60 day FRN

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Federal Register / Vol. 85, No. 168 / Friday, August 28, 2020 / Notices
The purpose of this study is to
conduct an epidemiologic, mixedmethods evaluation of OUD treatment in
real-world outpatient settings. Client
recruitment for this study was originally
scheduled to take place between 5/1/
2018 and 8/31/2019, however patient
recruitment levels were lower than
originally anticipated. The recruitment
period was extended to 11/30/2019 to
enable to recruit additional patients.
Because the follow-up period for this

such as multilevel latent growth models,
propensity score matching, latent class
analysis and advance mediation
analysis and qualitative methods such
as interactive coding and analysis for
common themes. There are no costs to
respondents other than their time. The
only cost to respondents will be time
spent responding to the survey/screener.
CDC requests approval for 300
annualized burden hours.

study is 18 months, patients recruited
during the extended recruitment period
(8/31/2019 to 11/30/2019) will need to
complete their final 18-Month Patient
Questionnaire between 2/28/2021 and
5/31/2021, which is after the current
OMB expiration date. The extended
time period is only needed for one of
the data collection instruments, thus
there is a reduction in burden of 3839
hours.
The study uses a mixed-method
approach using quantitative methods

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
burden
hours

Type of respondent

Form name

Patients .............................................

Client Questionnaire 18-Month Follow-up.

400

1

45/60

300

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

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

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

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

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

300

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–18997 Filed 8–27–20; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–20QN; Docket No. CDC–2020–
0085]

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 efforts 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 ‘‘Availability, Use, and
Public Health Impact of Emergency
Supply Kits among Disaster-Affected
Populations.’’ The goal of this study is
to determine the efficacy and public
health impact of emergency supply kits
among disaster-affected populations to

SUMMARY:

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understand how emergency supply kits
are used during and after a natural
disaster, if public health outcomes are
associated with access to emergency
supply kits, and what the most useful
items to include in an emergency
supply kit are across different types of
disasters.
DATES: Written comments must be
received on or before October 27, 2020.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2020–
0085 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey Zirger, 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 Jeffry Zirger,
Information Collection Review Office,
Centers for Disease Control and

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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.
The OMB is particularly interested in
comments that will help:
1. 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;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,

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53378

Federal Register / Vol. 85, No. 168 / Friday, August 28, 2020 / Notices

electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
Proposed Project
Availability, Use, and Public Health
Impact of Emergency Supply Kits
Among Disaster-Affected Populations—
New—National Center for
Environmental Health (NCEH), Centers
for Disease Control and Prevention
(CDC)
Background and Brief Description
The National Center for
Environmental Health (NCEH) is
requesting a new information collection
request (ICR) with two years of
approval. An all-of-society approach to
disaster risk reduction emphasizes
inclusion and engagement in
preparedness activities. A common
recommendation is to promote
household preparedness through the
preparation of an emergency supply kit
that can be used to shelter-in-place or
during evacuation. Lack of household
preparedness is a public health concern,
especially in medically frail
populations, because it consumes first
responders’ time, taking them away
from relief and recovery efforts, and can
easily deplete community health
resources. The Federal Emergency
Management Agency (FEMA) states that
individuals or households are prepared
for a disaster if they have thought about
and planned for the types of disaster for
which they are at most risk, have
developed a family communication and
evacuation plan in the event of a
disaster, and have assembled a complete
disaster (emergency) supply kit.
However, the prevalence of emergency
supply kits across households in the
United States ranges considerably from
a community-level low of 10% to a
regional high of 68%. This lack and
variation of emergency supply kits
across households makes household
disaster preparedness a public health
concern.
Self-sufficiency (defined as the ability
to shelter-in-place without needing to

prevents the worsening of conditions or
the need for emergency medical services
• Lack of data to support emergency
supply kit recommendations: It is
unclear whether having essential
supplies improves self-sufficiency and
lessens the need for outside assistance
This general lack of research on the
efficacy and use of emergency supply
kits impedes our ability to make datadriven recommendations regarding
emergency supply kit promotion. The
cross-sectional disaster survey and focus
group(s) on the public’s knowledge,
preparedness, and use of emergency
supply kits will identify and inform
public health officials about the most
useful items to include in an emergency
supply kit, ideally across two different
types of disasters. Data collection is
anticipated to be between September
2020 and April 2022, depending upon
disaster occurrence. Parameters for site
selection include a major or state-level
disaster declaration for a natural
disaster that affects a mid- to highdensity area (e.g., population of 100,000
people) within the United States.
Survey participants will be selected
via address-based sampling in the
defined geographic area impacted by the
disaster and given the choice to
complete the survey via paper (i.e.,
Teleform) or online via a web-based
instrument. Survey participants will
also be recruited using an existing,
nonprobability web panel and be
directed to the online, web-based
instrument to create a larger, more costeffective dataset. Focus group
participants will be randomly selected
among survey respondents and/or
recruited via targeted social media (e.g.,
Facebook, Craigslist) to provide context
and enhancement to the survey.
The estimated annualized burden is
464 hours. The estimated burden is
based on conducting the survey in two
sites, taking 15-minutes per respondent
via the web or 45 minutes via paper
survey, and up to two focus groups in
each site taking approximately 120
minutes. There is no cost to respondents
other than their time.

leave your home or call for outside
assistance for ∼3 days following a
disaster) can help reduce the demands
placed on first responders during
critical times, which has downstream
public health impacts. Among persons
with an existing physical or mental
health condition at the time of the
disaster, having an adequate supply of
prescription and over-the-counter
medications and medical supplies
allows people to maintain treatment and
prevent worsening or exacerbation of
their existing condition or illness. It also
can reduce their need for emergency
medical services following a disaster.
The FEMA definition of an emergency
supply kit is one that can sustain each
member of a household with food,
water, and medication for up to three
days. However, there are several
knowledge gaps and challenges related
to emergency supply kit use and
effectiveness, including whether the
current recommendations are adequate
or need expansion. We identified the
following gaps:
• Lack of consistency for what
supplies to include in an emergency
supply kit: While the public can access
information on what contents are likely
important to include in emergency
supply kits, there is a lack of
information as to whether there is a
standard set of supplies that is
consistently needed across disaster
types
• Lack of a standard tool for
evaluation of emergency supply kit use
and effectiveness
• Lack of information on how
emergency supply kit items are used
during or following disasters: Currently
we lack detailed information on how
households use emergency supply kit
items during or following disasters and
what, if any, are barriers to their use
• Lack of information on effectiveness
of emergency supply kits in preventing
adverse outcomes: To our knowledge,
there is no information on whether the
use of emergency supply items prevents
adverse health outcomes. Among
individuals with health conditions, it
remains unclear whether preparing an
emergency supply kit with adequate
medications and medical supplies

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
annualized
burden
(in hours)

Type of respondent

Form name

General Public Household Member ..

Web Survey ......................................
Paper Survey ...................................
Focus Group ....................................

667
333
24

1
1
1

15/60
45/60
120/60

166
250
48

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

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

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

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

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

464

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Federal Register / Vol. 85, No. 168 / Friday, August 28, 2020 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–18996 Filed 8–27–20; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–0621]

Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled National Youth
Tobacco Survey 2021–2023 to the Office
of Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on January
23, 2020 to obtain comments from the
public and affected agencies. CDC
received six comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(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.

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To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
National Youth Tobacco Survey 2021–
2023 (OMB Control No. 0920–0621, Exp.
4/30/2021)—Revision—National Center
for Chronic Disease Prevention and
Health Promotion (NCCDPHP), Centers
for Disease Control and Prevention
(CDC)
Background and Brief Description
Tobacco use is the leading cause of
preventable disease and death in the
United States, and nearly all tobacco use
begins during youth and young
adulthood. A limited number of health
risk behaviors, including tobacco use,
account for the overwhelming majority
of immediate and long-term sources of
morbidity and mortality. Because many
health risk behaviors are established
during adolescence, there is a critical
need for public health programs
directed towards youth, and for
information to support these programs.
Since 2004, the Centers for Disease
Control and Prevention (CDC) has
periodically collected information about
tobacco use among adolescents
(National Youth Tobacco Survey
(NYTS) 2004, 2006, 2009, 2011, 2012,
2013–2020, OMB Control No. 0920–
0621, Exp. 04/30/2021). This
surveillance activity builds on previous
surveys funded by the American Legacy
Foundation in 1999, 2000, and 2002.
At present, the NYTS is the most
comprehensive source of nationally
representative tobacco data among
students in grades 9–12. Moreover, the
NYTS is the only source of such data for
students in grades 6–8. The NYTS has
provided national estimates of tobacco
use behaviors, information about

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exposure to pro- and anti-tobacco
influences, and information about racial
and ethnic disparities in tobacco-related
topics. Information collected through
the NYTS is used to identify trends over
time, to inform the development of
tobacco cessation programs for youth,
and to evaluate the effectiveness of
existing interventions and programs.
CDC plans to request OMB approval
to conduct additional cycles of the
NYTS in 2021, 2022, and 2023. The
survey will be conducted among
nationally representative samples of
students attending public and private
schools in grades 6–12 and will be
administered to students as a digitallybased survey programmed onto tablets.
Information supporting the NYTS also
will be collected from state-, district-,
and school-level administrators and
teachers. During the 2021–2023
timeframe, changes will be incorporated
that reflect CDC’s ongoing collaboration
with FDA and the need to measure
progress toward meeting strategic goals
established by the Family Smoking
Prevention and Tobacco Control Act.
Information collection will occur
annually and may include a number of
new questions, as well as increased
representation of minority youth.
The survey will examine the
following topics: Use of e-cigarettes,
cigarettes, cigars, smokeless tobacco,
hookahs, roll-your own-cigarettes,
pipes, snus, dissolvable tobacco, bidis,
heated tobacco products, and nicotine
pouches; knowledge and attitudes;
media and advertising; access to tobacco
products and enforcement of restrictions
on access; secondhand smoke and ecigarette aerosol exposure; provision of
school- and community-based
interventions, and cessation.
Results of the NYTS will continue to
be used to inform and evaluate the
National Comprehensive Tobacco
Control Program; provide data to inform
the Department of Health and Human
Service’s Tobacco Control Strategic
Action Plan, and provide national
benchmark data for state-level Youth
Tobacco Surveys. Information collected
through the NYTS also is expected to
provide multiple measures and data for
monitoring progress on seven tobaccorelated objectives for Healthy People
2030.
OMB approval will be requested for
three years. There are no costs to
respondents other than their time. The
total annualized burden is estimated to
be 18,733 hours.

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