Published 30d FRN

32702

Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–17–0904]

asabaliauskas on DSKBBXCHB2PROD with NOTICES

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).

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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

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collect information from participants
related to diabetes diagnosis and will
ask participants identified with incident
diabetes in 2016 to complete an inperson 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 Populationbased 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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Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices

32703

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
respondents

Type of respondent
Incident case ...................................................

1,511

1
1

Incident case in 2016 who complete survey ..

823

Prevalent case ................................................

776

1
1
1

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–17–17NE]

Agency Forms Undergoing Paperwork
Reduction Act Review

asabaliauskas on DSKBBXCHB2PROD with NOTICES

Number of
responses per
respondent

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,

VerDate Sep<11>2014

17:45 Jul 14, 2017

Jkt 241001

Form name
Medical Inventory ...........................................
Initial Participant Survey Incident case (adult
and parent).
Physical Exam ................................................
Specimen collection .......................................
Initial Participant Survey, Prevalent case
(adult and parent).

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
Survey of Engineered Nanomaterial
Occupational Safety and Health
Practices—New—National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
As mandated in the Occupational
Safety and Health Act of 1970 (PL 91–
596), NIOSH’s mission is to conduct
research and investigations on workrelated disease and injury and to
disseminate information for preventing
identified workplace hazards (Sections
20 (a)(1) and (d)). This dual
responsibility recognizes the need to
translate research into workplace
application if it is to impact worker
safety and well-being. The goal of this
project is to assess the relevance and
impact of NIOSH’s contribution to
guidelines and risk mitigation practices
for safe handling of engineered
nanomaterials in the workplace. The
intended use of this data is to inform
NIOSH’s research agenda to enhance its
relevance and impact on worker safety
and health in the context of engineered
nanomaterials.

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Average
burden
per response
5/60
10/60
1.5
20/60
10/60

The research under this project will
survey companies who manufacture,
distribute, fabricate, formulate, use or
provide services related to engineered
nanomaterials. The analysis will
describe the survey sample, response
rates, and types of company by industry
and size. Further analysis will focus on
identifying the types of engineered
nanomaterials being used in industry
and the types of occupational safety and
health practices being implemented.
The analysis will be used to develop a
final report which evaluates the
influence of NIOSH products, services,
and outputs on industry occupational
safety and health practices.
Under this project, the following
activities and data collections will be
conducted:
(1) Company Pre-calls. Sampled
companies will be contacted to identify
the person who will complete the
survey and to ascertain whether or not
the company handles engineered
nanomaterials.
(2) Survey. A web-based
questionnaire, with a mail option, will
be administered to companies. The
purpose of the survey is to learn directly
from companies about their use of
NIOSH materials and their occupational
safety and health practices concerning
engineered nanomaterials.
A sample of 600 companies will be
compiled from lists of industry
associations, research reports, marketing
databases, and web-based searches. Of
the 600 selected companies we
anticipate that 500 will complete the
survey within two years. The company
pre-call is expected to require five
minutes to complete. The survey is
expected to require 20 minutes to
complete; including the time it may take
respondents to look-up and retrieve
needed information. The estimated
annualized burden hours for the
respondents’ time to participate in this
information collection is 109 hours.

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