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Emergency Epidemic Investigation Data Collections

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Federal Register / Vol. 87, No. 175 / Monday, September 12, 2022 / Notices

at the participating carriers. A
convenience sample of 180 eligible
drivers who have a valid Class-A
commercial driver’s license (CDL) and
work at the participating company in
regional and long-haul operations for at
least one year will be eligible for the
study. The study sample will include
approximately 90 regional and 90 longhaul drivers. There will be no required
minimum number of female or minority
drivers to be included.
Data will be collected during each
phase: (1) In the application, drivers
will be asked to provide their name and
contact information (home address,
telephone number, and email address)
to allow contact from the research team
regarding their eligibility for the study;
(2) In the briefing session, drivers will
be asked to complete the Background
Questionnaire; and (3) During the study,
information collection will occur

week) and middle (second month) of the
baseline phase, and the middle (fifth
month) and end (eighth month) of the
intervention phase); (f) a questionnaire
to assess corporate practices and
corporate safety climate will be given to
managers at the participating carriers
(these will be completed by managers at
the beginning (first week) of the study
and end (eighth month) of the
intervention phase); and (g) during the
field study, carriers will be asked to
provide information concerning crashes
and roadside violations occurring
during each driver’s period of study
participation. Administrative cost
information (e.g., equipment, labor, etc.)
will also be collected from the carrier to
evaluate cost-benefit of the intervention.
CDC requests OMB approval for an
estimated 5,278 annual burden hours.
There is no cost to respondents other
than their time to participate.

through several streams: (a) real-time
fatigue monitoring system installed in
the participating driver’s vehicle; (b)
smart phone apps to collect
psychomotor vigilance test, Karolinska
Sleepiness Scale, sleep log, difficulty of
drive scale, degree of drive hazards
scale, a fatigue scale, and a stress scale;
(c) an electronic logging device to
collect data on the driver’s duty and
driving; (d) a wrist actigraphy to collect
data on driver sleep and wake times.
Drivers will be asked to sync the
actigraph with a smartphone app daily;
(e) smartphone or web-based
questionnaires including Exercise and
Food Consumption Questionnaire, the
Quality of Life short form 36 version-2
questionnaire (SF–36v2), Family
Interactions Questionnaire, and Job
Descriptive Index (these will be
completed by drivers at four different
intervals, including the beginning (first

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Carrier Management .........................

Participation Agreement ...................
Retrieval of Company Monthly
Roadside Violations/Crash Reports.
Retrieval of Company Administrative
Costs.
Management Practice questionnaire
(Time 1).
Management Practice questionnaire
(Time 2).
Application to Participate .................
Actigraph Training ............................
Background Questionnaire ...............
Daily Smartphone Questions ...........
PVT ..................................................
Exercise and Food Consumption
Questionnaire.
SF–36v2 ...........................................
Family Interactions Questionnaire ...
Safety Climate Questionnaire ..........
Job Descriptive Index .......................
Post-Study Questionnaire ................
Phone Briefings ................................

Drivers ...............................................

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

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–19558 Filed 9–9–22; 8:45 am]

Number of
responses per
respondent

Number of
respondents

Type of respondent

1
8

1
90/60

1
12

1

16

2

32

5

1

45/60

4

5

1

45/60

4

150
90
90
90
90
90

1
1
1
720
720
4

12/60
10/60
45/60
1/60
3/60
20/60

30
15
68
1,080
3,240
120

90
90
90
90
90
90

4
4
4
4
1
8

30/60
15/60
10/60
30/60
1
6/60

180
90
60
180
90
72

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

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

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

5,278

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

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Agency Forms Undergoing Paperwork
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In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)

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Total burden
(in hours)

1
1

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has submitted the information
collection request titled ‘‘Emergency
Epidemic Investigations’’ 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 April 18,
2022 to obtain comments from the
public and affected agencies. CDC did
not receive comments related to the
previous notice. This notice serves to

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Federal Register / Vol. 87, No. 175 / Monday, September 12, 2022 / Notices
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.
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
Emergency Epidemic Investigation
(OMB Control No. 0920–1011, Exp. 1/
31/2023)—Extension—Center for
Surveillance, Epidemiology and
Laboratory Services (CSELS), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC previously conducted Emergency
Epidemic Investigations (EEIs) under
Office of Management and Budget
(OMB) Control No. 0920–0008. In 2013,
CDC received OMB approval (OMB
Control No. 0920–1011) for a new OMB
generic clearance to collect vital
information during EEIs in response to
outbreaks or other urgent public health
events (i.e., natural, biological,
chemical, nuclear, radiological)
characterized by undetermined agents,
undetermined sources, undetermined
transmission, or undetermined risk
factors. This Generic clearance was most
recently approved for a three-year
Extension, which expires on 1/31/2023.
CDC seeks OMB approval for an
Extension of this Generic clearance for
an additional three-year period.
Supporting effective EEIs is one of the
most important ways that CDC protects
the health of the public. CDC is
frequently called upon to conduct EEIs
at the request of local, state, or
international health authorities seeking
support to respond to outbreaks or
urgent public health events. In response
to external partner requests, CDC
provides necessary epidemiologic
support to identify the agents, sources,
modes of transmission, or risk factors to
effectively implement rapid prevention
and control measures to protect the
public’s health. Data collection is a
critical component of the epidemiologic
support provided by CDC; data are
analyzed to determine the agents,
sources, modes of transmission, or risk
factors so that effective prevention and
control measures can be implemented.
During an unanticipated outbreak or
urgent public health event, immediate

action by CDC is necessary to minimize
or prevent public harm.
The legal justification for EEIs are
found in the Public Health Service Act
(42 U.S.C. Sec. 301 [241] (a). Successful
investigations are dependent on rapid
and flexible data collection that evolves
during the investigation and is
customized to the unique circumstances
of each outbreak or urgent public health
event. Data collection elements will be
those necessary to identify the agents,
sources, mode of transmission, or risk
factors. Examples of potential data
collection methods include telephone or
face-to-face interview; email, web, or
other type of electronic questionnaire;
paper-and-pencil questionnaire; focus
groups; medical record review and
abstraction; laboratory record review
and abstraction; collection of clinical
samples; and environmental assessment.
Respondents will vary depending on the
nature of the outbreak or urgent public
health event; examples of potential
respondents include health care
professionals, patients, laboratorians,
and the general public. Participation in
EEIs is voluntary and there are no
anticipated costs to respondents other
than their time. CDC will use the
information gathered during EEIs to
rapidly identify and effectively
implement measures to minimize or
prevent public harm.
CDC projects 60 EEIs in response to
outbreaks or urgent public health events
characterized by undetermined agents,
undetermined sources, undetermined
transmission, or undetermined risk
factors annually. The projected average
number of respondents is 200 per EEI,
for a total of 12,000 respondents. CDC
estimates the average burden per
response is 0.5 hours per respondent,
and each respondent will be asked to
respond once. CDC requests OMB
approval for a total of 6,000 estimated
annual burden hours. OMB approval is
requested for three years, and there is no
cost to respondents other than their
time.

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondents

Form name

Emergency Epidemic Investigation Participants.

Emergency Epidemic Investigation Data Collection Instruments.

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12,000

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Number of
responses per
respondent
1

Average
burden per
response
(in hours)
30/60

55812

Federal Register / Vol. 87, No. 175 / Monday, September 12, 2022 / Notices

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–19559 Filed 9–9–22; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Clinical Laboratory Improvement
Advisory Committee
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:

In accordance with the
Federal Advisory Committee Act, the
CDC announces the following meeting
for the Clinical Laboratory Improvement
Advisory Committee (CLIAC). This
meeting is open to the public, limited
only by the number of webcast lines
available. Time will be available for
public comment.
DATES: The meeting will be held on
November 9, 2022, from 11:00 a.m. to
6:00 p.m., EST, and November 10, 2022,
from 11:00 a.m. to 6:00 p.m., EST.
ADDRESSES: This is a virtual meeting.
Meeting times are tentative and subject
to change. The confirmed meeting
times, agenda items, and meeting
materials, including instructions for
accessing the live meeting broadcast,
will be available on the CLIAC website
at https://www.cdc.gov/cliac. Check the
website on the day of the meeting for
the web conference link.
FOR FURTHER INFORMATION CONTACT:
Heather Stang, MS, Deputy Chief,
Quality and Safety Systems Branch,
Division of Laboratory Systems, Center
for Surveillance, Epidemiology, and
Laboratory Services, Deputy Director for
Public Health Science and Surveillance,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE,
Mailstop V24–3, Atlanta, Georgia
30329–4027; Telephone: (404) 498–
2769; Email: [email protected].
SUPPLEMENTARY INFORMATION:
Purpose: This Committee is charged
with providing scientific and technical
advice and guidance to the Secretary,
HHS; the Assistant Secretary for Health;
the Director, CDC; the Commissioner,
Food and Drug Administration (FDA);
and the Administrator, Centers for
Medicare & Medicaid Services (CMS).
The advice and guidance pertain to
general issues related to improvement in
clinical laboratory quality and

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SUMMARY:

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laboratory medicine and specific
questions related to possible revision of
the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) standards.
Examples include providing guidance
on studies designed to improve quality,
safety, effectiveness, efficiency,
timeliness, equity, and patientcenteredness of laboratory services;
revisions to the standards under which
clinical laboratories are regulated; the
impact of proposed revisions to the
standards on medical and laboratory
practice; and the modification of the
standards and provision of nonregulatory guidelines to accommodate
technological advances, such as new
test methods, the electronic
transmission of laboratory information,
and mechanisms to improve the
integration of public health and clinical
laboratory practices.
Matters To Be Considered: The agenda
will include agency updates from CDC,
CMS, and FDA. Presentations and
CLIAC discussions will focus on the
clinical and public health response to
the monkeypox outbreak, efforts to
address public health and clinical
laboratory workforce challenges, and
reports from two CLIAC workgroups:
the CLIA Regulations Assessment
Workgroup and the CLIA Certificate of
Waiver and Provider-performed
Microscopy Procedures Workgroup.
Agenda items are subject to change as
priorities dictate.
Public Participation
It is the policy of CLIAC to accept
written public comments and provide a
brief period for oral public comments
pertinent to agenda items.
Oral Public Comment: Public
comment periods for each agenda item
are scheduled immediately prior to the
Committee discussion period for that
item. In general, each individual or
group requesting to present an oral
comment will be limited to a total time
of five minutes (unless otherwise
indicated). Speakers should email
[email protected] or notify the contact
person above (see FOR FURTHER
INFORMATION CONTACT) at least five
business days prior to the meeting date.
Written Public Comment: CLIAC
accepts written comments until the date
of the meeting (unless otherwise stated).
However, it is requested that comments
be submitted at least five business days
prior to the meeting date so that the
comments may be made available to the
Committee for their consideration and
public distribution. Written comments
should be submitted by email to
[email protected] or to the contact person
above. All written comments will be

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included in the meeting minutes posted
on the CLIAC website.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2022–19569 Filed 9–9–22; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–22–0573]

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 HIV
Surveillance System (NHSS)’’ 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 April 1, 2022, to obtain
comments from the public and affected
agencies. CDC received two comments
related to the previous notice. No
changes were made to the information
collection plan. 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;

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