      776               1           10/60             129
                                 Participant
                                 Survey.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,878
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[[Page 88687]]

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. 2016-29428 Filed 12-7-16; 8:45 am]
 BILLING CODE 4163-18-P