60 day FRN

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productivity of the program; and (3)
increase transparency so issues are
identified early in the process.
Information about this program is
available at: https://www.epa.gov/iris.
Availability of Meeting Materials:
Additional background on this SAB
activity, the meeting agenda, and other
materials for the meeting will be posted
on the SAB Web site at http://
www.epa.gov/sab.
Procedures for Providing Public Input:
Public comment for consideration by
EPA’s federal advisory committees and
panels has a different purpose from
public comment provided to EPA
program offices. Therefore, the process
for submitting comments to a federal
advisory committee is different from the
process used to submit comments to an
EPA program office. Federal advisory
committees and panels, including
scientific advisory committees, provide
independent advice to the EPA.
Members of the public can submit
relevant comments pertaining to the
meeting materials or the group
conducting this SAB activity. Input
from the public to the SAB will have the
most impact if it consists of comments
that provide specific scientific or
technical information or analysis for
SAB committees and panels to consider
or if it relates to the clarity or accuracy
of the technical information. Members
of the public wishing to provide
comment should contact the DFO
directly.
Oral Statements: In general,
individuals or groups requesting an oral
presentation at a public meeting will be
limited to five minutes per speaker.
Interested parties wishing to provide
comments should contact Dr. Suhair
Shallal, DFO (preferably via email) at
the contact information noted above by
September 20, 2017, to be placed on the
list of public speakers for the meeting.
Written Statements: Written
statements will be accepted throughout
the advisory process; however, for
timely consideration by Committee
members, statements should be
supplied to the DFO (preferably via
email) at the contact information noted
above by September 20, 2017. It is the
SAB Staff Office general policy to post
written comments on the Web page for
the advisory meeting. Submitters are
requested to provide an unsigned
version of each document because the
SAB Staff Office does not publish
documents with signatures on its Web
sites. Members of the public should be
aware that their personal contact
information, if included in any written
comments, may be posted to the SAB
Web site. Copyrighted material will not

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be posted without explicit permission of
the copyright holder.
Accessibility: For information on
access or services for individuals with
disabilities, please contact Dr. Suhair
Shallal at (202) 564–0257 or at
[email protected]. To request
accommodation of a disability, please
contact Dr. Shallal preferably at least ten
days prior to the meeting, to give EPA
as much time as possible to process
your request.
Dated: August 21, 2017.
Christopher Zarba,
Director, EPA Science Advisory Board Staff
Office.
[FR Doc. 2017–18764 Filed 9–5–17; 8:45 am]
BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–17–17AUQ; Docket No. CDC–2017–
0064]

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 Mobile Proximity Initial
User Feedback information collection
project.
DATES: Written comments must be
received on or before November 6, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2017–
0064 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
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
SUMMARY:

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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 Leroy A.
Richardson, Information Collection
Review Office, Centers for Disease
Control and 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.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of

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Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
Mobile Proximity Initial User
Feedback—New—National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).

asabaliauskas on DSKBBXCHB2PROD with NOTICES

Background and Brief Description
As a part of The National Institute for
Occupational Safety and Health
(NIOSH) Pittsburgh Mining Research
Division (PMRD) project Design of
Proximity Systems for Underground
Mobile Equipment, NIOSH researchers
are looking to assess the current state of
proximity systems being used by
industry. In conjunction with
performance based testing, researchers
are examining the human factors aspects
of the systems and their
implementations. NIOSH is requesting a
three-year OMB approval to collect
information.
Striking, pinning, and crushing
injuries are a serious concern in
underground coal mining, especially
around mobile equipment. Between
2010 and 2014 powered haulage
accounted for 24 of the 110
underground coal fatalities (NIOSH,
2016). During that same time period, the
Mine Safety and Health Administration
(MSHA) determined that up to 9 of
these fatalities were striking, pinning, or
crushing accidents that may have been
prevented by proximity detection
systems on coal haulage machines or
scoops (MSHA, 2016a). Following the
final rule requiring proximity detection
systems on continuous mining
machines, on September 2, 2015, MSHA
published a proposed rule requiring
proximity systems on mobile machines
in underground coal mines (MSHA,
2015a; 2015b). Though the rule is still
under development, MSHA reported
that by June of 2015, 155 of
approximately 2,116 coal haulage
machines and scoops had been

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study identified a need for additional
research related to the performance of
proximity detection systems on mobile
equipment. Even though the pilot study
and related, subsequent studies offer
findings, which may potentially
compliment findings from the proposed
study, these studies were not
specifically designed to focus on human
factors. Conversely, the proposed study
focuses on human factors influencing
the safety and effectiveness of proximity
systems installed on underground
mobile equipment.
The proposed research study involves
conducting semi-structured interviews
and optional observations of regularly
assigned job duties with a maximum of
250 mining crew members. To recruit
the mines, operators will be contacted.
The recruitment conversation is
expected to last 15 minutes.
Up to 250, 10-minute, semi-structured
interviews will be conducted to collect
workers’ experiences with and
perspectives on current proximity
detection systems on mobile haulage
equipment. To capture a variety of
perspectives, various members of the
section crews will be invited to
participate in the interviews.
Prior to the interview, miners will be
read a verbal informed consent and
asked to give verbal affirmation that
they agree to participate in the study.
Workers that do not wish to participate
will be given the opportunity to leave.
Following the interviews, a subset of
mine workers will be observed as a
section crew of 7 to 13 individuals
performing their normal duties for an
hour during their shift. The observation
component is optional for the
individuals. Since the participant will
be performing regular job duties during
the observation, this does not require
any additional time from the
participant. To observe crew members
in a designated section, researchers will
obtain verbal consent from all miners
who may be observed. If a crew member
working in a designated section chooses
to be excluded from the study, the
section will not be observed.
Observation will focus on general
behavior with and around the proximity
system.
The total estimated time burden is 44
hours. There are no costs to respondents
other than their time.

equipped with proximity detection
systems (MSHA, 2016b).
On January 9 of 2017, MSHA
reopened the comment period for
equipping underground mobile
machines with proximity detection
systems. MSHA reopened the comment
period for two key reasons. First, MSHA
reopened the comment period to
explore any additional comments raised
during or following the closing of the
original comment period. Second,
MSHA reopened the comment period to
allow for comments on a field-report on
proximity detection system utilization
in South Africa, which was conducted
following the original comment period
and presented at the June 22, 2016
NIOSH Proximity Detection Partnership
Meeting. Some of concerns raised were
related to the potential risks that
proximity detection systems on mobile
equipment might pose for mine workers.
The comments included risk such as
those associated with performing
routine maintenance and
troubleshooting tasks, machine
movements, which may result in
pinning, crushing, or striking accidents,
and sudden equipment stops which may
harm machine operators.
NIOSH researchers are looking to
determine the critical use cases for
proximity systems on mobile equipment
in underground mines. Researchers
would like to answer the following
questions: (1) In which situations do
proximity detection systems on mobile
haulage hinder normal operation? and
(2) in which situations do proximity
detection systems on mobile haulage
endanger miners? Researchers are also
interested in determining what factors
should be considered related to human
machine interfaces when implementing
proximity systems on mobile equipment
in underground mines. Specifically,
researchers hope to answer the
following questions: (1) What is the
expected behavior of a proximity
detection system on mobile haulage?
and (2) What are the desired user
features of a proximity detection system
on mobile haulage?
Previously, NIOSH conducted a pilot
study on proximity detection systems
on mobile equipment used in
underground coal mines. The pilot
study involved determining the required
stopping distances and times for mobile
equipment. Findings from the pilot

ESTIMATED ANNUALIZED BURDEN HOURS
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Mine Operators .................................

Mine Recruitment Script ...................

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Number of
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(in hours)
15/60

Total burden
(in hours)
2

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ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

Crew Members ..................................

Interview protocol .............................

250

1

10/60

42

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

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

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

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

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

44

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2017–18814 Filed 9–5–17; 8:45 am]

Development of a List of Pre-Dietary
Supplement Health and Education Act
Dietary Ingredients; Public Meeting;
Request for Comments

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Notice of public meeting;
request for comments.

Food and Drug Administration,

Notice; correction.

The Food and Drug
Administration (FDA) is correcting a
document entitled ‘‘B. Braun Medical,
Inc.; Withdrawal of Approval of Three
New Drug Applications and One
Abbreviated New Drug Application’’
that appeared in the Federal Register of
August 3, 2017 (82 FR 36150). The
document was published with the
incorrect docket number. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lisa
Granger, Office of Policy, Food and Drug
Administration, Bldg. 32, Rm. 3330,
Silver Spring, MD 20993–0002, 301–
796–9115.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Thursday, August 3,
2017, in FR Doc. 2017–16377, on page
36150, the following correction is made:
1. On page 36150, in the second
column, in the header of the document,
‘‘Docket No. FDA–2017–N–0002’’ is
corrected to read ‘‘Docket No. FDA–
2017–N–4642’’.
Dated: August 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–18813 Filed 9–5–17; 8:45 am]
BILLING CODE 4164–01–P

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The Food and Drug
Administration (FDA or we) is
announcing the following public
meeting entitled ‘‘Development of a List
of Pre-DSHEA Dietary Ingredients.’’ The
purpose of the meeting is to give
interested stakeholders an opportunity
to discuss issues related to FDA’s future
development of such a list.
DATES: The public meeting will be held
on October 3, 2017, from 8 a.m. to 5
p.m. Submit either electronic or written
comments on this public meeting by
December 4, 2017. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be
held at FDA’s Center for Food Safety
and Applied Nutrition, Wiley
Auditorium, 5001 Campus Dr., College
Park, MD 20740.
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 December 4, 2017. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of December 4, 2017. 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.
SUMMARY:

HHS.
SUMMARY:

Food and Drug Administration,

ACTION:

B. Braun Medical, Inc.; Withdrawal of
Approval of Three New Drug
Applications and One Abbreviated New
Drug Application; Correction

ACTION:

[Docket No. FDA–2017–N–4625]

HHS.

[Docket No. FDA–2017–N–4642]

AGENCY:

Food and Drug Administration

AGENCY:

Food and Drug Administration

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Number of
respondents

Type of respondents

Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the

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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–
2017–N–4625 for ‘‘Development of a
List of Pre-DSHEA Dietary Ingredients;
Public Meeting; Request for Comments.’’
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

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