82_FR_42267 82 FR 42096 - Proposed Data Collection Submitted for Public Comment and Recommendations

82 FR 42096 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 82, Issue 171 (September 6, 2017)

Page Range42096-42098
FR Document2017-18814

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.

Federal Register, Volume 82 Issue 171 (Wednesday, September 6, 2017)
[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Pages 42096-42098]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-18814]


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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: 
[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

[[Page 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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Mine Operators................  Mine Recruitment               6               1           15/60               2
                                 Script.

[[Page 42098]]

 
Crew Members..................  Interview                    250               1           10/60              42
                                 protocol.
                                                 ---------------------------------------------------------------
    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



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

                                                    productivity of the program; and (3)                    be posted without explicit permission of              to Regulations.gov, including any
                                                    increase transparency so issues are                     the copyright holder.                                 personal information provided. For
                                                    identified early in the process.                          Accessibility: For information on                   access to the docket to read background
                                                    Information about this program is                       access or services for individuals with               documents or comments received, go to
                                                    available at: https://www.epa.gov/iris.                 disabilities, please contact Dr. Suhair               Regulations.gov.
                                                       Availability of Meeting Materials:                   Shallal at (202) 564–0257 or at                          Please note: All public comment
                                                    Additional background on this SAB                       shallal.suhair@epa.gov. To request                    should be submitted through the
                                                    activity, the meeting agenda, and other                 accommodation of a disability, please                 Federal eRulemaking portal
                                                    materials for the meeting will be posted                contact Dr. Shallal preferably at least ten           (Regulations.gov) or by U.S. mail to the
                                                    on the SAB Web site at http://                          days prior to the meeting, to give EPA                address listed above.
                                                    www.epa.gov/sab.                                        as much time as possible to process                   FOR FURTHER INFORMATION CONTACT: To
                                                       Procedures for Providing Public Input:               your request.                                         request more information on the
                                                    Public comment for consideration by                       Dated: August 21, 2017.                             proposed project or to obtain a copy of
                                                    EPA’s federal advisory committees and                   Christopher Zarba,                                    the information collection plan and
                                                    panels has a different purpose from                     Director, EPA Science Advisory Board Staff            instruments, contact Leroy A.
                                                    public comment provided to EPA                          Office.                                               Richardson, Information Collection
                                                    program offices. Therefore, the process                 [FR Doc. 2017–18764 Filed 9–5–17; 8:45 am]            Review Office, Centers for Disease
                                                    for submitting comments to a federal                    BILLING CODE 6560–50–P
                                                                                                                                                                  Control and Prevention, 1600 Clifton
                                                    advisory committee is different from the                                                                      Road NE., MS–D74, Atlanta, Georgia
                                                    process used to submit comments to an                                                                         30329; phone: 404–639–7570; Email:
                                                    EPA program office. Federal advisory                                                                          omb@cdc.gov.
                                                                                                            DEPARTMENT OF HEALTH AND
                                                    committees and panels, including                                                                              SUPPLEMENTARY INFORMATION: Under the
                                                                                                            HUMAN SERVICES
                                                    scientific advisory committees, provide                                                                       Paperwork Reduction Act of 1995 (PRA)
                                                    independent advice to the EPA.                          Centers for Disease Control and                       (44 U.S.C. 3501–3520), Federal agencies
                                                    Members of the public can submit                        Prevention                                            must obtain approval from the Office of
                                                    relevant comments pertaining to the                                                                           Management and Budget (OMB) for each
                                                    meeting materials or the group                          [60-Day–17–17AUQ; Docket No. CDC–2017–                collection of information they conduct
                                                    conducting this SAB activity. Input                     0064]
                                                                                                                                                                  or sponsor. In addition, the PRA also
                                                    from the public to the SAB will have the                                                                      requires Federal agencies to provide a
                                                                                                            Proposed Data Collection Submitted
                                                    most impact if it consists of comments                                                                        60-day notice in the Federal Register
                                                                                                            for Public Comment and
                                                    that provide specific scientific or                                                                           concerning each proposed collection of
                                                                                                            Recommendations
                                                    technical information or analysis for                                                                         information, including each new
                                                    SAB committees and panels to consider                   AGENCY: Centers for Disease Control and               proposed collection, each proposed
                                                    or if it relates to the clarity or accuracy             Prevention (CDC), Department of Health                extension of existing collection of
                                                    of the technical information. Members                   and Human Services (HHS).                             information, and each reinstatement of
                                                    of the public wishing to provide                        ACTION: Notice with comment period.                   previously approved information
                                                    comment should contact the DFO                                                                                collection before submitting the
                                                    directly.                                               SUMMARY:    The Centers for Disease                   collection to OMB for approval. To
                                                       Oral Statements: In general,                         Control and Prevention (CDC), as part of              comply with this requirement, we are
                                                    individuals or groups requesting an oral                its continuing efforts to reduce public               publishing this notice of a proposed
                                                    presentation at a public meeting will be                burden and maximize the utility of                    data collection as described below.
                                                    limited to five minutes per speaker.                    government information, invites the                      Comments are invited on: (a) Whether
                                                    Interested parties wishing to provide                   general public and other Federal                      the proposed collection of information
                                                    comments should contact Dr. Suhair                      agencies to take this opportunity to                  is necessary for the proper performance
                                                    Shallal, DFO (preferably via email) at                  comment on proposed and/or                            of the functions of the agency, including
                                                    the contact information noted above by                  continuing information collections, as                whether the information shall have
                                                    September 20, 2017, to be placed on the                 required by the Paperwork Reduction                   practical utility; (b) the accuracy of the
                                                    list of public speakers for the meeting.                Act of 1995. This notice invites                      agency’s estimate of the burden of the
                                                       Written Statements: Written                          comment on Mobile Proximity Initial                   proposed collection of information; (c)
                                                    statements will be accepted throughout                  User Feedback information collection                  ways to enhance the quality, utility, and
                                                    the advisory process; however, for                      project.                                              clarity of the information to be
                                                    timely consideration by Committee                       DATES: Written comments must be                       collected; (d) ways to minimize the
                                                    members, statements should be                           received on or before November 6, 2017.               burden of the collection of information
                                                    supplied to the DFO (preferably via                     ADDRESSES: You may submit comments,                   on respondents, including through the
                                                    email) at the contact information noted                 identified by Docket No. CDC–2017–                    use of automated collection techniques
                                                    above by September 20, 2017. It is the                  0064 by any of the following methods:                 or other forms of information
                                                    SAB Staff Office general policy to post                    • Federal eRulemaking Portal:                      technology; and (e) estimates of capital
                                                    written comments on the Web page for                    Regulations.gov. Follow the instructions              or start-up costs and costs of operation,
                                                    the advisory meeting. Submitters are                    for submitting comments.                              maintenance, and purchase of services
                                                                                                               • Mail: Leroy A. Richardson,
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                    requested to provide an unsigned                                                                              to provide information. Burden means
                                                    version of each document because the                    Information Collection Review Office,                 the total time, effort, or financial
                                                    SAB Staff Office does not publish                       Centers for Disease Control and                       resources expended by persons to
                                                    documents with signatures on its Web                    Prevention, 1600 Clifton Road NE., MS–                generate, maintain, retain, disclose or
                                                    sites. Members of the public should be                  D74, Atlanta, Georgia 30329.                          provide information to or for a Federal
                                                    aware that their personal contact                          Instructions: All submissions received             agency. This includes the time needed
                                                    information, if included in any written                 must include the agency name and                      to review instructions; to develop,
                                                    comments, may be posted to the SAB                      Docket Number. All relevant comments                  acquire, install and utilize technology
                                                    Web site. Copyrighted material will not                 received will be posted without change                and systems for the purpose of


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                                                                                 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices                                                 42097

                                                    collecting, validating and verifying                          equipped with proximity detection                      study identified a need for additional
                                                    information, processing and                                   systems (MSHA, 2016b).                                 research related to the performance of
                                                    maintaining information, and disclosing                          On January 9 of 2017, MSHA                          proximity detection systems on mobile
                                                    and providing information; to train                           reopened the comment period for                        equipment. Even though the pilot study
                                                    personnel and to be able to respond to                        equipping underground mobile                           and related, subsequent studies offer
                                                    a collection of information, to search                        machines with proximity detection                      findings, which may potentially
                                                    data sources, to complete and review                          systems. MSHA reopened the comment                     compliment findings from the proposed
                                                    the collection of information; and to                         period for two key reasons. First, MSHA                study, these studies were not
                                                    transmit or otherwise disclose the                            reopened the comment period to                         specifically designed to focus on human
                                                    information.                                                  explore any additional comments raised                 factors. Conversely, the proposed study
                                                                                                                  during or following the closing of the                 focuses on human factors influencing
                                                    Proposed Project                                              original comment period. Second,                       the safety and effectiveness of proximity
                                                      Mobile Proximity Initial User                               MSHA reopened the comment period to                    systems installed on underground
                                                    Feedback—New—National Institute for                           allow for comments on a field-report on                mobile equipment.
                                                    Occupational Safety and Health                                proximity detection system utilization                    The proposed research study involves
                                                    (NIOSH), Centers for Disease Control                          in South Africa, which was conducted                   conducting semi-structured interviews
                                                    and Prevention (CDC).                                         following the original comment period                  and optional observations of regularly
                                                                                                                  and presented at the June 22, 2016                     assigned job duties with a maximum of
                                                    Background and Brief Description                              NIOSH Proximity Detection Partnership                  250 mining crew members. To recruit
                                                       As a part of The National Institute for                    Meeting. Some of concerns raised were                  the mines, operators will be contacted.
                                                    Occupational Safety and Health                                related to the potential risks that                    The recruitment conversation is
                                                    (NIOSH) Pittsburgh Mining Research                            proximity detection systems on mobile                  expected to last 15 minutes.
                                                    Division (PMRD) project Design of                             equipment might pose for mine workers.                    Up to 250, 10-minute, semi-structured
                                                    Proximity Systems for Underground                             The comments included risk such as                     interviews will be conducted to collect
                                                    Mobile Equipment, NIOSH researchers                           those associated with performing                       workers’ experiences with and
                                                    are looking to assess the current state of                    routine maintenance and
                                                                                                                                                                         perspectives on current proximity
                                                    proximity systems being used by                               troubleshooting tasks, machine
                                                                                                                                                                         detection systems on mobile haulage
                                                                                                                  movements, which may result in
                                                    industry. In conjunction with                                                                                        equipment. To capture a variety of
                                                                                                                  pinning, crushing, or striking accidents,
                                                    performance based testing, researchers                                                                               perspectives, various members of the
                                                                                                                  and sudden equipment stops which may
                                                    are examining the human factors aspects                                                                              section crews will be invited to
                                                                                                                  harm machine operators.
                                                    of the systems and their                                         NIOSH researchers are looking to                    participate in the interviews.
                                                    implementations. NIOSH is requesting a                        determine the critical use cases for                      Prior to the interview, miners will be
                                                    three-year OMB approval to collect                            proximity systems on mobile equipment                  read a verbal informed consent and
                                                    information.                                                  in underground mines. Researchers                      asked to give verbal affirmation that
                                                       Striking, pinning, and crushing                            would like to answer the following                     they agree to participate in the study.
                                                    injuries are a serious concern in                             questions: (1) In which situations do                  Workers that do not wish to participate
                                                    underground coal mining, especially                           proximity detection systems on mobile                  will be given the opportunity to leave.
                                                    around mobile equipment. Between                              haulage hinder normal operation? and                   Following the interviews, a subset of
                                                    2010 and 2014 powered haulage                                 (2) in which situations do proximity                   mine workers will be observed as a
                                                    accounted for 24 of the 110                                   detection systems on mobile haulage                    section crew of 7 to 13 individuals
                                                    underground coal fatalities (NIOSH,                           endanger miners? Researchers are also                  performing their normal duties for an
                                                    2016). During that same time period, the                      interested in determining what factors                 hour during their shift. The observation
                                                    Mine Safety and Health Administration                         should be considered related to human                  component is optional for the
                                                    (MSHA) determined that up to 9 of                             machine interfaces when implementing                   individuals. Since the participant will
                                                    these fatalities were striking, pinning, or                   proximity systems on mobile equipment                  be performing regular job duties during
                                                    crushing accidents that may have been                         in underground mines. Specifically,                    the observation, this does not require
                                                    prevented by proximity detection                              researchers hope to answer the                         any additional time from the
                                                    systems on coal haulage machines or                           following questions: (1) What is the                   participant. To observe crew members
                                                    scoops (MSHA, 2016a). Following the                           expected behavior of a proximity                       in a designated section, researchers will
                                                    final rule requiring proximity detection                      detection system on mobile haulage?                    obtain verbal consent from all miners
                                                    systems on continuous mining                                  and (2) What are the desired user                      who may be observed. If a crew member
                                                    machines, on September 2, 2015, MSHA                          features of a proximity detection system               working in a designated section chooses
                                                    published a proposed rule requiring                           on mobile haulage?                                     to be excluded from the study, the
                                                    proximity systems on mobile machines                             Previously, NIOSH conducted a pilot                 section will not be observed.
                                                    in underground coal mines (MSHA,                              study on proximity detection systems                   Observation will focus on general
                                                    2015a; 2015b). Though the rule is still                       on mobile equipment used in                            behavior with and around the proximity
                                                    under development, MSHA reported                              underground coal mines. The pilot                      system.
                                                    that by June of 2015, 155 of                                  study involved determining the required                   The total estimated time burden is 44
                                                    approximately 2,116 coal haulage                              stopping distances and times for mobile                hours. There are no costs to respondents
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                    machines and scoops had been                                  equipment. Findings from the pilot                     other than their time.

                                                                                                                 ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                            Average
                                                                                                                                                                         Number of
                                                                                                                                                      Number of                           burden per     Total burden
                                                              Type of respondents                                    Form name                                         responses per
                                                                                                                                                     respondents                           response       (in hours)
                                                                                                                                                                         respondent        (in hours)

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



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                                                    42098                           Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices

                                                                                                              ESTIMATED ANNUALIZED BURDEN HOURS—Continued
                                                                                                                                                                                                                                      Average
                                                                                                                                                                                                        Number of
                                                                                                                                                                             Number of                                              burden per              Total burden
                                                              Type of respondents                                                Form name                                                            responses per
                                                                                                                                                                            respondents                                              response                (in hours)
                                                                                                                                                                                                        respondent                   (in hours)

                                                    Crew Members ..................................          Interview protocol .............................                                250                           1                    10/60                 42

                                                         Total ...........................................   ...........................................................   ........................   ........................   ........................             44



                                                    Leroy A. Richardson,                                                    DEPARTMENT OF HEALTH AND                                                      instructions for submitting comments.
                                                    Chief, Information Collection Review Office,                            HUMAN SERVICES                                                                Comments submitted electronically,
                                                    Office of Scientific Integrity, Office of the                                                                                                         including attachments, to https://
                                                    Associate Director for Science, Office of the                           Food and Drug Administration                                                  www.regulations.gov will be posted to
                                                    Director, Centers for Disease Control and                                                                                                             the docket unchanged. Because your
                                                    Prevention.                                                             [Docket No. FDA–2017–N–4625]
                                                                                                                                                                                                          comment will be made public, you are
                                                    [FR Doc. 2017–18814 Filed 9–5–17; 8:45 am]                                                                                                            solely responsible for ensuring that your
                                                                                                                            Development of a List of Pre-Dietary
                                                    BILLING CODE 4163–18–P                                                  Supplement Health and Education Act                                           comment does not include any
                                                                                                                            Dietary Ingredients; Public Meeting;                                          confidential information that you or a
                                                                                                                            Request for Comments                                                          third party may not wish to be posted,
                                                    DEPARTMENT OF HEALTH AND                                                                                                                              such as medical information, your or
                                                    HUMAN SERVICES                                                          AGENCY:         Food and Drug Administration,                                 anyone else’s Social Security number, or
                                                                                                                            HHS.                                                                          confidential business information, such
                                                    Food and Drug Administration                                            ACTION: Notice of public meeting;                                             as a manufacturing process. Please note
                                                                                                                            request for comments.                                                         that if you include your name, contact
                                                    [Docket No. FDA–2017–N–4642]                                                                                                                          information, or other information that
                                                                                                                            SUMMARY:   The Food and Drug
                                                                                                                                                                                                          identifies you in the body of your
                                                    B. Braun Medical, Inc.; Withdrawal of                                   Administration (FDA or we) is
                                                                                                                                                                                                          comments, that information will be
                                                    Approval of Three New Drug                                              announcing the following public
                                                                                                                                                                                                          posted on https://www.regulations.gov.
                                                    Applications and One Abbreviated New                                    meeting entitled ‘‘Development of a List
                                                                                                                                                                                                            • If you want to submit a comment
                                                    Drug Application; Correction                                            of Pre-DSHEA Dietary Ingredients.’’ The
                                                                                                                                                                                                          with confidential information that you
                                                                                                                            purpose of the meeting is to give
                                                    AGENCY:      Food and Drug Administration,                                                                                                            do not wish to be made available to the
                                                                                                                            interested stakeholders an opportunity
                                                    HHS.                                                                                                                                                  public, submit the comment as a
                                                                                                                            to discuss issues related to FDA’s future
                                                                                                                                                                                                          written/paper submission and in the
                                                    ACTION:     Notice; correction.                                         development of such a list.
                                                                                                                                                                                                          manner detailed (see ‘‘Written/Paper
                                                                                                                            DATES: The public meeting will be held                                        Submissions’’ and ‘‘Instructions’’).
                                                    SUMMARY:   The Food and Drug                                            on October 3, 2017, from 8 a.m. to 5
                                                    Administration (FDA) is correcting a                                    p.m. Submit either electronic or written                                      Written/Paper Submissions
                                                    document entitled ‘‘B. Braun Medical,                                   comments on this public meeting by                                              Submit written/paper submissions as
                                                    Inc.; Withdrawal of Approval of Three                                   December 4, 2017. See the                                                     follows:
                                                    New Drug Applications and One                                           SUPPLEMENTARY INFORMATION section for                                           • Mail/Hand delivery/Courier (for
                                                    Abbreviated New Drug Application’’                                      registration date and information.                                            written/paper submissions): Dockets
                                                    that appeared in the Federal Register of                                ADDRESSES: The public meeting will be                                         Management Staff (HFA–305), Food and
                                                    August 3, 2017 (82 FR 36150). The                                       held at FDA’s Center for Food Safety                                          Drug Administration, 5630 Fishers
                                                    document was published with the                                         and Applied Nutrition, Wiley                                                  Lane, Rm. 1061, Rockville, MD 20852.
                                                    incorrect docket number. This                                           Auditorium, 5001 Campus Dr., College                                            • For written/paper comments
                                                    document corrects that error.                                           Park, MD 20740.                                                               submitted to the Dockets Management
                                                    FOR FURTHER INFORMATION CONTACT: Lisa                                      You may submit comments as                                                 Staff, FDA will post your comment, as
                                                    Granger, Office of Policy, Food and Drug                                follows. Please note that late, untimely                                      well as any attachments, except for
                                                    Administration, Bldg. 32, Rm. 3330,                                     filed comments will not be considered.                                        information submitted, marked and
                                                    Silver Spring, MD 20993–0002, 301–                                      Electronic comments must be submitted                                         identified, as confidential, if submitted
                                                    796–9115.                                                               on or before December 4, 2017. The                                            as detailed in ‘‘Instructions.’’
                                                    SUPPLEMENTARY INFORMATION: In the                                       https://www.regulations.gov electronic                                          Instructions: All submissions received
                                                    Federal Register of Thursday, August 3,                                 filing system will accept comments                                            must include the Docket No. FDA–
                                                    2017, in FR Doc. 2017–16377, on page                                    until midnight Eastern Time at the end                                        2017–N–4625 for ‘‘Development of a
                                                    36150, the following correction is made:                                of December 4, 2017. Comments                                                 List of Pre-DSHEA Dietary Ingredients;
                                                       1. On page 36150, in the second                                      received by mail/hand delivery/courier                                        Public Meeting; Request for Comments.’’
                                                    column, in the header of the document,                                  (for written/paper submissions) will be                                       Received comments, those filed in a
                                                    ‘‘Docket No. FDA–2017–N–0002’’ is                                       considered timely if they are                                                 timely manner (see ADDRESSES), will be
asabaliauskas on DSKBBXCHB2PROD with NOTICES




                                                    corrected to read ‘‘Docket No. FDA–                                     postmarked or the delivery service                                            placed in the docket and, except for
                                                    2017–N–4642’’.                                                          acceptance receipt is on or before that                                       those submitted as ‘‘Confidential
                                                                                                                            date.                                                                         Submissions,’’ publicly viewable at
                                                      Dated: August 28, 2017.                                                                                                                             https://www.regulations.gov or at the
                                                    Anna K. Abram,                                                          Electronic Submissions                                                        Dockets Management Staff between 9
                                                    Deputy Commissioner for Policy, Planning,                                 Submit electronic comments in the                                           a.m. and 4 p.m., Monday through
                                                    Legislation, and Analysis.                                              following way:                                                                Friday.
                                                    [FR Doc. 2017–18813 Filed 9–5–17; 8:45 am]                                • Federal eRulemaking Portal:                                                 • Confidential Submissions—To
                                                    BILLING CODE 4164–01–P                                                  https://www.regulations.gov. Follow the                                       submit a comment with confidential


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Document Created: 2017-09-06 00:56:56
Document Modified: 2017-09-06 00:56:56
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesWritten comments must be received on or before November 6, 2017.
ContactTo 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]
FR Citation82 FR 42096 

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