[Federal Register Volume 88, Number 192 (Thursday, October 5, 2023)]
[Notices]
[Pages 69192-69205]
[FR Doc No: 2023-22188]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4182]

Revocation of Eleven Authorizations of Emergency Use of In Vitro
Diagnostic Device for Detection and/or Diagnosis of COVID-19;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to Luminostics, Inc., for the Clip COVID Rapid
Antigen Test; NeuMoDx Molecular, Inc., a QIAGEN Company, for the
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay; LGC, Biosearch
Technologies for the SARS-CoV-2 Real-Time and End-Point RT-PCR Test;
LGC, Biosearch Technologies, for the Biosearch Technologies SARS-CoV-2
ultra-high-throughput End-Point RT-PCR Test; Becton, Dickinson and Co.
for the BD Veritor At-Home COVID-19 Test; Verily Life Sciences for the
Verily COVID-19 RT-PCR Test; Clinical Research Sequencing Platform
(CRSP), LLC at the Broad Institute of MIT and Harvard for the CRSP
SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay
(Version 3); Xtrava Health for the SPERA COVID-19 Ag Test; Exact
Sciences Laboratories for the COVID-Flu Multiplex Assay; Exact Sciences
Laboratories for the SARS-CoV-2 (N gene detection) Test; and dba
SpectronRx for the Hymon SARS-CoV-2 Test Kit. FDA revoked these
Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) as requested by the Authorization holders. The revocations, which
include an explanation of the reasons for each revocation, are
reprinted in this document.

DATES: The Authorization for the Luminostics, Inc.'s, Clip COVID Rapid
Antigen Test is revoked as of May 5, 2023. The Authorization for the
NeuMoDx Molecular, Inc., a QIAGEN Company, for the NeuMoDx Flu A-B/RSV/
SARS-CoV-2 Vantage Assay is revoked as of May 24, 2023. The
Authorization for the LGC, Biosearch Technologies for the SARS-CoV-2
Real-

Time and End-Point RT-PCR Test is revoked as of June 1, 2023. The
Authorization for the LGC, Biosearch Technologies, for the Biosearch
Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test is
revoked as of June 1, 2023. The Authorization for the Becton, Dickinson
and Co.'s BD Veritor At-Home COVID-19 Test is revoked as of June 15,
2023. The Authorization for the Verily Life Sciences' Verily COVID-19
RT-PCR Test is revoked as of June 21, 2023. The Authorization for the
Clinical Research Sequencing Platform (CRSP), LLC at the Broad
Institute of MIT and Harvard for the CRSP SARS-CoV-2 Real-time Reverse
Transcriptase (RT)-PCR Diagnostic Assay (Version 3) is revoked as of
July 3, 2023. The Authorization for the Xtrava Health's SPERA COVID-19
Ag Test is revoked as of August 3, 2023. The Authorization for the
Exact Sciences Laboratories' COVID-Flu Multiplex Assay is revoked as of
August 18, 2023. The Authorization for the Exact Sciences Laboratories'
SARS-CoV-2 (N gene detection) Test is revoked as of August 18, 2023.
The Authorization for the dba SpectronRx's Hymon SARS-CoV-2 Test Kit is
revoked as of August 23, 2023.

ADDRESSES: Submit a written request for a single copy of the
revocations to the Office of Policy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request or include a Fax number to which the revocations may be sent.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
revocations.

FOR FURTHER INFORMATION CONTACT: Kim Sapsford-Medintz, Office of
Product Evaluation and Quality, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 3216, Silver Spring, MD 20993-0002,<PHONE_NUMBER> (this is not a
toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, radiological, or nuclear agent or agents. Among
other things, section 564 of the FD&C Act allows FDA to authorize the
use of an unapproved medical product or an unapproved use of an
approved medical product in certain situations. On December 7, 2020,
FDA issued the Authorization to Luminostics, Inc., for the for the Clip
COVID Rapid Antigen Test, subject to the terms of the Authorization.
Notice of the issuance of this Authorization was published in the
Federal Register on April 23, 2021 (86 FR 21749), as required by
section 564(h)(1) of the FD&C Act. On March 25, 2021, FDA issued the
Authorization to NeuMoDx Molecular, Inc., a QIAGEN Company, for the
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay, subject to the terms of
the Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on July 23, 2021 (86 FR 39040), as
required by section 564(h)(1) of the FD&C Act. On April 15, 2021, FDA
issued the Authorization to LGC, Biosearch Technologies for the SARS-
CoV-2 Real-Time and End-Point RT-PCR Test. Notice of the issuance of
this Authorization was published in the Federal Register on July 23,
2021 (86 FR 39040), subject to the terms of the Authorization. On
August 24, 2021, FDA issued the Authorization to Becton, Dickinson and
Co. for the BD Veritor At-Home COVID-19 Test, subject to the terms of
the Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on October 28, 2021 (86 FR 59740), as
required by section 564(h)(1) of the FD&C Act. On April 26, 2022, FDA
issued the Authorization to LGC, Biosearch Technologies, for the
Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-
PCR Test, subject to the terms of the Authorization. Notice of the
issuance of this Authorization was published in the Federal Register on
July 22, 2022 (87 FR 43877), as required by section 564(h)(1) of the
FD&C Act. On September 8, 2020, FDA issued the Authorization to Verily
Life Sciences for the Verily COVID-19 RT-PCR Test, subject to the terms
of the Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on November 20, 2020 (85 FR 74346),
as required by section 564(h)(1) of the FD&C Act. On March 5, 2021, FDA
issued the Authorization to Clinical Research Sequencing Platform
(CRSP), LLC at the Broad Institute of MIT and Harvard for the CRSP
SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay
(Version 3), subject to the terms of the Authorization. Notice of the
issuance of this Authorization was published in the Federal Register on
July 23, 2021 (86 FR 39040), as required by section 564(h)(1) of the
FD&C Act. On October 12, 2021, FDA issued the Authorization to Xtrava
Health for the SPERA COVID-19 Ag Test, subject to the terms of the
Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on March 22, 2022 (87 FR 16198), as
required by section 564(h)(1) of the FD&C Act. On July 1, 2021, FDA
issued the Authorization to Exact Sciences Laboratories for the COVID-
Flu Multiplex Assay, subject to the terms of the Authorization. Notice
of the issuance of this Authorization was published in the Federal
Register on October 28, 2021 (86 FR 59740), as required by section
564(h)(1) of the FD&C Act. On March 31, 2020, FDA issued the
Authorization to Exact Sciences Laboratories for the SARS-CoV-2 (N gene
detection) Test, subject to the terms of the Authorization. Notice of
the issuance of this Authorization was published in the Federal
Register on November 20, 2020 (85 FR 74346), as required by section
564(h)(1) of the FD&C Act. On May 22, 2020, FDA issued the
Authorization to dba SpectronRx for the Hymon SARS-CoV-2 Test Kit,
subject to the terms of the Authorization. Notice of the issuance of
this Authorization was published in the Federal Register on November
20, 2020 (85 FR 74346), as required by section 564(h)(1) of the FD&C
Act.
    Subsequent updates to the Authorizations were made available on
FDA's website. The authorization of a device for emergency use under
section 564 of the FD&C Act may, pursuant to section 564(g)(2) of the
FD&C Act, be revoked when the criteria under section 564(c) of the FD&C
Act for issuance of such authorization are no longer met (section
564(g)(2)(B) of the FD&C Act), or other circumstances make such
revocation appropriate to protect the public health or safety (section
564(g)(2)(C) of the FD&C Act).

II. Authorization Revocation Requests

    In a request received by FDA on May 2, 2023, Luminostics, Inc.
requested the withdrawal of, and on May 5, 2023, FDA revoked, the
Authorization for the Luminostics, Inc.'s Clip COVID Rapid Antigen
Test. Because Luminostics, Inc. notified FDA that there are no viable
Clip COVID Rapid Antigen Test reagents remaining in distribution in the
United States and requested FDA withdraw the Luminostics, Inc.'s Clip
COVID Rapid Antigen Test, FDA has determined that it is appropriate to
protect the public health or safety to revoke this Authorization.
    In a request received by FDA on May 11, 2023, NeuMoDx Molecular,
Inc., a QIAGEN Company requested revocation

of, and on May 24, 2023, FDA revoked, the Authorization for the NeuMoDx
Molecular, Inc., a QIAGEN Company's, NeuMoDx Flu A-B/RSV/SARS-CoV-2
Vantage Assay. Because NeuMoDx Molecular, Inc., a QIAGEN Company,
notified FDA that it has decided to discontinue distribution of the
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay in the United States and
requested FDA voluntary revocation of the EUA for the NeuMoDx Flu A-B/
RSV/SARS-CoV-2 Vantage Assay, FDA has determined that it is appropriate
to protect the public health or safety to revoke this Authorization.
    In a request received by FDA on May 1, 2023, LGC, Biosearch
Technologies requested revocation of, and on June 1, 2023, FDA revoked,
the Authorization for the LGC Biosearch Technologies' SARS-CoV-2 Real-
Time and End-Point RT-PCR Test. Because LGC, Biosearch Technologies
notified FDA that it is no longer marketing the SARS-CoV-2 Real-Time
and End-Point RT-PCR Test and requested FDA revoke the EUA for the LGC
Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test,
FDA has determined that it is appropriate to protect the public health
or safety to revoke this Authorization.
    In a request received by FDA on May 1, 2023, LGC, Biosearch
Technologies requested revocation of, and on June 1, 2023, FDA revoked,
the Authorization for the LGC Biosearch Technologies' SARS-CoV-2 ultra-
high-throughput End-Point RT-PCR Test. Because LGC, Biosearch
Technologies notified FDA that it is no longer marketing the SARS-CoV-2
ultra-high-throughput End-Point RT-PCR Test and requested FDA revoke
the EUA for the LGC Biosearch Technologies SARS-CoV-2 ultra-high-
throughput End-Point RT-PCR Test, FDA has determined that it is
appropriate to protect the public health or safety to revoke this
Authorization.
    In a request received by FDA on May 30, 2023, Becton, Dickinson and
Co. requested withdrawal of, and on June 15, 2023, FDA revoked, the
Authorization for the Becton, Dickinson and Co.'s BD Veritor At-Home
COVID-19 Test. Because Becton, Dickinson and Co. notified FDA that it
has discontinued the sale of BD Veritor At-Home COVID-19 Test and
requested FDA withdraw the EUA for the Becton, Dickinson and Co.'s BD
Veritor At-Home COVID-19 Test, FDA has determined that it is
appropriate to protect the public health or safety to revoke this
Authorization.
    In a request received by FDA on June 13, 2023, Verily Life Sciences
requested withdrawal of, and on June 21, 2023, FDA revoked, the
Authorization for the Verily Life Sciences' Verily COVID-19 RT-PCR
Test. Because Verily Life Sciences notified FDA that it is no longer
distributing the Verily COVID-19 Nasal Swab Kits (authorized as part of
the Verily COVID-19 RT-PCR Test) or offering testing services at the
Verily Life Sciences' laboratory using the Verily COVID-19 RT-PCR Test
and requested FDA withdraw the EUA for the Verily Life Sciences' Verily
COVID-19 RT-PCR Test, FDA has determined that it is appropriate to
protect the public health or safety to revoke this Authorization.
    In a request received by FDA on June 14, 2023, Clinical Research
Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and
Harvard, requested voluntary revocation of, and on July 3, 2023, FDA
revoked, the Authorization for the CRSP, LLC at the Broad Institute of
MIT and Harvard's CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-
PCR Diagnostic Assay (Version 3). Because CRSP, LLC at the Broad
Institute of MIT and Harvard notified FDA that it is no longer
distributing the CRSP Self-swab Kits (authorized as part of the CRSP
SARS-CoV-2 Real-time RT-PCR Diagnostic Assay (Version 3)) or offering
testing services at the CRSP, LLC at the Broad Institute of MIT and
Harvard laboratory using the CRSP SARS-CoV-2 Real-time RT-PCR
Diagnostic Assay (Version 3), and requested FDA revoke the EUA for the
CRSP, LLC at the Broad Institute of MIT and Harvard's CRSP SARS-CoV-2
Real-time RT-PCR Diagnostic Assay (Version 3), FDA has determined that
it is appropriate to protect the public health or safety to revoke this
Authorization.
    In a request received by FDA on July 18, 2023, Xtrava Health
requested the withdrawal of, and on August 3, 2023, FDA revoked, the
Authorization for the Xtrava Health's SPERA COVID-19 Ag Test. Because
Xtrava Health notified FDA that there are no SPERA COVID-19 Ag Test
reagents in distribution in the United States and requested FDA
withdraw the Xtrava Health's, SPERA COVID-19 Ag Test, FDA has
determined that it is appropriate to protect the public health or
safety to revoke this Authorization.
    In a request received by FDA on August 1, 2023, Exact Sciences
Laboratories requested the withdrawal of, and on August 18, 2023, FDA
revoked, the Authorization for the Exact Sciences Laboratories' COVID-
Flu Multiplex Assay. Because Exact Sciences Laboratories notified FDA
that they have discontinued use of the COVID-Flu Multiplex Assay at
Exact Sciences Laboratories and requested FDA withdraw the Exact
Sciences Laboratories' COVID-Flu Multiplex Assay, FDA has determined
that it is appropriate to protect the public health or safety to revoke
this Authorization.
    In a request received by FDA on August 1, 2023, Exact Sciences
Laboratories requested the withdrawal of, and on August 18, 2023, FDA
revoked, the Authorization for the Exact Sciences Laboratories' SARS-
CoV-2 (N gene detection) Test. Because Exact Sciences Laboratories
notified FDA that they have discontinued use of the SARS-CoV-2 (N gene
detection) Test at Exact Sciences Laboratories and requested FDA
withdraw the Exact Sciences Laboratories' SARS-CoV-2 (N gene detection)
Test, FDA has determined that it is appropriate to protect the public
health or safety to revoke this Authorization.
    In a request received by FDA on March 24, 2023, dba SpectronRx
requested the withdrawal of, and on August 23, 2023, FDA revoked, the
Authorization for the dba SpectronRx's Hymon SARS-CoV-2 Test Kit.
Because dba SpectronRx notified FDA that they are discontinuing the
distribution of the Hymon SARS-CoV-2 Test Kit and requested FDA
withdraw the dba SpectronRx for the Hymon SARS-CoV-2 Test Kit, FDA has
determined that it is appropriate to protect the public health or
safety to revoke this Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
revocations are available on the internet at https://www.regulations.gov/.

IV. The Revocations

    Having concluded that the criteria for revocation of the
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUA of Luminostics, Inc.'s, Clip COVID Rapid Antigen
Test, NeuMoDx Molecular, Inc., a QIAGEN Company's, NeuMoDx Flu A-B/RSV/
SARS-CoV-2 Vantage Assay, LGC Biosearch Technologies' SARS-CoV-2 Real-
Time and End-Point RT-PCR Test, LGC Biosearch Technologies' SARS-CoV-2
ultra-high-throughput End-Point RT-PCR Test, Becton, Dickinson and
Co.'s BD Veritor At-Home COVID-19 Test, Verily Life Sciences' Verily
COVID-19 RT-PCR Test, Clinical Research Sequencing Platform (CRSP), LLC
at the Broad Institute of MIT and Harvard's CRSP SARS-CoV-2 Real-time
Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3), Xtrava
Health's SPERA COVID-19 Ag Test, Exact Sciences Laboratories' COVID-Flu
Multiplex Assay, Exact Sciences

Laboratories' SARS-CoV-2 (N gene detection) Test, and dba SpectronRx's
Hymon SARS-CoV-2 Test Kit. These revocations in their entirety follow
and provide an explanation of the reasons for each revocation, as
required by section 564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P
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    Dated: October 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22188 Filed 10-4-23; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 86, Number 239 (Thursday, December 16, 2021)]
[Notices]
[Page 71516]
[FR Doc No: 2021-27205]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4625-DR; Docket ID FEMA-2021-0001]

New York; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of New York (FEMA-4625-DR), dated October 8, 2021, and
related determinations.

DATES: This amendment was issued November 5, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of New York is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of October 8, 2021.

    Onondaga County for Public Assistance.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-27205 Filed 12-15-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 109 (Friday, June 6, 2014)]
[Notices]
[Pages 32817-32818]
[FR Doc No: 2014-13184]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2013-0145; Notice 1]

KBC America, Inc., Receipt of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of Petition.

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SUMMARY: KBC America, Inc. ``KBCA'' has determined that certain
motorcycle helmets manufactured by KBC Corporation for Harley-Davidson
as Harley-Davidson brand helmets do not fully comply with paragraph S4
of Federal Motor Vehicle Safety Standard (FMVSS) No. 218, Motorcycle
Helmets. KBCA has filed an appropriate report dated December 12, 2013,
pursuant to 49 CFR part 573, Defect and Noncompliance Responsibility
and Reports.

DATES: The closing date for comments on the petition is July 7, 2014.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited at the beginning of this notice and be
submitted by any of the following methods:
     Mail: Send comments by mail addressed to: U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
     Hand Deliver: Deliver comments by hand to: U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The
Docket Section is open on weekdays from 10 a.m. to 5 p.m. except
Federal Holidays.
     Electronically: Submit comments electronically by: Logging
onto the Federal Docket Management System (FDMS) Web site at http://www.regulations.gov/. Follow the online instructions for submitting
comments. Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that your comments were received, please
enclose a stamped, self-addressed postcard with the comments. Note that
all comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
    Documents submitted to a docket may be viewed by anyone at the
address and times given above. The documents may also be viewed on the
Internet at http://www.regulations.gov by following the online
instructions for accessing the dockets. DOT's complete Privacy Act
Statement is available for review in the Federal Register published on
April 11, 2000, (65 FR 19477-78).
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated below will
be filed and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the extent possible. When the petition is granted or
denied, notice of the decision will be published in the Federal
Register pursuant to the authority indicated below.

SUPPLEMENTARY INFORMATION:

I. KBCA's Petition

    Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule
at 49 CFR part 556), KBCA submitted a petition for an exemption from
the notification and remedy requirements of 49 U.S.C. Chapter 301 on
the basis that this noncompliance is inconsequential to motor vehicle
safety.
    This notice of receipt of KBCA's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.

II. Helmets Involved

    Affected are approximately 566 Jet model helmets that KBC
Corporation manufactured in December 2012 for Harley Davidson, who in
turn marketed these helmets under its own brand by the model name
``Black Label Retro \3/4\.''

III. Noncompliance

    KBCA explains that the subject helmets fail to fully comply with
the requirements of S5.6.1(e) of FMVSS No. 218 that was in effect on
the date of manufacture of these helmets because the goggle strap
holders on the rear of the helmets obscure the DOT certification label
from view.

IV. Rule Text

    Paragraph S5.6.1(e) of FMVSS No. 218 requires in pertinent part:

    S5.6.1 Each helmet shall be labeled permanently and legibly, in
a manner such that the label(s) can be read easily without removing
padding or any other permanent part, with the following: * * *
    (e) The symbol DOT, constituting the manufacturer's
certification that the helmet conforms to the applicable Federal
motor vehicle safety standards. This symbol shall appear on the
outer surface, in a color that contrasts with the background, in
letters at least 3/8 inch (1 cm) high, centered laterally with the
horizontal centerline of the symbol located a minimum of 1 1/8
inches (2.9 cm) and a maximum of 1 3/8 inches (3.5 cm) from the
bottom edge of the posterior portion of the helmet.

V. Summary of KBCA's Analyses

    KBCA stated its belief that the subject noncompliance is
inconsequential to motor vehicle safety for the following reasons:
    1. KBCA believes that the subject helmets comply with the
performance requirements of FMVSS No. 218 and that neither the presence
of the strap holder nor the fact that it can obscure the DOT label
affects the helmet's ability to protect the wearer in the event of a
crash.
    2. KBCA states that other than the subject noncompliance the DOT
label on the subject helmets comply with the requirements of FMVSS No.
218.
    3. KBCA also believes that while the DOT label is not visible when
the strap holder is fastened, a user can easily view the label by
unfastening the strap holder to confirm that the helmet has been
certified and thus complies with the requirements set forth in FMVSS
No. 218.
    4. KBCA further believes that if their company were required to do
a recall of the subject helmets, it would be likely that a very low
percentage of helmets would be returned, if any, and that in doing so
would leave the owners without a helmet while the subject helmets are
retrofitted with a new label.
    5. KBCA expressed its belief that in similar situations NHTSA has
granted petitions for inconsequential noncompliance regarding other
products that have incorrect or missing label information required by
other FMVSS's.
    KBCA has additionally informed NHTSA that it no longer manufactures
the subject helmets.
    In summation, KBCA believes that the described noncompliance of the
subject helmets is inconsequential to motor vehicle safety, and that
its petition, to exempt KBCA from providing recall notification of
noncompliance as required by 49 U.S.C. 30118 and remedying the recall
noncompliance as required by 49 U.S.C. 30120 should be granted.

    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject helmets that KBCA no longer
controlled at the time it determined that the noncompliance existed.
However, any decision on this petition does not relieve distributors
and dealers of the prohibitions on the sale, offer for sale, or
introduction or delivery for introduction into interstate commerce of
the noncompliant helmets under their control after KBCA notified them
that the subject noncompliance existed.

    Authority:  (49 U.S.C. 30118, 30120: Delegations of authority at
49 CFR 1.95 and 501.8)

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2014-13184 Filed 6-5-14; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: April 6, 2007 (Volume 72, Number 66)]
[Rules and Regulations]
[Page 17025-17027]
[DOCID:fr06ap07-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R01-OAR-2007-0136; A-1-FRL-8295-6]

Approval and Promulgation of State Plans for Designated
Pollutants and Facilities; Rhode Island; Negative Declaration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is approving a Section 111(d) and 129 negative declaration
submitted by the State of Rhode Island on November 5, 2006. This
negative declaration adequately certifies that there are no existing
``other solid waste incineration'' (OSWI) units located within the
boundaries of the State of Rhode Island. This action is being taken in
accordance with the Clean Air Act.

DATES: This direct final rule will be effective June 5, 2007, unless
EPA receives adverse comments by May 7, 2007. If adverse comments are
received, EPA will publish a timely withdrawal of the direct final rule
in the Federal Register informing the public that the rule will not
take effect.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R01-OAR-2007-0136 by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``Docket Identification Number EPA-R01-OAR-2007-0136, Dan
Brown, Chief, Air Permits, Toxics, and Indoor Air Unit, Office of
Ecosystem Protection, U.S. Environmental Protection Agency, EPA New
England Regional Office, One Congress Street, Suite 1100 (mail code
CAP), Boston, MA 02114-2023.
    5. Hand Delivery or Courier. Deliver your comments to: Dan Brown,
Chief, Air Permits, Toxics, and Indoor Air Unit, Office of Ecosystem
Protection, U.S. Environmental Protection Agency, EPA New England
Regional Office, One Congress Street, 11th floor, (CAP), Boston, MA
02114-2023. Such deliveries are only accepted during the Regional
Office's normal hours of operation. The Regional Office's official
hours of business are Monday through Friday, 8:30 to 4:30 excluding
legal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R01-OAR-
2007-0136. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit through http://www.regulations.gov
, or e-mail, information that you consider to be CBI

or otherwise protected. The http://www.regulations.gov website is an

``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov
 or in hard copy at Office of Ecosystem Protection,

U.S. Environmental Protection Agency, EPA New England Regional Office,
One Congress Street, Suite 1100, Boston, MA. EPA requests that if at
all possible, you contact the contact listed in the FOR FURTHER
INFORMATION CONTACT section to schedule your inspection. The Regional
Office's official hours of business are Monday through Friday, 8:30 to
4:30 excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Ian D. Cohen, Air Permits, Toxics, and
Indoor Air Programs, U.S. Environmental Protection Agency, EPA New
England Regional Office, One Congress Street (CAP), Boston, MA 02114-
2023, telephone number<PHONE_NUMBER>, fax number<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

How Can I Get Copies of This Document and Other Related Information?

    In addition to the publicly available docket materials available
for inspection electronically in the Federal Docket Management System
at http://www.regulations.gov, and the hard copy available at the

Regional Office, which are identified in the ADDRESSES section of this
Federal Register, copies of the state submittal are also available for
public inspection during normal business hours, by appointment at the
State Air Agency: Office of Air Resources, Department of Environmental
Management, 235 Promenade Street, Providence, RI 02908-5767.

II. Rulemaking Information

    Organization of this document. The following outline is provided to
aid in locating information in this preamble.

A. Background and Purpose
B. When did the Requirements first Become Known?
C. What is the definition of an OSWI?
D. When did Rhode Island submit its negative declaration?

A. Background and Purpose

    Section 129 of the Clean Air Act requires EPA to publish rules
regulating emissions from several classes of solid waste incinerators.
Under Section 111(d) of the Clean Air Act, EPA published regulations at
40 CFR Part 60 Subpart B which require states to submit plans to
control emissions of specific pollutants from designated facilities. As
federal rules covering each category of solid waste incinerator are
promulgated, a State must either submit a plan or accept delegation of
a federal plan. If a state does not have a designated facility within
its boundaries, the state may submit a negative declaration in lieu of
a control plan.

B. When did the requirements first become known?

    On December 9, 2004, EPA proposed emissions guidelines for other
solid waste incinerators (OSWI) units. This action enabled EPA to list
OSWI units as designated facilities. By proposing these guidelines, EPA
specified particulate matter, opacity, sulfur dioxide, hydrogen
chloride, oxides of nitrogen, carbon monoxide, lead, cadmium, mercury,
and dioxins/furans as designated pollutants. These guidelines were
published as a final rule on December 16, 2005 (70 FR 74870) and
codified at 40 CFR 60, subpart EEEE.

C. What is the definition of an OSWI?

    Forty CFR 60.2977 defines an OSWI as either a very small municipal
waste combustion unit or an institutional waste unit. A very small
municipal waste unit is a unit which combusts less than 35 tons per day
of municipal solid waste or refuse derived fuel. An institutional waste
unit is a unit which serves an organization having a governmental,
educational, civic, or religious purpose. Units which meet certain
criteria are not affected by this subpart. These criteria are listed in
40 CFR 60.2887.

D. When did Rhode Island submit its negative declaration?

    On November 8, 2006, the Rhode Island Department of Environmental
Management (RI DEM) submitted a letter certifying that there are no
existing OSWI units subject to 40 CFR Part 60 Subpart B. Section 111(d)
of the Clean Air Act and 40 CRF 62.06 says that when no such designated
facilities exist within a state's boundaries, the affected state may
submit a letter of ``negative declaration'' instead of a control plan.
Today's action amends 40 CFR Part 62 to include this negative
declaration.

III. Final Action

    EPA is approving the negative declaration of air emissions from
OSWI submitted by the State of Rhode Island.
    The EPA is publishing this action without prior proposal because
the Agency views this as a noncontroversial amendment and anticipates
no adverse comments. However, in the proposed rules section of this
Federal Register publication, EPA is publishing a separate document
that will serve as the proposal to approve the SIP revision should
relevant adverse comments be filed. This rule will be effective June 5,
2007 without further notice unless the Agency receives relevant adverse
comments by May 7, 2007.
    If the EPA receives such comments, then EPA will publish a notice
withdrawing the final rule and informing the public that the rule will
not take effect. All public comments received will then be addressed in
a subsequent final rule based on the proposed rule. The EPA will not
institute a second comment period on the proposed rule. All parties
interested in commenting on the proposed rule should do so at this
time. If no such comments are received, the public is advised that this
rule will be effective on June 5, 2007 and no further action will be
taken on the proposed rule. Please note that if EPA receives adverse
comment on an amendment, paragraph, or section of this rule and if that
provision may be severed from the remainder of the rule, EPA may adopt
as final those provisions of the rule that are not the subject of an
adverse comment.

 IV. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999), because it merely approves a state rule
implementing a federal standard, and does not alter the relationship or
the distribution of power and responsibilities established in the Clean
Air Act. This rule also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it approves a state
action implementing a federal standard.
    In reviewing Section 111(d) submissions, EPA's role is to approve
state choices, provided that they meet the criteria of the Clean Air
Act. In this context, in the absence of a prior existing requirement
for the State to use voluntary consensus standards (VCS), EPA has no
authority to disapprove a state action for failure to use VCS. It would
thus be inconsistent with applicable law for EPA, when it reviews a
state plan, to use VCS in place of a state plan that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. section 801 et seq., as
added by the Small Business Regulatory Enforcement Fairness Act of
1996, generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of the rule in the Federal Register. A major rule
cannot take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
section 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by June 5, 2007. Interested
parties should comment in response to the proposed rule rather than
petition for judicial review, unless

the objection arises after the comment period allowed for in the
proposal. Filing a petition for reconsideration by the Administrator of
this final rule does not affect the finality of this rule for the
purposes of judicial review nor does it extend the time within which a
petition for judicial review may be filed, and shall not postpone the
effectiveness of such rule or action. This action may not be challenged
later in proceedings to enforce its requirements. (See section
307(b)(2).)

List of Subjects in 40 CFR Part 62

    Environmental protection, Administrative practices and procedures,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements, Solid Waste Incinerators, Waste treatment
and disposal.

    Dated: March 27, 2007.
Robert W. Varney,
Regional Administrator, EPA New England.

0
40 CFR part 62 is amended as follows:

PART 62--[AMENDED]

0
1. The authority citation for part 62 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart OO--Rhode Island

0
2. Subpart OO is amended by adding a new Sec.  62.9995 and a new
undesignated center heading to read as follows:

Air Emissions From Existing Other Solid Waste Incineration Units

Sec.  62. 9995  Identification of Plan-Negative Declaration.

    On November 5, 2006, the Rhode Island Department of Environmental
Management submitted a letter certifying that there are no existing
other solid waste incineration units in the state subject to the
emission guidelines under part 60, subpart EEEE of this chapter.

[FR Doc. E7-6460 Filed 4-5-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 81 (Thursday, April 26, 2018)]
[Notices]
[Pages 18384-18385]
[FR Doc No: 2018-08732]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83083; File No. SR-GEMX-2018-13]

Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Incorporate by
Reference The Nasdaq Stock Market LLC's Consolidated Audit Trail Rules
Into the Rules of Nasdaq GEMX

April 20, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 10, 2018, Nasdaq GEMX, LLC (``GEMX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to incorporate by reference The Nasdaq Stock
Market LLC's (``Nasdaq'') rule at General 7, entitled ``Consolidated
Audit Trail Compliance'' into GEMX's General 7.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqgemx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to incorporate by reference Nasdaq's rule at
General 7, entitled ``Consolidated Audit Trail Compliance'' into GEMX's
General 7. The rule sets are identical.\3\ GEMX proposes to remove the
current rule text from General 7 and replace that rule text with the
following text: \4\
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    \3\ See Securities Exchange Act Release Nos. 82601 (January 30,
2018), 83 FR 4949 (February 2, 2018) (SR-Phlx-2018-11); 82604
(January 30, 2018), 83 FR 5154 (February 5, 2018) (SR-NASDAQ-2018-
007); 82597 (January 30, 2018), 83 FR 4942 (February 2, 2018) (SR-
BX-2018-007); 82599 (January 30, 2017), 83 FR 4947 (February 2,
2018) (SR-ISE-2018-09); 82598 (January 30, 2018), 83 FR 4936
(February 2, 2018) (SR-GEMX-2018-02); and 82600 (January 30, 2018),
83 FR 4934 (February 2, 2018) (SR-MRX-2018-03).
    \4\ GEMX shall include a hyperlink to Nasdaq's General 7 for
ease of reference.
---------------------------------------------------------------------------

    The rules contained in The Nasdaq Stock Market LLC General 7, as
such rules may be in effect from time to time (the ``General 7
Rules''), are hereby incorporated by reference into this Nasdaq GEMX
General 7, and are thus Nasdaq GEMX Rules and thereby applicable to
Nasdaq GEMX Members. Nasdaq GEMX Members shall comply with the General
7 Rules as though such rules were fully set forth herein. All defined
terms, including any variations thereof, contained in the General 7
Rules shall be read to refer to the Nasdaq GEMX related meaning of such
term. Solely by way of example, and not in limitation or in exhaustion:
the defined term ``Exchange'' in the General 7 Rules shall be read to
refer to the Nasdaq GEMX Exchange; the defined term ``Rule'' in the
General 7 Rules shall be read to refer to the Nasdaq GEMX Rule.
    Should any rules which impact trading behavior be added to the
Consolidated Audit Trail Compliance Rules in Nasdaq General 7 in the
future, those rules shall not become subject to the incorporation by
reference and shall be placed elsewhere within GEMX's Rulebook. The
incorporations by reference of Nasdaq General 7 into GEMX's General 7
Rule are regulatory in nature.\5\ The Exchange notes that as a
condition of an exemption, which the Exchange will request and will
need to be approved by the Commission,\6\ GEMX agrees to provide
written notice to its members whenever Nasdaq proposes a change to its
General 7 Rule.\7\ Such notice will alert GEMX members to the proposed
Nasdaq rule change and give them an opportunity to comment on the
proposal. GEMX will similarly inform its members in writing when the
SEC approves any such proposed change.
---------------------------------------------------------------------------

    \5\ The General 7 Rules are categories of rules that are not
trading rules. See 17 CFR 200.30-3(a)(76) (contemplating such
requests). In addition, several other SROs incorporate by reference
certain regulatory rules of another SRO and have received from the
Commission similar exemptions from Section 19(b) of the Exchange
Act. See e.g., Securities Exchange Act Release Nos. 57478 (March 12,
2008), 73 FR 14521 (March 18, 2008), 53128 (January 13, 2006), 71 FR
3550 (January 23, 2006); 49260 (February 17, 2004), 69 FR 8500
(February 24, 2004).
    \6\ The Exchange will request an exemption pursuant to its
authority under Section 36 of the Exchange Act of 1934 (``Act'') and
Rule 0-121 thereunder, from the Section 19(b) rule filing
requirements to separately file a proposed rule change to amend GEMX
General 7.
    \7\ GEMX will provide such notice via a posting on the same
website location where GEMX posts its own rule filings pursuant to
Rule 19b-4 within the timeframe require by such Rule. The website
posting will include a link to the location on the Nasdaq website
where the applicable proposed rule change is posted.
---------------------------------------------------------------------------

Implementation
    The Exchange proposes that this rule change become operative at
such time as it receives approval for an exemption from the Securities
and Exchange Commission, pursuant to its authority under Section 36 of
the Exchange Act of 1934 (``Act'') and Rule 0-12 \8\ thereunder, from
the Section 19(b) rule filing requirements to separately file a
proposed rule change to amend GEMX General 7.
---------------------------------------------------------------------------

    \8\ See 17 CFR 240.0-12; Exchange Act Release No. 39624
(February 5, 1998), 63 FR 8101 (February 18, 1998).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\9\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\10\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest, by consolidating its rules into a single rule set. The
Exchange intends to also file similar proposed rule changes for the
Nasdaq PHLX LLC; Nasdaq GEMX, LLC; Nasdaq ISE, LLC; and Nasdaq MRX, LLC
markets so that the General 7 Rules

which govern Consolidated Audit Trail Compliance are conformed.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Incorporating by reference the Nasdaq General 7 Rules into the GEMX
General 7 Rules will provide an easy reference for Members seeking to
comply with Consolidated Audit Trail on multiple markets. As noted, the
Exchange intends to file similar proposed rule changes for other
affiliated markets so that Nasdaq General 7 is the source document for
all Nasdaq Consolidated Audit Trail rules. The Exchange notes that the
current rule is not changing and GEMX members will be required to
continue to comply with the General 7 Rules as though such rules are
fully set forth in GEMX's Rulebook. The Exchange desires to conform its
rules and locate those rules within the same location in each Rulebook
to provide Members the ability to quickly locate rules.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange believes that this
rule change does not impose an undue burden on competition because GEMX
is merely incorporating by reference the rules of Nasdaq's General 7
into its own Rulebook. The current General 7 is not being amended and
therefore no Member is impacted.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \11\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \12\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-GEMX-2018-13 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-GEMX-2018-13. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-GEMX-2018-13 and should be submitted on
or before May 17, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-08732 Filed 4-25-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Notices]
[Page 31935]
[FR Doc No: 2014-12716]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP14-995-000.
    Applicants: ANR Pipeline Company.
    Description: Wisconsin P&L FTS Agmt to be effective 6/1/2014.
    Filed Date: 5/27/14.
    Accession Number: 20140527-5030.
    Comments Due: 5 p.m. ET 6/9/14.

    Docket Numbers: RP14-536-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Refund Report to be effective N/A.
    Filed Date: 5/23/14.
    Accession Number: 20140523-5175.
    Comments Due: 5 p.m. ET 6/4/14.

    Docket Numbers: RP14-995-000.
    Applicants: ANR Pipeline Company.
    Description: ANR Pipeline Company submits tariff filing per
154.601: Wisconsin P&L FTS Agmt to be effective 6/1/2014.
    Filed Date: 5/27/14.
    Accession Number: 20140527-5030.
    Comments Due: 5 p.m. ET 6/9/14.

    Docket Numbers: RP14-996-000.
    Applicants: Columbia Gulf Transmission, LLC.
    Description: ELEOP Retainage Filing to be effective 5/1/2011.
    Filed Date: 5/27/14.
    Accession Number: 20140527-5055.
    Comments Due: 5 p.m. ET 6/9/14.

    Docket Numbers: RP14-997-000.
    Applicants: East Tennessee Natural Gas, LLC.
    Description: Wacker Negotiated Rates to be effective 7/1/2014.
    Filed Date: 5/27/14.
    Accession Number: 20140527-5057.
    Comments Due: 5 p.m. ET 6/9/14.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP14-872-001.
    Applicants: Granite State Gas Transmission, Inc.
    Description: Amendment to Capacity Release Filing 21 to be
effective 7/1/2014.
    Filed Date: 5/23/14.
    Accession Number: 20140523-5144.
    Comments Due: 5 p.m. ET 6/4/14.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: May 27, 2014.
 Nathaniel J. Davis, Sr.,
 Deputy Secretary.
[FR Doc. 2014-12716 Filed 6-2-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 227 (Friday, November 25, 2016)]
[Proposed Rules]
[Pages 85201-85203]
[FR Doc No: 2016-28359]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2016-0968]
RIN 1625-AA09

Drawbridge Operation Regulation; Youngs Bay, Astoria, OR

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to change the operating schedule that
governs the Oregon State highway bridge across Youngs Bay foot of Fifth
Street (Old Youngs Bay Bridge), mile 2.4, at Astoria, OR. The Oregon
Department of Transportation (ODOT) is proposing to change the
operating schedule of the Old Youngs Bay Bridge for several months
while work is performed on the north bascule lift. This change would
allow ODOT to operate the double bascule draw in single leaf mode, one
lift at a time, and reduce the vertical clearance of the non-operable
half of the span by five feet.

DATES: Comments and related material must reach the Coast Guard on or
before December 27, 2016. The Coast Guard anticipates that this
proposed rule will be effective from 7 a.m. on March 1, 2017 to 5 p.m.
on October 31, 2017.

ADDRESSES: You may submit comments identified by docket number USCG-
2016-0968 using Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section below for
instructions on submitting comments.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Steven M. Fischer, Bridge Administrator, Thirteenth
Coast Guard District Bridge Program Office, telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section
U.S.C. United States Code
ODOT Oregon State Department of Transportation

II. Background, Purpose and Legal Basis

    ODOT owns and operates the Old Youngs Bay Bridge, and proposes a
temporary change to the existing operating regulation. The Coast Guard
approved a temporary rule change authorizing ODOT to operate the Old
Youngs Bay Bridge in single leaf mode from May 2016 through October
2016, document citation 81 FR 28018. No negative impacts were observed
during that rule change. The subject proposed regulation will allow the
drawtender to open half the draw span in single leaf mode, from 7 a.m.
on March 1, 2017 to 5 p.m. on October 31, 2017. ODOT's proposal would
allow the construction workers to utilize a containment system that
reduces the non-opening half of the bridge's vertical clearance by five
feet. Marine traffic on Youngs Bay consists of vessels ranging from
small pleasure craft, sailboats, small tribal fishing boats, and
commercial tug and tow, and mega yachts.

III. Discussion of Proposed Rule

    This proposed rule would temporarily amend 33 CFR 117.899 by adding
the south lift only to open in single leaf

mode, and suspend a full opening. This proposed rule is necessary to
accommodate extensive maintenance and restoration efforts on the Old
Youngs Bay Bridge. This bridge provides a vertical clearance
approximately 19 feet above mean high water when in the closed-to-
navigation position. One half of the double bascule bridge will have a
containment system installed on the north half of the span, which will
reduce the vertical clearance by 5 feet from 19 feet above mean high
water to 14 feet above mean high water. Adjusting the existing
drawbridge regulation will allow construction workers to complete
bridge and highway upgrades before winter of 2017, while having minimal
impact on maritime navigation, and no alternate routes are on this part
of Youngs Bay into Youngs River.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive order (s) related to rulemaking. Below we summarize our
analyses based on these statutes and Executive order (s), and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    E.O. 12866 and E.O. 13563 direct agencies to assess the costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits.
E.O. 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This NPRM has not been designated a ``significant
regulatory action,'' under Executive order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget. This
regulatory action determination is based on the ability for the Old
Youngs Bay Bridge to open half the span on signal, and not delay
passage of any mariner. Vessels not requiring an opening may pass under
the bridge at any time. The north lift vertical clearance will be
reduced as explained in paragraph III. No alternate routes are
available on this part of Youngs Bay.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities. While some owners or operators of
vessels intending to transit the bridge may be small entities, for the
reasons stated in section IV.A above, this proposed rule would not have
a significant economic impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION
CONTACT, above. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

D. Federalism and Indian Tribal Government

    A rule has implications for federalism under E.O. 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive order
13132.
    Also, this proposed rule does not have tribal implications under
Executive order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such expenditure, we do discuss the effects of this proposed
rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions which do not individually or cumulatively have a
significant effect on the human environment. This proposed rule simply
promulgates the operating regulations or procedures for drawbridges.
Normally such actions are categorically excluded from further review,
under figure 2-1, paragraph (32) (e), of the Instruction.
    Under figure 2-1, paragraph (32) (e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and

will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this notice and all public comments, are in
our online docket at http://www.regulations.gov and can be viewed by
following that Web site's instructions. Additionally, if you go to the
online docket and sign up for email alerts, you will be notified when
comments are posted or a final rule is published.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. In Sec.  117.899, from 7 a.m. on March 1, 2017 through 5 p.m. on
October 31, 2017, suspend paragraph (b) and add paragraph (d) to read
as follows:

Sec.  117.899  Drawbridge Operation Regulation; Youngs Bay, Astoria, OR

* * * * *
    (d) The draw of the Oregon State (Old Youngs Bay) Highway Bridge,
mile 2.4, across Youngs Bay foot of Fifth Street, shall open the south
half of the double bascule span on signal for the passage of vessels,
if at least one half-hour notice is given to the drawtender, at the
Lewis and Clark River Bridge by marine radio, telephone, or other
suitable means from 7 a.m. to 5 p.m. Monday through Friday and from 8
a.m. to 4 p.m. Saturday and Sunday from March 1, 2017 to October 31,
2017. At all other times, including all Federal holidays, but Columbus
Day, at least a two-hour notice by telephone is required. The opening
signal is two prolonged blasts followed by one short blast.

    Dated: November 16, 2016.
Brendan McPherson,
Captain, U.S. Coast Guard, Acting Commander, Thirteenth Coast Guard
District.
[FR Doc. 2016-28359 Filed 11-23-16; 8:45 am]
BILLING CODE 9110-04-P