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progress towards national public health
goals. Participation is voluntary and
there is no cost to respondents other

than their time. The total estimated
annualized burden hours are 8,735.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Persons Screened ..........................................
Eligible Participants .........................................

Eligibility Screener ..........................................
Behavioral Assessment for MSM ...................
Behavioral Assessment for IDU .....................
Behavioral Assessment for HET ....................
Recruiter Debriefing .......................................

Peer Recruiters ...............................................

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. 2016–29399 Filed 12–7–16; 8:45 am]
BILLING CODE 4163–18–P

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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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.
SUMMARY:

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Number of
respondents

Type of respondent

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• 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

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13,142
3,667
3,667
3,667
3,667

Number of
responses per
respondent
1
1
1
1
1

Average
burden per
response
(in hr)
5/60
30/60
54/60
39/60
2/60

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)

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Federal Register / Vol. 81, No. 236 / Thursday, December 8, 2016 / Notices

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

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.

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 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

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response

Total burden
(in hours)

Type of respondents

Form name

Incident cases ...................................
Incident cases in 2016 who complete the survey.
Prevalent cases ................................

Medical Inventory .............................
Initial Participant Survey ..................
Physical exam ..................................
Specimen collection .........................
Initial Participant Survey ..................

1,511
1,511
823
823
776

1
1
1
1
1

5/60
10/60
80/60
20/60
10/60

126
252
1,097
274
129

Total ...........................................

...........................................................

........................

........................

........................

1,878

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Federal Register / Vol. 81, No. 236 / Thursday, December 8, 2016 / Notices
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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

You may submit comments,
identified by CDC–2016–0090 and
Docket Number NIOSH 288–A, by either
of the following two methods:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: National Institute for
Occupational Safety and Health, NIOSH
Docket Office, 1090 Tusculum Avenue,
MS C–34, Cincinnati, Ohio 45226–1998.

ADDRESSES:

Dated: December 5, 2016.
Frank Hearl,
Chief of Staff, National Institute for
Occupational Safety and Health, Centers for
Disease Control and Prevention.

Centers for Disease Control and
Prevention
[CDC–2016–0090; Docket Number NIOSH
288–A]

[FR Doc. 2016–29411 Filed 12–7–16; 8:45 am]

A Performance Test Protocol for
Closed System Transfer Devices Used
During Pharmacy Compounding and
Administration of Hazardous Drugs;
Extension of Comment Period
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice and extension of
comment period.
AGENCY:

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request

On September 15, 2016 the
Director of the National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
published a notice in the Federal
Register [81 FR 63482] announcing a
public meeting and request for public
comment on a draft testing protocol.
Written comments were to be received
by December 7, 2016. In response to a
request from interested parties, NIOSH
has extended the comment period until
June 7, 2017. The longer timeframe will
allow companies to acquire the
proposed challenge agents and test their
CSTDs with the proposed universal
CSTD performance test protocol.
DATES: NIOSH is extending the
comment period on the document
published September 15, 2016 [81 FR
63482]. Electronic or written comments
must be received by June 7, 2017.
FOR FURTHER INFORMATION CONTACT:
Deborah V. Hirst, NIOSH, Alice
Hamilton Laboratories, 1090 Tusculum
Avenue, MS–R–5, Cincinnati, Ohio
45226, telephone (513) 841–4141 (not a
toll free number), Email: DHirst@
cdc.gov.
SUMMARY:

BILLING CODE 4163–19–P

Title: Head Start Family and Child
Experiences Survey (FACES).
OMB No.: 0970–0151.
Description: The Office of Planning,
Research and Evaluation (OPRE),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS), is
proposing to collect data for a new
round of the Head Start Family and
Child Experiences Survey (FACES).
Featuring a new ‘‘Core Plus’’ study
design, FACES will provide data on a
set of key indicators, including
information for performance measures.
The design allows for more rapid and
frequent data reporting (Core studies)
and serves as a vehicle for studying
more complex issues and topics in
greater detail and with increased
efficiency (Plus studies).
The FACES Core study will assess the
school readiness skills of Head Start
children, survey their parents, and ask
their Head Start teachers to rate
children’s social and emotional skills.
In addition, FACES will include
observations in Head Start classrooms,
and program director, center director,
and teacher surveys. FACES Plus
studies include additional survey
content of policy or programmatic
interest, and may include additional

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programs or respondents beyond those
participating in the Core FACES study.
Previous notices provided the
opportunity for public comment on the
proposed Head Start program
recruitment and center selection process
(FR V.78, pg.75569 12/12/2013; FR
V.79, pg.8461 02/12/2014), the childlevel data collection in fall 2014 and
spring 2015 (FR V. 79, pg. 11445 02/28/
2014; FR V. 79; pg. 27620 5/14/2014),
the program- and classroom-level spring
2015 data collection activities (FR v.79;
pg. 73077 12/09/2014), the American
Indian and Alaska Native Head Start
Family and Child Experiences Survey
(AI/AN FACES) child-level data
collection activities in fall 2015 and
spring 2016 (FR V. 80, pg. 30250 08/07/
2015) and AI/AN FACES program- and
classroom-level spring 2016 data
collection activities (FR V. 80, pg 70231
11/13/2015).
This 30-day notice describes the
planned additional data collection
activities for FACES program- and
classroom-level data collection in spring
2017. Spring 2017 data collection
includes site visits to 360 centers in 180
Head Start programs. As in spring 2015,
for the Core study teachers, program
directors, and center directors will each
complete surveys, approximately 25 to
30 minutes in length. Two Plus studies
are planned related to program
functioning for spring 2017. First,
program and center directors in all 180
programs (and 360 centers) will
complete a 5-minute survey on how
programs are planning for implementing
the new Head Start program
performance standards. Second, all 720
teachers will complete a survey on
program functioning, initially piloted in
spring 2015.
The purpose of the Core data
collection is to support the 2007
reauthorization of the Head Start
program (Pub. L. 110–134), which calls
for periodic assessments of Head Start’s
quality and effectiveness. As additional
information collection activities are
fully developed, in a manner consistent
with the description provided in the 60day notice (79 FR 11445) and prior to
use, we will submit these materials for
a 30-day public comment period under
the Paperwork Reduction Act.
Respondents: Head Start teachers and
Head Start directors.

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