42096 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices 

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 

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 

shallal.suhair@epa.gov. 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 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: 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 

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: 

omb@cdc.gov. 

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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices 42097 

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). 

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 

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 

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. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Mine Operators ................................. Mine Recruitment Script ................... 6 1 15/60 2 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
42098 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

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. 

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

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4642] 

B. Braun Medical, Inc.; Withdrawal of 

Approval of Three New Drug 

Applications and One Abbreviated New 

Drug Application; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4625] 

Development of a List of Pre-Dietary 

Supplement Health and Education Act 

Dietary Ingredients; Public Meeting; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: 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. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• 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– 

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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