Submission for OMB Review; Screening Tool for Unaccompanied Alien Children Program Staff and Visitors (New Collection), 53381-53382 [2020-19024]
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53381
Federal Register / Vol. 85, No. 168 / Friday, August 28, 2020 / Notices
will be enrolled in the study. Drivers
will have a debriefing session if a driver
chooses to withdraw from the study
early or upon completion of the 8month participation period.
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. A convenience sample of 180
eligible drivers will be recruited to
participate in the study. The study
sample will include approximately 90
regional and 90 long-haul drivers. There
will be no required minimum number of
female or minority drivers.
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. (3) During the study,
information collection will occur
through several streams: (a) A real-time
fatigue monitoring system installed in
the participating driver’s vehicle; (b)
Smart phone apps to collect data from
a psychomotor vigilance test, the
Karolinska Sleepiness Scale, a sleep log,
a difficulty of drive scale, a degree of
drive hazards scale, a fatigue scale, and
a stress scale; (c) an electronic logging
device which will record information
about the driver’s hours of service and
driving; (d) a wrist actigraphy device to
collect data on driver sleep and wake
times. Drivers will be asked to
synchronize the actigraph with a
smartphone app daily; (e) smartphone
or web-based questionnaires including
an 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 (1st week) and
middle (2nd month) of the baseline
phase, and the middle (5th month) and
end (8th 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
(1st week) of the study and end (8th
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.
OMB approval is requested for two
years. Participation is voluntary and
there are no costs to respondents other
than their time. The total estimated
annualized burden is 5,278 hours.
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 .............................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–18994 Filed 8–27–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Screening Tool for Unaccompanied
Alien Children Program Staff and
Visitors (New Collection)
Office of Refugee Resettlement,
Administration for Children and
Families, Health and Human Services
(HHS).
ACTION: Request for public comment.
AGENCY:
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Number of
responses per
respondent
Number of
respondents
Type of respondent
Average
burden per
response
(in hours)
1
1
1
8
1
90/60
1
5
5
150
90
90
90
90
90
16
1
1
1
1
1
720
720
4
2
45/60
45/60
12/60
10/60
45/60
1/60
3/60
20/60
90
90
90
90
90
90
4
4
4
4
1
8
30/60
15/60
10/60
30/60
1
6/60
The Office of Refugee
Resettlement (ORR), Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), is proposing to continue
use of a coronavirus (COVID–19)
screening form for Unaccompanied
Alien Children (UAC) program staff and
visitors at ORR-funded programs. The
form was originally approved under
emergency approval for 6 months. ACF
is requesting a 3-year extension of this
information collection.
DATES: Comments due within 30 days of
publication. OMB is required to make a
decision concerning the collection of
SUMMARY:
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53382
Federal Register / Vol. 85, No. 168 / Friday, August 28, 2020 / Notices
information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
ADDRESSES:
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.
SUPPLEMENTARY INFORMATION:
Description: The COVID–19 risk
questionnaire asks participants whether
or not they display COVID–19
symptoms, whether or not they have
had close contact with individuals
known to test positive for COVID–19,
and whether or not they have been
tested for COVID–19. The questionnaire
also requests temperature checks on
individuals. This will help to reduce
possible exposure to the virus and help
protect the health and safety of both
UAC and program staff.
Respondents: Staff and visitors at
UAC program sites.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
UAC COVID–19 Risk Questionnaire ...............................................................
Authority: 6 U.S.C. 279(b)(1)(B);(E).
Emily Ball Jabbour,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–19024 Filed 8–27–20; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0008]
Patient Engagement Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing a
forthcoming public advisory committee
meeting of the Patient Engagement
Advisory Committee. The general
function of the committee is to provide
advice to the Commissioner, or
designee, on complex issues relating to
medical devices, the regulation of
devices, and their use by patients. The
meeting will be open to the public.
DATES: The meeting will take place
virtually on October 22, 2020, from 10
a.m. Eastern Time to 5 p.m. Eastern
Time.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Information on how to access the
webcast will be made available no later
SUMMARY:
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than 2 business days prior to the
meeting at www.fdalive.com/PEAC.
FOR FURTHER INFORMATION CONTACT:
Letise Williams, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave. Bldg. 66, Rm. 5441, Silver Spring,
MD 20993–0002, letise.williams@
fda.hhs.gov, 301–796–8398, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/advisory-committees and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On October
22, 2020, the committee will discuss
and make recommendations on the
topic ‘‘Artificial Intelligence (AI) and
Machine Learning (ML) in Medical
Devices.’’ Specifically, we will discuss
the composition of the datasets on
which the software ‘‘learns’’,
components of the device information
shared with patients, and factors that
impact patient trust in the technology.
Large clinical datasets are used to train
and improve AI/ML algorithms,
allowing transformational
improvements in the diagnosis, clinical
decision making, and treatment of
patients. Devices using AI/ML
technology will transform healthcare
delivery by increasing efficiency of key
processes in the treatment of patients.
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Annual
responses per
respondent
260
Average
burden hours
per response
.033
Annual burden
hours
128,700
Health products powered by AI/ML are
streaming into our lives, from virtual
doctor apps to wearable sensors and
drugstore chatbots to algorithms for
detecting cancer in mammography and
interpretations of chest X rays. Despite
the rapid advancement and integration,
AI/ML systems may have algorithmic
biases, limited generalizability, and lack
transparency in their assumptions based
on potential limitations of training
datasets. The recommendations
provided by the committee will address
the importance of including various
demographic groups in AI/ML algorithm
development. The recommendations
will also address the impact of the user
interface and transparency including
what information and how the
information about the devices could be
communicated to foster patient trust in
the AI/ML devices.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting, and the background
material will be posted on FDA’s
website after the meeting. Background
materials will be available at https://
www.fda.gov/advisory-committees/
committees-and-meeting-materials/
patient-engagement-advisorycommittee. Select the link for the 2020
Meeting Materials. The meeting will
include slide presentations with audio
components to allow the presentation of
materials in a manner that most closely
resembles an in-person advisory
committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Oral presentations
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]]>Agencies
[Federal Register Volume 85, Number 168 (Friday, August 28, 2020)]
[Notices]
[Pages 53381-53382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19024]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Screening Tool for Unaccompanied Alien
Children Program Staff and Visitors (New Collection)
AGENCY: Office of Refugee Resettlement, Administration for Children and
Families, Health and Human Services (HHS).
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Office of Refugee Resettlement (ORR), Administration for
Children and Families (ACF), U.S. Department of Health and Human
Services (HHS), is proposing to continue use of a coronavirus (COVID-
19) screening form for Unaccompanied Alien Children (UAC) program staff
and visitors at ORR-funded programs. The form was originally approved
under emergency approval for 6 months. ACF is requesting a 3-year
extension of this information collection.
DATES: Comments due within 30 days of publication. OMB is required to
make a decision concerning the collection of
[[Page 53382]]
information between 30 and 60 days after publication of this document
in the Federal Register. Therefore, a comment is best assured of having
its full effect if OMB receives it within 30 days of publication.
ADDRESSES: Written 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.
SUPPLEMENTARY INFORMATION:
Description: The COVID-19 risk questionnaire asks participants
whether or not they display COVID-19 symptoms, whether or not they have
had close contact with individuals known to test positive for COVID-19,
and whether or not they have been tested for COVID-19. The
questionnaire also requests temperature checks on individuals. This
will help to reduce possible exposure to the virus and help protect the
health and safety of both UAC and program staff.
Respondents: Staff and visitors at UAC program sites.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total number Annual Average
Instrument of responses per burden hours Annual burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
UAC COVID-19 Risk Questionnaire................. 15,000 260 .033 128,700
----------------------------------------------------------------------------------------------------------------
Authority: 6 U.S.C. 279(b)(1)(B);(E).
Emily Ball Jabbour,
ACF/OPRE Certifying Officer.
[FR Doc. 2020-19024 Filed 8-27-20; 8:45 am]
BILLING CODE 4184-45-P
