[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Notices]
[Pages 61035-61036]
[FR Doc No: 2017-27665]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2011-0189]

Servicing Multi-Piece and Single Piece Rim Wheels; Extension of
the Office of Management and Budget's (OMB) Approval of Information
Collection (Paperwork) Requirements

AGENCY: Occupational Safety and Health Administration, Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning its proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements specified in the Standard on
Servicing Multi-Piece and Single Piece Rim Wheels. The paperwork
provisions of the Standard includes a requirement that the manufacturer
or a Registered Professional Engineer certify that repaired restraining
devices and barriers meet the strength requirements specified in the
Standard and a requirement that defective wheels and wheel components
be marked or tagged.

DATES: Comments must be submitted (postmarked, sent, or received) by
February 26, 2018.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, Docket No. OSHA-2011-0189,
Occupational Safety and Health Administration, U.S. Department of
Labor, Room N-3653, 200 Constitution Avenue NW, Washington, DC 20210.
Deliveries (hand, express mail, messenger, and courier services) are
accepted during the Docket Office's normal business hours, 10:00 a.m.
to 3:00 p.m., ET.
    Instructions: All submissions must include the Agency name and OSHA
docket number (OSHA-2011-0189) for the Information Collection Request
(ICR). All comments, including any personal information you provide,
are placed in the public docket without change, and may be made
available online at http://www.regulations.gov. For further information
on submitting comments, see the ``Public Participation'' heading in the
section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other materials in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov_index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download from the website. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Theda Kenney at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney or Charles McCormick,
Directorate of Standards and Guidance, OSHA, U.S. Department of Labor;
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accord with the Paperwork Reduction Act of
1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651
et seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also
requires that OSHA obtain such information with minimum burden upon
employers, especially those operating small businesses, and to reduce
to the maximum extent feasible unnecessary duplication of efforts in
obtaining information (29 U.S.C. 657).
    Certification of repair (Sec.  1910.177(d)(3)(iv)). This paragraph
requires that when restraining devices and barriers are removed from
service because they are defective, they shall not be returned to
service until they are repaired and reinspected. If the repair is
structural, the manufacturer or a Registered Professional Engineer must
certify that the strength requirements specified in Sec.
1910.177(d)(3)(i) of the Standard have been met.
    The certification records are used to assure that equipment has
been properly repaired. The certification records also provide the most
efficient means for OSHA compliance officers to determine that an
employer is complying with the Standard.
    Marking or tagging of wheel components (1910.177(e)(2)). This
paragraph requires that defective wheels and wheel components ``be
marked or tagged unserviceable and removed from the service area.''
Under this requirement, OSHA is providing employers with sufficient
information from which they can derive the wording to use in marking
the object or constructing a tag. Therefore, this provision imposes no
paperwork burden because it falls within the portion of 5 CFR
1320(c)(2) that states, ``The public disclosure of information
originally supplied by the Federal government to the recipient for the
purpose of disclosure to the public is not included within this
definition [of `collection of information']''.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply.
For example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend its approval of the information
collection requirements contained in the Standard on Servicing Multi-
Piece and Single Piece Rim Wheels (29 CFR 1910.177). OSHA is proposing
to retain its current burden hour estimate of one (1) hour. The Agency
will summarize the comments submitted in response to this notice and
will include this summary in the request to OMB.
    Type of Review: Extension of a currently approved collection.
    Title: Servicing Multi-Piece and Single Piece Rim Wheels (29 CFR
1910.177).
    OMB Control Number: 1218-0219.
    Affected Public: Business or other for-profits.
    Number of Respondents: 85.
    Frequency of Responses: On occasion.
    Average Time per Response: Various.
    Estimated Total Burden Hours: 1.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other materials must identify the Agency
name and the OSHA docket number for the ICR (Docket No. OSHA-2011-
0189). You may supplement electronic submissions by uploading document
files electronically. If you wish to mail additional materials in
reference to an electronic or facsimile submission, you must submit
them to the OSHA Docket Office (see the section of this notice titled
ADDRESSES). The additional materials must clearly identify your
electronic comments by your name, date, and the docket number so the
Agency can attach them to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions comments about submitting
personal information such as social security numbers and dates of
birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publically available to read or download through this
website. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office. Information on
using the http://www.regulations.gov website to submit comments and
access the docket is available at the website's ``User Tips'' link.
Contact the OSHA Docket Office for information about materials not
available through the website, and for assistance in using the internet
to locate docket submissions.

V. Authority and Signature

    Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational
Safety and Health, directed the preparation of this notice. The
authority for this notice is the Paperwork Reduction Act of 1995 (44
U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012 (77 FR
3912).

    Signed at Washington, DC, on December 12, 2017.
Loren Sweatt,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2017-27665 Filed 12-22-17; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 84, Number 77 (Monday, April 22, 2019)]
[Notices]
[Pages 16676-16677]
[FR Doc No: 2019-08033]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1677]

Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Circulatory System Devices
Panel of the Medical Devices Advisory Committee. The general function
of the committee is to provide advice and recommendations to the Agency
on FDA's regulatory issues. The meeting will be open to the public.

DATES: The meeting will be held on June 19, 2019, from 8 a.m. to 5
p.m., and June 20, 2019, from 8 a.m. to 3 p.m.

ADDRESSES: Gaithersburg Holiday Inn, Grand Ballroom, Two Montgomery
Village Ave., Gaithersburg, MD 20879. The hotel's telephone number is
301-948-8900; additional information is available online at: https://www.ihg.com/holidayinn/hotels/us/en/gaithersburg/wasrv/hoteldetail?cm_mmc=Google. Answers to commonly asked questions
including information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Evella Washington, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD 20993-0002,
[email protected],<PHONE_NUMBER>, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER>) in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On June 19 and 20, 2019, the committee will discuss and
make recommendations on information related to recent observations of
increased long-term mortality in peripheral arterial disease patients
treated with paclitaxel-coated balloons and paclitaxel-eluting stents
compared to patients treated with uncoated comparator devices. FDA
requests panel input regarding the presence and magnitude of the signal
and potential causes. FDA also seeks input regarding appropriate
regulatory actions associated with the findings.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person (see FOR FURTHER
INFORMATION CONTACT) on or before May 22, 2019. Oral presentations from
the public will be scheduled on June 19, 2019, between approximately 1
p.m. and 2 p.m.; and on June 20, 2019, between approximately 10:30 a.m.
and 11:30 a.m. Those individuals interested in making formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before May 14, 2019. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by May 15,
2019.
    Representatives from industry, professional organizations, and
societies interested in making formal presentations to the committee
should notify the contact person on or before May 22, 2019.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Artair Mallett at [email protected] or<PHONE_NUMBER> at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08033 Filed 4-19-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 159 (Friday, August 16, 2013)]
[Notices]
[Page 50135]
[FR Doc No: 2013-20104]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

CNC Development, Ltd., Exousia Advanced Materials, Inc., and
South American Minerals, Inc.; Order of Suspension of Trading

August 14, 2013.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
CNC Development, Ltd. because it has not filed any periodic reports
since the period ended December 31, 2010.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Exousia Advanced Materials, Inc. because it has not filed any periodic
reports since the period ended September 30, 2010.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
South American Minerals, Inc. because it has not filed any periodic
reports since it filed a Form 10-SB/A registration statement on January
19, 2005.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed companies is suspended for the period from 9:30 a.m. EDT
on August 14, 2013, through 11:59 p.m. EDT on August 27, 2013.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2013-20104 Filed 8-14-13; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 57 (Thursday, March 24, 2016)]
[Notices]
[Pages 15727-15728]
[FR Doc No: 2016-06710]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3662]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance on Reagents
for Detection of Specific Novel Influenza A Viruses

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April
25, 2016.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0584.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance on Reagents for Detection of Specific Novel Influenza A
Viruses--21 CFR Part 866 OMB Control Number 0910-0584--Extension

    In accordance with section 513 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA evaluated an
application for an in vitro diagnostic device for detection of
influenza subtype H5 (Asian lineage), commonly known as avian flu. FDA
concluded that this device is properly classified into class II in
accordance with section 513(a)(1)(B) of the FD&C Act, because it is a
device for which the general controls by themselves are insufficient to
provide reasonable assurance of the safety and effectiveness of the
device, but there is sufficient information to establish special
controls to provide such assurance. The statute permits FDA to
establish as special controls many different things, including
postmarket surveillance, development and dissemination of guidance
recommendations, and ``other appropriate actions as the Secretary deems
necessary'' (section 513(a)(1)(B) of the FD&C Act). This information
collection is a measure that FDA determined to be necessary to provide
reasonable assurance of safety and effectiveness of reagents for
detection of specific novel influenza A viruses.
    FDA issued an order classifying the H5 (Asian lineage) diagnostic
device into class II on March 22, 2006 (71 FR 14377), establishing the
special controls necessary to provide reasonable assurance of the
safety and effectiveness of that device and similar future devices. The
new classification was codified in 21 CFR 866.3332, a regulation that
describes the new classification for reagents for detection of specific
novel influenza A viruses and sets forth the special controls that help
to provide a reasonable assurance of the safety and effectiveness of
devices classified under that regulation. The regulation refers to the
special controls guidance document entitled ``Class II Special Controls
Guidance Document: Reagents for Detection of Specific Novel Influenza A
Viruses,'' which provides recommendations for measures to help provide
a reasonable assurance of safety and effectiveness for these reagents.
The guidance document recommends that sponsors obtain and analyze
postmarket data to ensure the continued reliability of their device in
detecting the specific novel influenza A virus that it is intended to
detect, particularly given the propensity for influenza viruses to
mutate and the potential for changes in disease prevalence over time.
As updated sequences for novel influenza A viruses become available
from the World Health Organization, National Institutes of Health, and
other public health entities, sponsors of reagents for detection of
specific novel influenza A viruses will collect this information,
compare them with the primer/probe sequences in their devices, and
incorporate the result of these analyses into their quality management
system, as required by 21 CFR 820.100(a)(1). These analyses will be
evaluated against the device design validation and risk analysis
required by 21 CFR 820.30(g) to determine if any design changes may be
necessary.
    FDA estimates that 10 respondents will be affected annually. Each
respondent will collect this information twice per year; each response
is estimated to take 15 hours. This results in a total data collection
burden of 300 hours.
    The guidance also refers to previously approved information
collections found in FDA regulations. The collections of information in
21 CFR part 801 have been approved under OMB control number 0910-0485;
the collections of information in 21 CFR part 807 subpart E have been
approved under OMB control number 0910-0120; and the collections of
information in 21 CFR

part 820 have been approved under OMB control number 0910-0073.
    In the Federal Register of October 19, 2015 (80 FR 63230), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                                Number of                      Average  burden
                          FD&C Act section                              Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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513(g).............................................................              10                2               20               15              300
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: March 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06710 Filed 3-23-16; 8:45 am]
 BILLING CODE 4164-01-P