60 day FRN

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Federal Register / Vol. 85, No. 191 / Thursday, October 1, 2020 / Notices
styrene has also been associated with
cases of non-malignant respiratory
disease (NMRD), including COPD and
obliterative bronchiolitis. However,
little is understood about the long-term
respiratory effects on styrene-exposed
workers.
The goal of this project is to
understand the prevalence of long-term
respiratory morbidity in styreneexposed workers. The objectives of the
proposed study are: (1) To characterize
work exposures by acquiring job
histories and comparing with historical
exposure levels obtained from a past
industrial hygiene survey, (2) to
examine prevalence of respiratory
morbidity by duration and level of
styrene exposure and other
characteristics, (3) to apply research
biomarkers of lung injury to a styreneexposed workforce, and (4) to describe
the prevalence of color vision

impairment with the presence of
respiratory morbidity. Our hypothesis is
that workers previously exposed to high
concentrations of styrene (≥5 ppm),
even those with short tenure (<1 year),
will have a higher prevalence of
respiratory symptoms and lung function
abnormalities compared with workers
exposed to low concentration of styrene
(<5ppm).
We will conduct face-to-face
interviews with members of a cohort of
workers from two reinforced plastic
boatbuilding plants that closed in 1989
and 1993. The purpose of the interviews
is to collect demographic information,
detailed job history during and after the
worker’s tenure at the boatbuilding
plant, upper and lower respiratory
symptoms, physician diagnoses of
respiratory diseases, cigarette smoking
history, and medication use. A NIOSH
employee will conduct the interviews.

We will also conduct several lung
function tests including: Exhaled nitric
oxide, impulse oscillometry, multiplebreath washout, spirometry, and
bronchodilator reversibility testing.
The purpose of the lung function
testing is to identify small and large
airway abnormalities that are consistent
with NMRD. NIOSH technicians will
perform the lung function testing. We
will collect blood to analyze for
biomarkers associated with lung injury
caused by obliterative bronchiolitis. A
NIOSH phlebotomist will collect the
blood samples. Finally, we will assess
cohort members for color vision
abnormalities using the Lanthony D–15
Color Test. Color vision assessment will
be completed by a NIOSH technician.
The only cost to boatbuilder cohort
members is local travel to the medical
survey site and their time. The total
estimated burden hours are 712.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Boatbuilder Cohort Members ..........................

Questionnaire and medical survey consent
form.
Questionnaire .................................................
Exhaled Nitric Oxide—no form ......................
Impulse Oscillometry—no form ......................
Spirometry—no form ......................................
Bronchodilator Test—no form ........................
Multiple-Breath Washout—no form ................
Color vision test—no form .............................
Blood test—no form .......................................

Boatbuilder
Boatbuilder
Boatbuilder
Boatbuilder
Boatbuilder
Boatbuilder
Boatbuilder
Boatbuilder

Cohort
Cohort
Cohort
Cohort
Cohort
Cohort
Cohort
Cohort

Members
Members
Members
Members
Members
Members
Members
Members

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–21735 Filed 9–30–20; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-20–1278; Docket No. CDC–2020–
0101]

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:
jbell on DSKJLSW7X2PROD with NOTICES

Number of
respondents

Type of respondents

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public

SUMMARY:

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22:13 Sep 30, 2020

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burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled ‘‘Online training for law
enforcement to reduce risks associated
with shift work and long work hours.’’
This study will develop and pilot test a
new, online, interactive training
program tailored for the law
enforcement community that relays the
health and safety risks associated with
shift work, long work hours, and related
workplace sleep issues, and presents
strategies for managers and officers to
reduce these risks.
CDC must receive written
comments on or before November 30,
2020.

DATES:

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Sfmt 4703

Number of
responses per
respondent

Average
burden per
response
(in hours)

676

1

15/60

676
676
676
676
50
676
676
676

1
1
1
1
1
1
1
1

45/60
5/60
10/60
10/60
20/60
30/60
5/60
5/60

You may submit comments,
identified by Docket No. CDC–2020–
0101 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. 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. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
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 Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
ADDRESSES:

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Federal Register / Vol. 85, No. 191 / Thursday, October 1, 2020 / Notices

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 the 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,
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.

jbell on DSKJLSW7X2PROD with NOTICES

Proposed Project
Online training for law enforcement
to reduce risks associated with shift
work and long work hours (OMB
Control No. 0920–1278, Exp. 12/30/
2020)—Extension—National Institute
for Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Police often work during the evening,
at night, and sometimes irregular and
long hours. Shift work and long work
hours are linked to many health and
safety risks due to disturbances to sleep
and circadian rhythms. These work
schedules also lead to difficulties with
personal relationships due to having

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22:13 Sep 30, 2020

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less time with family and friends, poor
mood from sleep deprivation, and
problems balancing work and personal
responsibilities. These work schedules
and inadequate sleep likely contribute
to health problems seen in police:
shorter life spans, high occupational
injury rates, and burden of chronic
illnesses. One strategy to reduce these
risks is training programs to inform
employers and law enforcement officers
about the risks and strategies to reduce
their risks.
An extension is being requested due
to delays recruiting participants and
initiating data collection activities. The
delays resulted from the COVID–19
pandemic and the civil unrest after
George Floyd’s death on May 25, 2020.
Law enforcement leaders requested that
the data collection be delayed until the
end of June 2020. As a result, NIOSH is
requesting a one-year extension for an
extension of the data collection end date
to May 31, 2021. This pilot study is part
of a project awarded National
Occupational Research Agenda (NORA)
funding. The National Institute for
Occupational Safety and Health is
authorized to carry out this data
collection through Occupational Safety
and Health Act of 1970.
The purpose of this project is to
develop a training program to relay the
risks linked to shift work and long work
hours and give workplace strategies for
employers and personal strategies for
the officers to reduce the risks. Once
finalized, the training will be available
on the NIOSH website. The training will
be pilot tested with 30 recent graduates
of a police academy and 30 experienced
officers. The study will recruit 60 law
enforcement officers during a 30-minute
phone call. All respondents will work
full-time on fixed night shifts. The pilot
test will use a pre-test—post-test design
to examine sleep (both duration and
quality), worktime sleepiness, and
knowledge retained. Pre-test measures
will be collected two weeks before the
training. Post-test measures will be
collected the week of the training (week
three of the study), one week after the
training (week four) and at eight and
nine weeks after the training (weeks 11
and 12 of the study). Additional posttest measures will include feedback
about the training and if specific
behaviors changed.
Before starting the pretest, the
respondent will sign an informed
consent form. The pilot pre-test will
start with the respondent filling out a
10-minute online survey that includes
four short surveys: (1) Demographic
information and work experience; (2)
the Epworth Sleepiness Scale; (3) the

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Pittsburgh Sleep Quality Index; and (4)
a knowledge test. The respondent will
be fitted with a wrist actigraph, which
will record activity and estimate the
times of sleep. The respondents will
keep an online sleep activity diary and
wear the actigraph continuously during
weeks one to four of the study. The
online sleep activity diary takes
approximately two minutes a day to
complete. The sleep diary and actigraph
are being used together to obtain a more
accurate timing of respondent’s sleep
and activity.
During the third week of the study,
the respondent will take the 2.5 hour
online training program. Immediately
after completing the training, the
respondent will take the post-test
knowledge test and will provide
feedback about the training including
barriers to using the training
information and what influential people
in their life would want them to do with
the training information. At the end of
week four, the respondent will return
the actigraph. No data collection will
occur during weeks five to 10 of the
study.
The second post-test period will be
weeks 11 and 12 of the study to gather
longer-term outcomes. At the beginning
of week 11, the respondents will be
fitted with an actigraph. The respondent
will wear the actigraph and complete
the sleep activity diary for the next 14
days. At the end of week 12 of the
study, the respondent will complete the
Epworth Sleepiness Scale, Pittsburgh
Sleep Quality Index, and Changes in
Behaviors After Training. The combined
response time is five minutes.
The burden table lists three 10-minute
meetings during the post-test period
when they will return the actigraph at
the end of week four, be fitted with an
actigraph at the beginning of week 11
and return it at the end of week 12. The
respondents will complete the sleep
activity diary for 42 days total (two
minutes each day). The total burden
hours for the diary is 84.
Study staff will use the findings from
the pilot test to make improvements to
the training program. The research team
will reinforce or expand training
content that showed less than desired
results on the pilot test. Potential
impacts of this project include
improvements in management practices
such as the design of work schedules
and improvements in officers’ personal
behaviors for coping with the demands
of shift work and long work hours. The
total estimated annualized burden hours
is 334. There are no costs to respondents
other than their time.

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61953

Federal Register / Vol. 85, No. 191 / Thursday, October 1, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Total burden
(in hours)

Form name

Law enforcement officers ..................

60

1

30/60

30

60
60
60
60
60
60
60
60

1
2
2
2
1
42
1
1

15/60
5/60
1/60
2/60
2/60
2/60
150/60
5/60

15
10
2
4
2
84
150
5

Law enforcement officers ..................
Law enforcement officers ..................

phone call for recruitment & informed consent.
Initial meeting ...................................
Knowledge survey ............................
Epworth Sleepiness Scale ...............
Pittsburgh Sleep Quality Index ........
Demographics and work experience
Sleep diary .......................................
Online training ..................................
Feedback about Training, Barriers,
and Influential People.
Changes in Behaviors after Training
Actigraph fitting and return ...............

60
60

1
3

2/60
10/60

2
30

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

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

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

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

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

334

Law
Law
Law
Law
Law
Law
Law
Law

enforcement
enforcement
enforcement
enforcement
enforcement
enforcement
enforcement
enforcement

officers
officers
officers
officers
officers
officers
officers
officers

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–21731 Filed 9–30–20; 8:45 am]
BILLING CODE 4163–18–P

and corrected in this correcting
document. The provision in this
correction document is effective as if it
had been included in the document
published September 28, 2020.
Accordingly, the correction is effective
September 28, 2020.
II. Summary of Error

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3386–CN]

Medicare Program; Approval of
Application by The Compliance Team
for Initial CMS-Approval of its Home
Infusion Therapy Accreditation
Program; Correction
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice; correction.
AGENCY:

This document corrects a
technical error that appeared in the final
notice published in the Federal Register
on September 28, 2020 entitled
‘‘Medicare Program; Approval of
Application by The Compliance Team
for Initial CMS-Approval of Its Home
Infusion Therapy Accreditation
Program.’’

SUMMARY:

On page 60799, in the DATES section
of the notice, the phrase ‘‘takes effect
October 1, 2020 through October 1,
2024’’ should be replaced with the
phrase ‘‘September 28, 2020-September
28, 2024.’’

The Use of Physiologically Based
Pharmacokinetic Analyses—
Biopharmaceutics Applications for
Oral Drug Product Development,
Manufacturing Changes, and Controls;
Draft Guidance for Industry;
Availability
AGENCY:

Food and Drug Administration,

HHS.
SUMMARY:

Dated: September 28, 2020.
Wilma M. Robinson,
Deputy Executive Secretary to the
Department, Department of Health and
Human Services.
[FR Doc. 2020–21766 Filed 9–28–20; 4:15 pm]
BILLING CODE 4120–01–P

Christina Mister-Ward, (410) 786–2441.
Shannon Freeland, (410) 786–4348.
Lillian Williams, (410) 786–8636.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. 2020–21260 of September
28, 2020 (85 FR 60799–60800), there
was a technical error that is identified

Jkt 253001

[Docket No. FDA–2020–D–1517]

In the Federal Register of September
28, 2020, in FR Doc. 2020–21260, on
page 60799, in the 2nd column, in the
DATES section, the phrase ‘‘takes effect
October 1, 2020 through October 1,
2024’’ is corrected to read ‘‘September
28, 2020-September 28, 2024.’’

FOR FURTHER INFORMATION CONTACT:

22:13 Sep 30, 2020

Food and Drug Administration

ACTION:

This correction is effective
September 28, 2020.

VerDate Sep<11>2014

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

III. Correction of Error

DATES:

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burden per
response
(in hours)

Number of
responses per
respondent

Type of respondents

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Notice of availability.

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘The Use
of Physiologically Based
Pharmacokinetic Analyses—
Biopharmaceutics Applications for Oral
Drug Product Development,
Manufacturing Changes, and Controls.’’
This guidance provides general
recommendations regarding the
development, evaluation, and use of
physiologically based pharmacokinetic
(PBPK) analyses for biopharmaceutics
applications employed by sponsors of
investigational new drug applications,
new drug applications, or abbreviated
new drug applications, and
supplements to these applications, for
oral drug product development,
manufacturing changes, and controls.
The guidance covers how to develop,
evaluate, and apply PBPK models for
biopharmaceutics-related uses, such as
establishing clinically relevant
dissolution specifications and quality
risk assessment for postapproval
manufacturing changes.

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