Agency Forms Undergoing Paperwork Reduction Act Review, 35866-35868 [2019-15818]
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35866
Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Overdose Data to Action funded jurisdictions
(State—territories—
counties and cities) and their designated delegates.
Evaluation and Performance Measuring Plan Template—Initial Population.
22
1
12
264
Evaluation and Performance Measuring Plan Template—Annual reporting.
Overdose Prevention Capacity Assessment Tool.
Activity Progress Report and Work
Plan Tool—Initial Population.
Activity Progress Report and Work
Plan Tool—Annual Reporting.
Surveillance Data Dissemination
Plan.
66
1
4
264
66
1
1
66
22
1
20
440
66
1
4
264
22
1
1
22
........................
........................
........................
1,320
Total ...........................................
...........................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–15819 Filed 7–24–19; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–19–1125]
Agency Forms Undergoing Paperwork
Reduction Act Review
jspears on DSK30JT082PROD with NOTICES
Number of
respondents
Type of respondents
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Ingress/egress
and work boot outsole wear
investigation at surface mines’’ 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 March 20, 2019 to obtain
comments from the public and affected
agencies. CDC received one comment
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
VerDate Sep<11>2014
17:51 Jul 24, 2019
Jkt 247001
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 or
send an email to omb@cdc.gov. 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
Ingress/egress and work boot outsole
wear investigation at surface mines—
Extension—National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
PO 00000
Frm 00018
Fmt 4703
Sfmt 4703
Background and Brief Description
The mission of the National Institute
for Occupational Safety and Health
(NIOSH) is to promote safety & health at
work for all people through research
and prevention. NIOSH, under Public
Law 91–173 as amended by Public Law
95–164 (Federal Mine Safety and Health
Act of 1977) has the responsibility to
conduct research to improve working
conditions and to prevent accidents and
occupational diseases in the U.S.
mining sector. The goal of the proposed
project is to investigate how ingress/
egress systems on mobile equipment,
and personal protective footwear (boots)
used by miners may lead to slips, trips
and falls at stone, sand and gravel
surface mining facilities. NIOSH is
requesting a two-year extension for this
data collection.
The project objective will be achieved
through two studies. The first study
aims to: identify elements of ingress/
egress systems on haulage trucks and
front end loaders that pose a risk of
slips, trips, and falls (STFs) and could
lead to STF related injuries; to
determine worker behavior associated
with STF incidents; and to learn how
purchasing/maintenance decisions are
made for ingress/egress systems. In the
surface mining industry, it is still
unclear which component of the
ingress/egress system poses the greatest
risk for STF. Hence, there is a need to
understand where, how, and why STF
incidents occur during ingress/egress on
mobile equipment.
NIOSH will conduct semi-structured
interviews and focus groups with
mobile equipment operators, and
interviews will be conducted with mine
management to explore the issues
E:\FR\FM\25JYN1.SGM
25JYN1
35867
Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Notices
identified above. Focus groups will be
conducted in a private setting with 4–
6 participants using a predefined list of
questions to help guide the discussion.
Semi-structured interviews will be
conducted either in person or over the
telephone. Two separate interview
guides will be used for mobile
equipment operators and mine
management to guide the discussion.
For the focus groups and semistructured interviews, NIOSH will
collect basic demographic information
including years of mining experience,
years of experience with haul trucks/
front end loaders, and models of haul
trucks/front end loaders operated most
often in the past year. The semistructured interviews and focus groups
will be audio recorded for further
analysis of the discussion. The semistructured interviews will last no longer
than 60 minutes and the focus groups
will last no longer than 90 minutes.
The second study aims to identify
changes in tread (wear) on the work
boot outsoles and other outsole
characteristics of the boot outsole that
will be used to develop guidelines for
work boot replacement based on
measureable features of boot outsoles.
This information will also be used in
further analysis to determine desirable
and undesirable features of work boots
based on mine characteristics or job
activities. Most mining companies
replace footwear at a pre-determined
interval or based on appearance and
comfort with little knowledge on the
actual condition of the boot outsole and
its influence on the likelihood of a STF
incident. Although there have been
attempts to quantify shoe outsole wear
in industrial work when the shoe was
ready for disposal, there is a lack of
knowledge in the mining industry on
how quickly the outsoles of work boots
wear, what sorts of wear occurs, and
how wear patterns influence the
likelihood of a STF. This study aims to
address this concern through two parts:
A longitudinal study of boot outsole
wear characteristics and a crosssectional evaluation of boot outsole
characteristics.
For the longitudinal study, NIOSH
will provide participants with a pair of
new work boots of their choice, in
accordance with their respective mine
requirements and policies. Afterwards,
participants will complete a preliminary
survey and provide some basic
demographic information, details of
their current work boots, and details of
STF incidents in the past 3 months.
Participants will be requested to wear
the supplied boots at work and treat the
boots as they would any pair of work
boots they would commonly wear at
work.
NIOSH researchers will scan the boot
outsoles longitudinally, at two to three
month intervals for the length of the
study. To better understand wear
patterns and risks, participants will
complete a recurring survey that records
hours worked, locations commonly
visited, and tasks performed along with
details of any near miss or STF events.
These self-reports will be collected via
survey on a bi-weekly basis. Participants
will be offered multiple modalities to
respond to the survey (in-person, on
paper, over the telephone, via email or
using an online survey) to increase
response rates. When a participant feels
their boots need to be replaced (or when
the end of the two-year tracking period
has been reached), and at the end of the
study, they will complete a final survey
assessing why the boots were at the end
of their life and will return their boots
to NIOSH researchers for further
analysis.
For the cross-sectional study,
participants’ current work boots will be
scanned and participants will complete
the preliminary survey that includes
basic demographic information, details
of current work boots, and details of
STF events in the past three months.
The results of these research studies
will have very different applications,
but one goal: Reducing the risks of STF
accidents at surface mining facilities.
The methods adopted were adequate to
address the research questions, and
based on a thematic analysis of the data,
NIOSH will be able to identify elements
of ingress/egress systems on mobile
equipment that pose a risk of STFs. The
findings of this work were validated
against findings from an analysis of
MSHA injury data related to front-end
loaders (Nasarwanji, Pollard & Porter,
2018). A publication will be drafted
based on the results that also includes
ways to make mobile equipment.
The extension is requested to help
complete data collection for the boot
outsole wear study. The results of the
boot outsole wear study will be used to
inform mine policy and practices by
providing miners and mine managers
with the knowledge to determine when
to replace footwear based on measurable
features of the boot outsoles. The total
estimated burden hours are 643. There
is no cost to the respondents other than
their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Mobile equipment Operators ..........................
Mobile equipment operators focus group
guide.
Mobile equipment operator interview guide ...
Mine Management Interview Guide ...............
Screening Questionnaire ................................
Informed consent form(Longitudinal boot
outsole study).
Preliminary .....................................................
survey .............................................................
Recurring survey ............................................
Final Survey ...................................................
Talent and consent waiver .............................
Mobile equipment operators ...........................
Mine Management ..........................................
Mine Worker ....................................................
Mine Worker ....................................................
Mine Worker ....................................................
jspears on DSK30JT082PROD with NOTICES
Number of
respondents
Type of Respondents
Mine Worker ....................................................
Mine Worker ....................................................
Mine Worker ....................................................
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17:54 Jul 24, 2019
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Sfmt 4703
E:\FR\FM\25JYN1.SGM
Number of
responses per
respondent
Average
burden per
response
(in hours)
25
1
75/60
10
15
50
50
1
1
1
1
45/60
45/60
6/60
12/60
150
1
15/60
50
50
150
52
1
1
12/60
6/60
6/60
25JYN1
35868
Federal Register / Vol. 84, No. 143 / Thursday, July 25, 2019 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–15818 Filed 7–24–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2769]
21st Century Cures: Announcing the
Establishment of the BEST Resource
Taxonomy; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of docket;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the establishment of a
public docket to receive comments from
interested parties (including academic
institutions, regulated industry, and
patient groups) on the Agency’s
publication of a glossary of terms which
is part of the BEST (Biomarkers,
EndpointS, and other Tools) Resource
Taxonomy. FDA has developed a web
page that describes the BEST Resource
Taxonomy and links out to the official
National Library of Medicine web page
for the BEST glossary of terms.
Comments on the BEST Resource
Taxonomy will help FDA enhance its
utility and may assist FDA in
developing future versions of this
resource and identifying best methods
for conveying information about
biomarkers, endpoints, and other drug
development tools to the general public.
DATES: Submit either electronic or
written comments on this notice by
September 23, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before September 23,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 23, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
jspears on DSK30JT082PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
VerDate Sep<11>2014
17:54 Jul 24, 2019
Jkt 247001
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–2769 for ‘‘21st Century Cures:
Announcing the Establishment of the
BEST Resource Taxonomy.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Christopher Leptak, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6461,
Silver Spring, MD 20993–0002, 301–
796–0017, Christopher.Leptak@
fda.hhs.gov; or Stephen Ripley, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
Section 3011 of the 21st Century
Cures Act (Pub. L. 114–255) added a
new section 507 to the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 357).
Section 3011(b)(3)(A) requires FDA to
collaborate with biomedical research
consortia and other interested parties to
‘‘establish a taxonomy for the
classification of biomarkers (and related
scientific concepts) for use in drug
development.’’ FDA is meeting this
legislative requirement through updates
to the BEST Resource on the National
Library of Medicine website, available at
https://www.ncbi.nlm.nih.gov/books/
NBK326791/, is FDA’s response to this
E:\FR\FM\25JYN1.SGM
25JYN1
]]>Agencies
[Federal Register Volume 84, Number 143 (Thursday, July 25, 2019)]
[Notices]
[Pages 35866-35868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15818]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-19-1125]
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 ``Ingress/egress and work boot outsole wear
investigation at surface mines'' 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 March 20, 2019 to obtain comments from the public and
affected agencies. CDC received one comment 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.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. 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
Ingress/egress and work boot outsole wear investigation at surface
mines--Extension--National Institute for Occupational Safety and Health
(NIOSH), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The mission of the National Institute for Occupational Safety and
Health (NIOSH) is to promote safety & health at work for all people
through research and prevention. NIOSH, under Public Law 91-173 as
amended by Public Law 95-164 (Federal Mine Safety and Health Act of
1977) has the responsibility to conduct research to improve working
conditions and to prevent accidents and occupational diseases in the
U.S. mining sector. The goal of the proposed project is to investigate
how ingress/egress systems on mobile equipment, and personal protective
footwear (boots) used by miners may lead to slips, trips and falls at
stone, sand and gravel surface mining facilities. NIOSH is requesting a
two-year extension for this data collection.
The project objective will be achieved through two studies. The
first study aims to: identify elements of ingress/egress systems on
haulage trucks and front end loaders that pose a risk of slips, trips,
and falls (STFs) and could lead to STF related injuries; to determine
worker behavior associated with STF incidents; and to learn how
purchasing/maintenance decisions are made for ingress/egress systems.
In the surface mining industry, it is still unclear which component of
the ingress/egress system poses the greatest risk for STF. Hence, there
is a need to understand where, how, and why STF incidents occur during
ingress/egress on mobile equipment.
NIOSH will conduct semi-structured interviews and focus groups with
mobile equipment operators, and interviews will be conducted with mine
management to explore the issues
[[Page 35867]]
identified above. Focus groups will be conducted in a private setting
with 4-6 participants using a predefined list of questions to help
guide the discussion. Semi-structured interviews will be conducted
either in person or over the telephone. Two separate interview guides
will be used for mobile equipment operators and mine management to
guide the discussion.
For the focus groups and semi-structured interviews, NIOSH will
collect basic demographic information including years of mining
experience, years of experience with haul trucks/front end loaders, and
models of haul trucks/front end loaders operated most often in the past
year. The semi-structured interviews and focus groups will be audio
recorded for further analysis of the discussion. The semi-structured
interviews will last no longer than 60 minutes and the focus groups
will last no longer than 90 minutes.
The second study aims to identify changes in tread (wear) on the
work boot outsoles and other outsole characteristics of the boot
outsole that will be used to develop guidelines for work boot
replacement based on measureable features of boot outsoles. This
information will also be used in further analysis to determine
desirable and undesirable features of work boots based on mine
characteristics or job activities. Most mining companies replace
footwear at a pre-determined interval or based on appearance and
comfort with little knowledge on the actual condition of the boot
outsole and its influence on the likelihood of a STF incident. Although
there have been attempts to quantify shoe outsole wear in industrial
work when the shoe was ready for disposal, there is a lack of knowledge
in the mining industry on how quickly the outsoles of work boots wear,
what sorts of wear occurs, and how wear patterns influence the
likelihood of a STF. This study aims to address this concern through
two parts: A longitudinal study of boot outsole wear characteristics
and a cross-sectional evaluation of boot outsole characteristics.
For the longitudinal study, NIOSH will provide participants with a
pair of new work boots of their choice, in accordance with their
respective mine requirements and policies. Afterwards, participants
will complete a preliminary survey and provide some basic demographic
information, details of their current work boots, and details of STF
incidents in the past 3 months. Participants will be requested to wear
the supplied boots at work and treat the boots as they would any pair
of work boots they would commonly wear at work.
NIOSH researchers will scan the boot outsoles longitudinally, at
two to three month intervals for the length of the study. To better
understand wear patterns and risks, participants will complete a
recurring survey that records hours worked, locations commonly visited,
and tasks performed along with details of any near miss or STF events.
These self-reports will be collected via survey on a bi-weekly basis.
Participants will be offered multiple modalities to respond to the
survey (in-person, on paper, over the telephone, via email or using an
online survey) to increase response rates. When a participant feels
their boots need to be replaced (or when the end of the two-year
tracking period has been reached), and at the end of the study, they
will complete a final survey assessing why the boots were at the end of
their life and will return their boots to NIOSH researchers for further
analysis.
For the cross-sectional study, participants' current work boots
will be scanned and participants will complete the preliminary survey
that includes basic demographic information, details of current work
boots, and details of STF events in the past three months.
The results of these research studies will have very different
applications, but one goal: Reducing the risks of STF accidents at
surface mining facilities. The methods adopted were adequate to address
the research questions, and based on a thematic analysis of the data,
NIOSH will be able to identify elements of ingress/egress systems on
mobile equipment that pose a risk of STFs. The findings of this work
were validated against findings from an analysis of MSHA injury data
related to front-end loaders (Nasarwanji, Pollard & Porter, 2018). A
publication will be drafted based on the results that also includes
ways to make mobile equipment.
The extension is requested to help complete data collection for the
boot outsole wear study. The results of the boot outsole wear study
will be used to inform mine policy and practices by providing miners
and mine managers with the knowledge to determine when to replace
footwear based on measurable features of the boot outsoles. The total
estimated burden hours are 643. There is no cost to the respondents
other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of Respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Mobile equipment Operators............ Mobile equipment 25 1 75/60
operators focus group
guide.
Mobile equipment operators............ Mobile equipment 10 1 45/60
operator interview
guide.
Mine Management....................... Mine Management 15 1 45/60
Interview Guide.
Mine Worker........................... Screening Questionnaire. 50 1 6/60
Mine Worker........................... Informed consent 50 1 12/60
form(Longitudinal boot
outsole study).
Mine Worker........................... Preliminary............. 150 1 15/60
survey..................
Mine Worker........................... Recurring survey........ 50 52 12/60
Mine Worker........................... Final Survey............ 50 1 6/60
Mine Worker........................... Talent and consent 150 1 6/60
waiver.
----------------------------------------------------------------------------------------------------------------
[[Page 35868]]
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-15818 Filed 7-24-19; 8:45 am]
BILLING CODE 4163-18-P
