[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15779-15780]
[FR Doc No: 2012-6390]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-M-0735, FDA-2011-M-0736, FDA-2011-M-0737, FDA-
2011-M-0746, FDA-2011-M-0786, FDA-2011-M-0791, FDA-2011-M-0792, FDA-
2011-M-0796, FDA-2011-M-0832, FDA-2011-M-0837, FDA-2011-M-0848, FDA-
2011-M-0865, FDA-2011-M-0866, FDA-2011-M-0910, and FDA-2011-M-0917]

Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
Agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in table
1 of this document when submitting a written request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the FD&C Act. The
30-day period for requesting reconsideration of an FDA action under
Sec.  10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a
PMA begins on the day the notice is placed on the Internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
    The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from October 1, 2011, through December 31,
2011. There were no denial actions during this period. The list
provides the manufacturer's name, the product's generic name or the
trade name, and the approval date.

   Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From October 1, 2011,
                                            Through December 31, 2011
----------------------------------------------------------------------------------------------------------------
        PMA No., Docket No.               Applicant             Trade name                Approval date
----------------------------------------------------------------------------------------------------------------
P110003, FDA-2011-M-0746..........  Pluromed, Inc........  LEGOO...............  September 28, 2011.
P090024, FDA-2011-M-0737..........  Siemens Healthcare     ADVIA CENTAUR HBEAG   October 11, 2011.
                                     Diagnostics.           assay and quality
                                                            control material.
P040024 (S51), FDA-2011-M-0735....  Medicis Aesthetics,    RESTYLANE injectable  October 11, 2011.
                                     Inc.                   gel.
P010029 (S8), FDA-2011-M-0736.....  Ferring                EUFLEXXA (1% sodium   October 11, 2011.
                                     Pharmaceuticals, Inc.  hyaluronate).
P110022, FDA-2011-M-0786..........  Roche Diagnostics      ELECSYS anti-HBC IGM  October 26, 2011.
                                     Corp.                  immunoassay and
                                                            ELECSYS
                                                            PRECICONTROL anti-
                                                            HBC IGM.
P110011, FDA-2011-M-0791..........  Medtronic Ireland....  ASSURANT COBALT       October 26, 2011.
                                                            iliac balloon-
                                                            expandable stent
                                                            system.
P100042, FDA-2011-M-0792..........  Gen-Probe              APTIMA HPV assay....  October 28, 2011.
                                     Incorporated.
P110019, FDA-2011-M-0796..........  Abbott Vascular......  XIENCE PRIME and      November 1, 2011.
                                                            XIENCE PRIME LL
                                                            EVEROLIMUS-eluting
                                                            coronary stent
                                                            system.
P100041, FDA-2011-M-0837..........  Edwards Lifesciences,  EDWARDS SAPIEN        November 2, 2011.
                                     LLC.                   transcatheter heart
                                                            valve and RETROFLEX
                                                            3 delivery system,
                                                            RETROFLEX balloon
                                                            catheter and
                                                            crimper.
P090016, FDA-2011-M-0832..........  Merz Aesthetics, Inc.  BELOTERO balance....  November 14, 2011.
H090002, FDA-2011-M-0848..........  BSD Medical Corp.....  BSD-2000              November 18, 2011.
                                                            hyperthermia system.
P110010, FDA-2011-M-0865..........  Boston Scientific      PROMUS ELEMENT PLUS   November 22, 2011.
                                     Corp.                  EVEROLIMUS-eluting
                                                            platinum chromium
                                                            coronary stent
                                                            system.
P100024, FDA-2011-M-0866..........  Dako Denmark A/S.....  HER2 CISH PHARMDX     November 30, 2011.
                                                            kit.
P110025, FDA-2011-M-0917..........  Roche Diagnostics      ELECSYS anti-HBC IGM  December 14, 2011.
                                     Corp.                  immunoassay and
                                                            ELECSYS
                                                            PRECICONTROL anti-
                                                            HBC IGM for use on
                                                            the MODULAR
                                                            ANALYTICS E170
                                                            immunoassay analyze.
P100046, FDA-2011-M-0910..........  AtriCure Inc.........  ATRICURE SYNERGY      December 14, 2011.
                                                            ablation system.
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm; and
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/HDEApprovals/ucm161827.htm.

    Dated: March 12, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6390 Filed 3-15-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Rules and Regulations]
[Pages 42506-42507]
[FR Doc No: 2016-15439]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2016-0280]

Drawbridge Operation Regulation; Chambers Creek, Steilacoom, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations; request for
comments.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Chambers Creek Burlington Northern
Santa Fe railroad vertical lift railroad bridge across Chambers Creek,
mile 0.01, near

Steilacoom in Pierce County, WA. This deviation will test a change to
the drawbridge operation schedule to determine whether a permanent
change to the schedule is appropriate. This test deviation will modify
the existing regulation to add an advance notification requirement for
obtaining bridge openings during designated evening hours.

DATES: This deviation is effective from 12:01 on July 1, 2016 to 12:01
on December 27, 2016.
    Comments and related material must reach the Coast Guard on or
before November 22, 2016.

ADDRESSES: You may submit comments identified by docket number USCG-
2016-0280 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.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Steven Fischer, Bridge
Administrator, Thirteenth Coast Guard District; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background, Purpose and Legal Basis

    The Chambers Creek Burlington Northern Santa Fe railroad vertical
lift railroad bridge across Chambers Creek, mile 0.01, near Steilacoom
in Pierce County, WA has a vertical clearance of 10ft in the closed to
navigation position and 50ft of vertical clearance in the open to
navigation position (reference plane is MHW elevation of 12.2 feet).
The bridge currently operates under 33 CFR 117.5; which requires the
bridge to open anytime when a request or signal to open is given.
    The bridge owner, Burlington Northern Santa Fe Railroad, has
observed minimal to no usage of the drawbridge between 10 p.m. and 6
a.m. and has requested to test this schedule to see if it better
balances the needs of marine and rail traffic. The following facts
support BNSF's proposal: (1) Over the last 6 years only 2% of the
subject bridge lifts have occurred between the hours of 10 p.m. and 6
a.m., which equates to approximately 5 openings a year, (2) from
February 2009 to June 2015 there were 1932 total openings of which only
40 occurred between the hours of 10 p.m. and 6 a.m., and (3) the
navigation traffic consists primarily of the tenants of Chambers Bay
marina (recreational users) that are members of the Chambers Bay
Boating Association.
    The Coast Guard is publishing this temporary deviation to test the
proposed schedule change to determine whether a permanent change to the
schedule is appropriate to better balance the needs of marine and rail
traffic.
    Under this temporary deviation, in effect from 12:01 on July 1,
2016 to 12:01 December 27, 2016, the subject bridge shall open on
signal, except from 10 p.m. to 6 a.m. the draw shall open on signal if
at least 4 hours notice is given. The bridge will be required to open
as soon a possible, no later than 1 hour after notification, for
vessels engaged in emergency response.
    The Coast Guard will inform the users of the waterways of this
temporary deviation through our Local and Broadcast Notices to Mariners
and through direct outreach with the Chambers Creek Boating Association
so that vessel operators can arrange their transits to minimize any
impact caused by the temporary deviation. Vessels able to pass
underneath the bridge in the closed position may do so at anytime.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

II. 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 of temporary deviation, 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.

    Dated: June 23, 2016.
Steven M. Fischer,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2016-15439 Filed 6-29-16; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 17 (Thursday, January 28, 2021)]
[Notices]
[Pages 7454-7456]
[FR Doc No: 2021-01807]

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DEPARTMENT OF TRANSPORTATION

[DOT-OST-2021-0009]

Solicitation for Annual Combating Human Trafficking in
Transportation Impact Award

AGENCY: Office of the Secretary of Transportation, U.S. Department of
Transportation.

ACTION: Notice.

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SUMMARY: The annual Combating Human Trafficking in Transportation
Impact Award (the award) incentivizes an increase in human trafficking
awareness, training, and prevention among transportation stakeholders.
The award is a component of the Department's Transportation Leaders
Against Human Trafficking initiative. Additional information regarding
the Department's counter-trafficking activities can be found at
www.transportation.gov/stophumantrafficking.
    The award serves as a platform for transportation stakeholders to
unlock their creativity, and to empower them to develop impactful and
innovative counter-trafficking tools, initiatives, campaigns, and
technologies that can help defeat this heinous crime. The award is open
to individuals and entities, including non-governmental organizations,
transportation industry associations, research institutions, and State
and local government organizations. Entrants compete for a cash award
of up to $50,000 to be awarded to the individual(s) or entity selected
for creating the most impactful counter-trafficking initiative or
technology. The U.S. Department of Transportation intends to
incentivize individuals and entities to think creatively in developing
innovative solutions to combat human trafficking in the transportation
industry, and to share those innovations with the broader community.

DATES: Submissions accepted January 28, 2021 through midnight PST on
March 1, 2021.

FOR FURTHER INFORMATION CONTACT: For more information, and to register
your intent to compete individually or as part of a team, visit
www.transportation.gov/stophumantrafficking, email<EMAIL_ADDRESS>
or contact the Office of International Transportation and Trade at
(202) 366-4398.

SUPPLEMENTARY INFORMATION:
    Award Approving Official: The Secretary of Transportation
(Secretary).
    Subject of Award Competition: Combating Human Trafficking in
Transportation Impact Award will recognize impactful and innovative
approaches to combating human trafficking in the transportation
industry.

Problem

    As many as 25 million men, women, and children are held against
their will and trafficked into forced labor and prostitution.
Transportation figures prominently in human trafficking enterprises
when traffickers move victims, which uniquely positions the industry to
combat the crime.

Challenge

    The Combating Human Trafficking in Transportation Impact Award is
looking for the best innovators to develop original, impactful, and
innovative human trafficking tools, initiatives, campaigns, and
technologies that can help defeat this heinous crime in the
transportation industry.

Eligibility

    To be eligible to participate in the Combating Human Trafficking in
Transportation Impact Award competition, private entities must be
incorporated in and maintain a primary place of business in the United
States, and individuals must be citizens or permanent residents of the
United States. There is no charge to enter the competition.

Rules, Terms, and Conditions

    The following additional rules apply:
    1. Entrants shall submit a project to the competition under the
rules promulgated by the Department in this Notice;
    2. Entrants must indemnify, defend, and hold harmless the Federal
Government from and against all third-party claims, actions, or
proceedings of any kind and from any and all damages, liabilities,
costs, and expenses relating to or arising from participant's
submission or any breach or alleged breach of any of the
representations, warranties, and covenants of participant hereunder.
Entrants are financially responsible for claims made by a third party;
    3. Entrants may not be a Federal entity or Federal employee acting
within the scope of employment;
    4. Entrants may not be an employee of the U.S. Department of
Transportation;
    5. Entrants shall not be deemed ineligible because an individual
used Federal facilities or consulted with Federal employees during a
competition if the facilities and employees are made available to all
individuals participating in the competition on an equitable basis;
    6. The entries cannot have been submitted in the same or
substantially similar form in any other previous Federally sponsored
promotion or Federally sponsored competition;
    7. Entrants previously awarded first place are not eligible to
reenter for the same or substantially similar project;
    8. Entries, which at the Secretary's sole discretion, are
determined to be

substantially similar to another entity's entry submitted to this
competition may be disqualified;
    9. The competition is subject to all applicable Federal laws and
regulations. Participation constitutes the entrants' full and
unconditional agreement to these rules and to the Secretary's
decisions, which are final and binding in all matters related to this
competition;
    10. Entries must be original, be the work of the entrant and/or
nominee, and must not violate the rights of other parties. All entries
remain the property of the entrant. Each entrant represents and
warrants that:
     Entrant is the sole author and owner of the submission;
     The entry is not the subject of any actual or threatened
litigation or claim;
     The entry does not and will not violate or infringe upon
the intellectual property rights, privacy rights, publicity rights, or
other legal rights of any third party; and
     The entry does not and will not contain any harmful
computer code (sometimes referred to as ``malware,'' ``viruses,'' or,
``worms'').
    11. By submitting an entry in this competition, entrants agree to
assume any and all risks and waive any claims against the Federal
Government and its related entities (except in the case of willful
misconduct) for any injury, death, damage, or loss of property, revenue
or profits, whether direct, indirect, or consequential, arising from
their participation in this competition, whether the injury, death,
damage, or loss arises through negligence of otherwise. Provided,
however, that by registering or submitting an entry, entrants and/or
nominees do not waive claims against the Department arising out of the
unauthorized use or disclosure by the agency of the intellectual
property, trade secrets, or confidential information of the entrant;
    12. The Secretary or the Secretary's designees have the right to
request additional supporting documentation regarding the application
from the entrants and/or nominees;
    13. Each entrant grants to the Department, as well as other Federal
agencies with which it partners, the right to use names, likeness,
application materials, photographs, voices, opinions, and hometown and
state for the Department's promotional purposes in any media, in
perpetuity, worldwide, without further payment or consideration;
    14. If selected, the entrant and/or nominee must provide written
consent granting the Department and any parties acting on their behalf,
a royalty-free, non-exclusive, irrevocable, worldwide license to
display publicly and use for promotional purposes the entry
(``demonstration license''). This demonstration license includes
posting or linking to the entry on Department websites, including the
Competition website, and partner websites, and inclusion of the entry
in any other media, worldwide;
    15. Applicants which are Federal grant recipients may not use
Federal funds to develop submissions;
    16. Federal contractors may not use Federal funds from a contract
to develop applications or to fund efforts in support of a submission;
and
    17. The submission period begins on [the date of FRN publication].
Submissions must be sent by 11:59 p.m. Pacific Standard Time on [30
days after the FRN publication]. The timeliness of submissions will be
determined by the postmark (if sent in hard copy) or time stamp of the
recipient (if emailed). Competition administrators assume no
responsibility for lost or untimely submissions for any reason.

Submission Requirements

    Applicants must submit entries via email or by mail. Electronic
packages may be transmitted by email to<EMAIL_ADDRESS>Hard
copies should be forwarded with a cover letter to the attention of:
Combating Human Trafficking in Transportation Impact Award (Room W88-
121), 1200 New Jersey Avenue SE, Washington, DC 20590.
    Expression of Interest: While not required, entrants are strongly
encouraged to send brief expressions of interest to the DOT prior to
submitting entries. The expressions of interest should be sent by [10
days after the FRN publication] to<EMAIL_ADDRESS>and include the
following elements: (1) Name of entrant/s; (2) Telephone and email
address; and (3) A synopsis of the concept, limited to no more than two
pages.
    Complete submission packages shall consist of the following
elements:

1. Eligibility Statement

    A statement of eligibility by private entities indicating that they
are incorporated in and maintain a primary place of business in the
United States, or a statement of eligibility by individuals indicating
that they citizens or permanent residents of the United States.

2. Summary (1-2 pages)

    An overall summary of the project that includes
    A. Entity: The name of the submitting individual(s) or
organization, their title, phone, and email. If the point of contact
for the project is different, also specify their name, title, phone,
and email.
    B. Title: The project title.
    C. Mode: Specify which transportation mode(s) the project will
focus on.
    D. Summary: A brief one-paragraph synopsis of the proposed project.
    E. Impact: A description of how the project will be evaluated and
its potential impact on human trafficking in the transportation
industry.
    F. Background: Brief background regarding the submitting
individual(s) or organization(s) that includes project-related
expertise.
    G. Partners: If applicable, list partners who will be engaged in
project development and/or implementation.

3. Supporting Documents (no page limit)

    The paper(s) and/or technologies, programs, video/audio files, and
other related materials, describing the project and addressing the
selection criteria. As applicable, this can include a description of
success of a previous or similar project and/or documentation of
impact. You may also submit supporting letters, which may be from
subject matter experts or industry, which may address the technical
merit of the concept, originality, impact, practicality, measurability
and/or applicability. DOT may request additional information, including
supporting documentation, more detailed contact information, releases
of liability, and statements of authenticity to guarantee the
originality of the work. Failure to respond in a timely manner may
result in disqualification.

Initial Screening

    The Office of International Transportation and Trade will initially
review applications to determine that all required submission elements
are included, and to determine compliance with eligibility
requirements.

Evaluation

    After the Initial Screening, the Office of International
Transportation and Trade, with input from the relevant Operating
Administrations, will judge entries based on the factors described
below: Technical merit, originality, impact, practicality,
measurability, and applicability. All factors are important and will be
given consideration.
    The Secretary will make the final selection.
    The Department reserves the right to not award the prize if the
selecting

officials believe that no submission demonstrates sufficient potential
for sufficient transformative impact.

Technical Merit

     Presents a clear understanding of the issue of human
trafficking in the transportation industry.
     Presents a logical and workable solution and approach to
addressing human trafficking in the transportation industry.
     Survivors of human trafficking were consulted in the
development of the project.

Originality

     The concept is new or a variation of an existing idea.
     The concept possesses and clearly describes its unique
merits.

Impact

     The project can make a significant impact and/or
contribution to the fight against human trafficking in the
transportation industry.
     The project clearly describes the breadth of impact.

Practicality

     The project clearly identifies anticipated beneficiaries
of the project.
     The project clearly outlines anticipated resources and all
costs to be incurred by executing the concept.
     The project can be implemented in a way that requires a
finite amount of resources (specifically, the submission has fixed
costs, low or no marginal costs, and a clear path to implementation and
scale beyond an initial investment).

Measurability

     The submission clearly outlines how the project will be
measured.
     The project will result in measurable improvements.

Applicability

     The project is national and/or can be scaled nationally.

Award

    Up to three winning entries are expected to be announced. The
first-place winner will receive up to a $50,000 cash prize. A plaque
with the first-place winner(s) name and the date of the award will be
on display at the U.S. Department of Transportation, and a display copy
of the plaque(s) will be sent to the first-place award winner's
headquarters. At the discretion of the Secretary, up to two additional
plaques may be awarded to recognize two runners up. At the option of
the Secretary of Transportation, DOT may pay for invitational travel
expenses to Washington, DC for up to two individuals or representatives
of the first-place winning organization and runners up organizations
should selectees be invited to present their project/s for DOT
officials.

    Authority: 15 U.S.C. 3719 (America COMPETES Act).

Joel Szabat,
Deputy Assistant Secretary, Aviation and International Affairs.
[FR Doc. 2021-01807 Filed 1-27-21; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: August 26, 2009 (Volume 74, Number 164)]
[Notices]
[Page 43194-43196]
[DOCID:fr26au09-130]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60537; File No. SR-ISE-2009-63]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Fee Changes

August 19, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 7, 2009, the International Securities Exchange, LLC (the
``Exchange'' or the ``ISE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change, as described in
Items I, II, and III below, which items have been prepared by the self-
regulatory organization. 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.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend its Schedule of Fees to establish
fees for transactions in options on a narrow based index. The text of
the proposed rule change is available on the Exchange's Web site
(http://www.ise.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 self-regulatory organization
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 self-regulatory organization
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 is proposing to amend its Schedule of Fees
to establish fees for transactions in options on the Morgan Stanley
Retail Index (``MVR'').\3\ The Exchange is proposing to adopt an
execution fee for all transactions in options on MVR.\4\ There will be
no execution fee for Public Customer Orders \5\ in MVR. All Firm
Proprietary orders will be charged $0.20 per contract. The amount of
the execution fee for all ISE Market Maker transactions shall be equal
to the execution fee currently charged by the Exchange for ISE Market
Maker transactions in equity options.\6\ Finally, the amount of the
execution fee for all non-ISE Market Maker transactions shall be $0.45
per contract.\7\
---------------------------------------------------------------------------

    \3\ The Exchange represents that MVR is eligible for options
trading because it meets the standards of ISE Rule 2002(d), which
allows the ISE to begin trading this product by filing Form 19b-4(e)
at least [sic] five business days after commencement of trading
pursuant to Rule 19b-4(e) of the Act.
    \4\ These fees will be charged only to Exchange members. Under a
pilot program that is set to expire on July 31, 2010, these fees
will also be charged to Linkage Principal Orders (``Linkage P
Orders'') and Linkage Principal Acting as Agent Orders (``Linkage P/
A Orders''). The amount of the execution fee charged by the Exchange
for Linkage P Orders and Linkage P/A Orders is $0.27 per contract
side and $0.18 per contract side, respectively. See Securities
Exchange Act Release No. 60175 (June 25, 2009), 74 FR 32026 (July 6,
2009) (SR-ISE-2009-36).
    \5\ Public Customer Order is defined in Exchange Rule 100(a)(39)
as an order for the account of a Public Customer. Public Customer is
defined in Exchange Rule 100(a)(38) as a person or entity that is
not a broker or dealer in securities.
    \6\ The Exchange applies a sliding scale, between $0.01 and
$0.18 per contract side, based on the number of contracts an ISE
market maker trades in a month.
    \7\ The amount of the execution fee for non-ISE Market Maker
transactions executed in the Exchange's Facilitation and
Solicitation Mechanisms is $0.19 [sic] per contract.
---------------------------------------------------------------------------

    Additionally, the Exchange has entered into a license agreement
with Morgan Stanley & Co., Inc. in connection with the listing and
trading of options on MVR. As with certain other licensed options, to
defray the licensing costs, the Exchange is adopting a surcharge fee of
fifteen (15) cents per contract for trading in options on MVR. The
Exchange believes charging the participants that trade this instrument
is the most equitable means of recovering the costs of the license.
However, because of competitive pressures in the industry, the Exchange
proposes to exclude Public Customer Orders from this surcharge fee.
Accordingly, this surcharge fee will only be charged to Exchange
members with respect to non-Public Customer Orders (e.g., ISE Market
Maker, non-ISE Market Maker & Firm Proprietary orders) and Linkage
Orders. The Exchange believes the proposed rule change will further
ISE's goal of introducing new products to the marketplace at a
competitive price.
    2. Basis--The Exchange believes that the proposed rule change is
consistent with the objectives of Section 6 of the Act,\8\ in general,
and furthers the objectives of Section 6(b)(4),\9\ in particular, in
that it is designed to provide for the equitable allocation of
reasonable dues, fees and other charges among its members and other
persons using its facilities. In particular, the Exchange believes the
proposed rule change will further the Exchange's goal of introducing
new products to the marketplace at a competitive priced.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f.
    \9\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3) of the Act \10\ and Rule 19b-4(f)(2) \11\ thereunder. At any
time within 60 days of the filing of such proposed rule change, the
Commission may summarily abrogate such rule change if it appears to the
Commission that such action is necessary or appropriate in the public
interest, for the protection of investors, or otherwise in furtherance
of the purposes of the Act.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A). [sic]
    \11\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposal 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2009-63 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2009-63. This file
number should be included on the subject line if e-mail 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 Web site (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 inspection and copying in the Commission's Public
Reference Room, 100 F Street, NE., Washington, DC 20549, on official
business days between the hours of 10 a.m. and 3 p.m. Copies of such
filing also will be available for inspection and copying at the
principal office of ISE. All comments received will be posted without
change; the Commission does not edit personal identifying information
from submissions. You should submit only information that you wish to
make available publicly. All submissions should refer to File Number
SR-ISE-2009-63 and should be submitted on or before September 16, 2009.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-20543 Filed 8-25-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: June 22, 2010 (Volume 75, Number 119)]
[Notices]
[Page 35451-35452]
[DOCID:fr22jn10-46]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2010-0485; FRL 9166-6]

Access by EPA Contractors To Information Claimed as Confidential
Business Information (CBI) Submitted Under Title II of the Clean Air
Act and Related to the Renewable Fuel Standard (RFS2) and the EPA
Moderated Transaction System (EMTS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: EPA's Office of Transportation and Air Quality (OTAQ) plans to
authorize various contractors to access information which will be
submitted to EPA under Title II of the Clean Air Act that may be
claimed as, or may be determined to be, confidential business
information (CBI). Contractor access to this information, which is
related to the Renewable Fuel Standard (RFS2) and its EPA Moderated
Transaction System (EMTS), will begin on July 1, 2010.

DATES: EPA will accept comments on this Notice through June 28, 2010.

FOR FURTHER INFORMATION CONTACT: Anne-Marie C. Pastorkovich,
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW. (6406J),
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
343-2801; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this Notice Apply to Me?

    This action is directed to the general public. However, this action
may be of particular interest to parties who are required to use the
EPA Moderated Transaction System (EMTS), as described in 40 CFR
80.1452(e), to manage and convey renewable identification numbers
(RINs). EMTS is utilized by parties subject to registration and
reporting under the Renewable Fuel Standard (RFS2) program of 40 CFR
part 80, subpart M.\1\
---------------------------------------------------------------------------

    \1\  See ``Regulation of Fuel and Fuel Additives: Changes to
Renewable Fuel Standard Program--Final Rule,'' 75 FR 14670 (March
26, 2010) and ``Regulation of Fuel and Fuel Additives: Modifications
to Renewable Fuel Standard Program--Final Rule and Proposed Rule,''
75 FR 26026 (May 10, 2010).
---------------------------------------------------------------------------

    This Federal Register notice may be of particular relevance to
parties that have submitted data under the above-listed programs or
systems. Since other parties may also be interested, the Agency has not
attempted to describe all the specific parties that may be affected by
this action. If you have further questions regarding the applicability
of this action to a particular party, please contact the person listed
in FOR FURTHER INFORMATION CONTACT.

II. How Can I Get Copies of this Document and Other Related
Information?

A. Electronically

    EPA has established a public docket for this Federal Register
notice under Docket EPA-HQ-OAR-2010-0485.
    All documents in the docket are identified in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, such as confidential
business information (CBI) or other information for which disclosure is
restricted by statute. Certain materials, such as copyrighted material,
will only be available in hard copy at the EPA Docket Center.

B. EPA Docket Center

    Materials listed under Docket EPA-HQ-OAR-2010-0485 will be
available for public viewing at the EPA Docket Center (EPA/DC), EPA
West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC 20460.
The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Air Docket is<PHONE_NUMBER>.

III. Description of Programs and Potential Disclosure of Information
Claimed as Confidential Business Information (CBI) to Contractors

    EPA's Office of Transportation and Air Quality (OTAQ) has
responsibility for protecting public health and the environment by
regulating air pollution from motor vehicles, engines, and the fuels
used to operate them, and by encouraging travel choices that minimize
emissions. In order to implement various Clean Air Act programs, and to
permit regulated entities flexibility in meeting regulatory
requirements (e.g., compliance on average), we collect compliance
reports and other information from them. Occasionally, the information
submitted is claimed to be confidential business information (CBI).
Information submitted under such a claim is handled in accordance with
EPA's regulations at 40 CFR part 2, subpart B and in accordance with
EPA procedures, including comprehensive system security plans (SSPs)
that are consistent with those regulations. When EPA has determined
that disclosure of information claimed as CBI to contractors is
necessary, the corresponding contract must address the appropriate use
and handling of the information by the contractor and the contractor
must require its personnel who require access to information claimed as
CBI to sign written non-disclosure agreements before they are granted
access to data.
    In accordance with 40 CFR 2.301(h), we have determined that the
contractors, subcontractors, and grantees (collectively referred to as
``contractors'') listed below require access to CBI submitted to us
under the Clean Air Act and in connection with the RFS2 program and
EMTS. We are providing notice and an opportunity to comment. OTAQ
collects this data in order to monitor compliance with the RFS2 program
and to permit regulated parties flexibility in meeting regulatory
requirements through the trading of RINs. We are issuing this Federal
Register notice to inform all submitters of information within the EMTS
system that we plan to grant access to material that may be claimed as
CBI to the contractors identified below on a need-to-know basis.
    Under Contract Number EP-W-09-22, PowerSolv, Incorporated, 1801
Robert Fulton Drive 550, Reston, Virginia, 20191 and its
subcontractor, Indus Corporation, 1951 Kidwell Drive--8th Floor,
Vienna, Virginia, 22182 provides technical support and information
technology services that involve access to information claimed as CBI
related to EMTS. Access to EMTS data, including information claimed as
CBI, will commence on July 1, 2010 and will continue until May 31,
2011. If the contract is extended, this access will continue for the
remainder of the contract without further notice.
    Under Contract Number EP-06-095, Compass Solutions, Incorporated,
2760 Eisenhower Avenue, Suite 404, Alexandria, Virginia 22314 provides
report processing and program support that involves access to
information claimed as CBI related to EMTS. Access to EMTS data,
including information claimed as CBI, will commence on July 1, 2010 and
will continue until

September 30, 2010. If the contract is extended, the access described
in this paragraph will continue for the remainder of the contract and
any further extensions without further notice.
    Under Contract Number EP-W-09-021, Perrin Quarles Associates (PQA),
Inc.,\2\ 652 Peter Jefferson Parkway, Suite 300, Charlottesville,
Virginia, 22911 provides technical and analytical support that involves
access to information claimed as CBI related to EMTS. Access to data,
including information claimed as CBI, will commence on July 1, 2010 and
will continue until April 14, 2011. If the contract is extended, this
access will continue for the remainder of the contract and any further
extensions without further notice.
---------------------------------------------------------------------------

    \2\ On January 25, 2010, PQA announced that it had been acquired
by SRA International (SRA) of Fairfax, Virginia.
---------------------------------------------------------------------------

    Under Contract Number GS35F4797H, CGI, Incorporated, 12601 Fair
Lakes Circle, Fairfax, Virginia, 22033 provides technical and
information technology support related to submission of data via EPA's
Central Data Exchange (CDX) and EMTS. Access to fuels data, including
information claimed as CBI, will commence on July 1, 2010 and will
continue until March 31, 2012. If the contract is extended, this access
will continue for the remainder of the contract and any further
extensions without further notice.
    Under Contract Number EP10H000097, Computer Science Corporation
(CSC), 15000 Conference Center Drive, Chantilly, Virginia 20151-3808,
provides technical and information technology support that involves
access to information claimed as CBI related to EMTS. Access to data,
including information claimed as CBI, will commence on July 1, 2010 and
will continue until September 30, 2010. If the contract is extended,
this access will continue for the remainder of the contract and any
further extensions without further notice.
    Under Contract Number GS00T99ALD0203, Task Order EP09H002180, EXCEL
Management Systems, Inc., 691 N High Street, Floor 2, Columbus, Ohio,
43215, provides technical and information technology support that
involves access to information claimed as CBI related to EMTS. Access
to data, including information claimed as CBI, will commence on July 1,
2010 and will continue until June 30, 2011. If the contract is
extended, this access will continue for the remainder of the contract
and any further extensions without further notice.
    OTAQ utilizes the services of enrollees under the Senior
Environmental Employment (SEE) program. Some SEE enrollees are provided
through Grant Number CQ-83880-01, Senior Service America, Inc., (SSAI),
8403 Colesville Road, Suite 1200, Silver Spring, Maryland 20910-3314.
SEE enrollees are also provided through Grant Number CQ-833436, the
National Association for Hispanic Elderly (NAHE), 234 E. Colorado
Blvd., Suite 300, Pasadena, California 91101. Access to data related to
EMTS, including information claimed as CBI will commence on July 1,
2010 and will continue until August 31, 2011. If these grants are
extended, this access will continue for the remainder of the grants and
any future extensions without further notice.
    Parties who wish further information about this Federal Register
notice or about OTAQ's disclosure of information claimed as CBI to
contactors may contact the person listed under FOR FURTHER INFORMATION
CONTACT.

List of Subjects

    Environmental protection; confidential business information.

    Dated: June 4, 2010.
Karl J. Simon,
Director, Compliance and Innovative Strategies Division, Office of
Transportation & Air Quality, Office of Air and Radiation.
[FR Doc. 2010-15032 Filed 6-21-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 142 (Tuesday, July 26, 2022)]
[Notices]
[Pages 44407-44409]
[FR Doc No: 2022-15956]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1729]

Revocation of Emergency Use of a Drug During the COVID-19
Pandemic; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorization (EUA) (the Authorization)
issued to Gilead Sciences, Inc. (Gilead) for VEKLURY (remdesivir). FDA
revoked the Authorization on April 25, 2022, under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) given the approval of a supplemental
new drug application (NDA) for VEKLURY, which expanded the approved
indication to cover the authorized population. The revocation, which
includes an explanation of the reasons for the revocation, is reprinted
in this document.

DATES: The Authorization is revoked as of April 25, 2022.

ADDRESSES: Submit written requests for single copies of the
Authorization and/or revocation to the Office of Counterterrorism and
Emerging Threats, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4338, 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 Authorizations may be
sent. See the SUPPLEMENTARY INFORMATION section for electronic access
to the Authorizations.

FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4340, 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, nuclear, and radiological 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 May 1, 2020, FDA issued an
Authorization (EUA 046) to Gilead for remdesivir, subject to the terms
of the Authorization. Notice of the issuance of the Authorization was
published in the Federal Register on September 11, 2020 (85 FR 56231),
as required by section 564(h)(1) of the FD&C Act. Subsequent amendments
to the Authorization on August 28, 2020, October 1, 2020, October 16,
2020, October 22, 2020, and January 21, 2022, were made available on
FDA's website.

II. EUA Criteria for Issuance No Longer Met

    Under section 564(g)(2) of the FD&C Act, the Secretary of HHS may
revoke an EUA if, among other things, the criteria for issuance are no
longer met. On April 25, 2022, FDA revoked the EUA for VEKLURY because
the criteria for issuance were no longer met. Under section 564(c)(3)
of the FD&C Act, an EUA may be issued only if FDA concludes there is no
adequate, approved,\1\ and available alternative to the product for
diagnosing, preventing, or treating the disease or condition. On April
25, 2022, FDA approved a supplemental NDA to NDA 214787 for VEKLURY,
which expanded the approved indication to the following:
---------------------------------------------------------------------------

    \1\ In the context of section 564, the term ``approved'' refers
to a product that is approved, licensed, or cleared under section
505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k), or
360(e)) or section 351 of the Public Health Service Act (42 U.S.C.
262). See section 564(a)(2) of the FD&C Act.

    Veklury is a severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) nucleotide analog RNA polymerase inhibitor indicated
for the treatment of coronavirus disease 2019 (COVID-19) in adults
and pediatric patients (28 days of age and older and weighing at
least 3 kg) with positive results of direct SARS-CoV-2 viral
testing, who are:
     Hospitalized, or
     Not Hospitalized and have mild-to-moderate COVID-19 and
are at high risk for progression to severe COVID-19, including
hospitalization or death.

    FDA has concluded that VEKLURY approved under NDA 214787 is an
adequate, approved, and available alternative to the VEKLURY available
for emergency use for the treatment of COVID-19 for purposes of section
564(c)(3) of the FD&C Act. Accordingly, FDA revoked EUA 046 for
emergency use of VEKLURY, pursuant to section 564(g)(2) of the FD&C
Act.

III. Electronic Access

    An electronic version of this document and the full text of the
Authorization and revocation are available on the internet from https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization and https://www.regulations.gov/.

IV. The Revocation

    Having concluded that the criteria for revocation of the
Authorization under section 564(g) of the FD&C Act are met, FDA has
revoked the EUA for Gilead's VEKLURY (remdesivir). The revocation in
its entirety follows and provides an explanation of the reasons for
revocation, as required by section 564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN26JY22.158

[GRAPHIC] [TIFF OMITTED] TN26JY22.159

    Dated: July 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15956 Filed 7-25-22; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register: July 6, 2010 (Volume 75, Number 128)]
[Rules and Regulations]
[Page 38710-38712]
[DOCID:fr06jy10-6]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2009-0520]
RIN 1625-AA08

Special Local Regulation, Fran Schnarr Open Water Championships,
Huntington Bay, NY

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard is establishing a permanent Special Local
Regulation on the navigable waters of Huntington Bay, New York due to
the annual Fran Schnarr Open Water Championships. This Special Local
Regulation is necessary to provide for the safety of life by protecting
swimmers and their safety craft from the hazards imposed by marine
traffic. Entry into this zone is prohibited unless authorized by the
Captain of the Port Long Island Sound, New Haven, CT.

DATES: This rule is effective July 6, 2010.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2009-0520 and are available online by going to
http://www.regulations.gov, inserting USCG-2009-0520 in the ``Keyword''
box, and then clicking ``Search.'' This material is also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Chief Petty Officer Christie Dixon, Prevention
Department, USCG Sector Long Island Sound at<PHONE_NUMBER>,
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On March 22, 2010, the Coast Guard published a Supplemental Notice
of Proposed Rulemaking (SNPRM) entitled ``Special Local Regulation,
Fran Schnarr Open Water Championships, Huntington Bay, NY'' in the
Federal Register (75 FR 13454). The Coast Guard received no comments or
requests for meetings on the proposed rule.
    The Coast Guard is issuing this temporary final rule without the
30-day delayed effective date normally required by the Administrative
Procedure Act (APA) (5 U.S.C. 553(d)). Under 5 U.S.C. 553(d)(3), the
Coast Guard finds that good cause exists for making this rule effective
less than 30 days after publication in the Federal Register. To delay
the effective date in this case would be impractical and unnecessary.
Delay would be impractical because it would require that the event be
rescheduled, a change which would affect hundreds of persons. Delay is
also unnecessary because this event is not controversial; in the three
months since the initial notice of proposed rulemaking, exactly zero
comments have been received.

Basis and Purpose

    The Fran Schnarr Open Water Championships is an annual open water
swim on the waters of Huntington Bay, NY. This swim has historically
involved up to 150 swimmers and accompanying safety craft. Prior to
this rule there was not a permanent regulation in place to protect the
swimmers or safety craft from the hazards imposed by marine traffic. To
provide for the safety of life, the Coast Guard is establishing a
permanent special local regulation on the navigable waters of
Huntington Bay, New York that excludes all unauthorized persons and
vessels from approaching within 100 yards of any swimmer or safety
craft on the race course.

Background

    On October 6, 2009 the Coast Guard published a Notice of Proposed
Rulemaking with request for comments titled, ``Special Local
Regulation, Fran Schnarr Open Water Championships, Huntington Bay, NY''
(Docket number USCG-2009-0520) in the Federal Register (74 FR 51243).
The notice proposed a regulated area encompassing 100 yards around the
race course for the duration of the race. This provided safety of life
for swimmers and safety craft, but any vessel transiting through the
Bay would have to pass through the regulated area putting a burden on
vessel traffic. This regulated area was considered but was not chosen
due to its burden on vessel traffic.
    On March 22, 2010, the Coast Guard published a supplemental notice
of proposed rulemaking (SNPRM) entitled: Special Local Regulation, Fran
Schnarr Open Water Championships,

Huntington Bay, NY in the Federal Register (75 FR 13454).
    This notice proposes a 100 yard regulated area that encompasses the
swimmers and safety craft moving with them as they travel the race
course. This moving regulated area provides protection for swimmers and
safety craft with a much smaller regulated area. It allows vessels to
pass through the race course as long as they stay clear of the swimmers
and safety craft reducing the burden on vessel traffic. This proposal
was chosen because it provides the same amount of safety as the
previously proposed regulated area while being less of a burden on
vessel traffic.

Discussion of Comments and Changes

    No comments or requests for meetings were received. However, during
the final edits of the Final Rule we realized that the description of
the regulated area was incorrect and needed clarification. A
supplemental notice of proposed rulemaking with request for comments
was then published to provide clarification of the regulatory text and
minimize the regulated area.
    The changes in the text redefined the regulated area from 100 yards
of the race course to 100 yards from any swimmer or safety craft so
that it would not block the entire waterway. This will reduce the
burden on vessels by allowing them to pass through the race course as
long as they stay clear of the swimmers and safety craft.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. 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 rule will
not have a significant economic impact on a substantial number of small
entities. We did not receive any comments regarding the impact of small
entities.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the SNPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

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

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

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 rule will not result in
such expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights. As stated previously, there were no comments received from the
previous rulemaking.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does 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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with

applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., specifications of materials,
performance, design, or operation; test methods; sampling procedures;
and related management systems practices) that are developed or adopted
by voluntary consensus standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(h), of
the Instruction. This rule finalizes the establishment of a special
local regulation that was published as a Supplemental Notice of
Proposed Rulemaking with an invitation to comment on March 22, 2010. No
comments were received that would affect the assessment of
environmental impacts from this action. An environmental analysis
checklist and a categorical exclusion determination are available in
the docket where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  Authority: 33 U.S.C. 1233.

0
2. Add Sec.  100.122 to read as follows:

Sec.  100.122  Fran Schnarr Open Water Championships, Huntington Bay,
New York.

    (a) Regulated area. All navigable waters of Huntington Bay, NY
within 100 yards of any swimmer or safety craft on the race course
bounded by the following points: Start/Finish at approximate position
40[deg]54'25.8'' N 073[deg]24'28.8'' W, East Turn at approximate
position 40[deg]54'45'' N 073[deg]23'36.6'' W and a West Turn at
approximate position 40[deg]54'31.2'' N 073[deg]25'21'' W.
    (b) Definitions. The following definitions apply to this section:
Designated On-scene Patrol Personnel means any commissioned, warrant or
petty officer of the U.S. Coast Guard operating Coast Guard vessels who
have been authorized to act on the behalf of the Captain of the Port
Long Island Sound.
    (c) Special local regulations. (1) No person or vessel may approach
or remain within 100 yards of any swimmer or safety craft within the
regulated area during the enforcement period of this regulation unless
they are officially participating in the Fran Schnarr Open Water
Championships event or are otherwise authorized by the Captain of the
Port Long Island Sound or by Designated On-scene Patrol Personnel.
    (2) All persons and vessels must comply with the instructions from
Coast Guard Captain of the Port or the Designated On-scene Patrol
Personnel. The Designated On-scene Patrol Personnel may delay, modify,
or cancel the swim event as conditions or circumstances require.
    (3) Upon being hailed by a U.S. Coast Guard vessel by siren, radio,
flashing light or other means, the operator of the vessel must proceed
as directed.
    (4) Persons and vessels desiring to enter the regulated area within
100 yards of a swimmer or safety craft may request permission to enter
from the designated on scene patrol personnel by contacting them on
VHF-16 or by a request to the Captain of the Port Long Island Sound via
phone at<PHONE_NUMBER>.
    (d) Enforcement period. This rule is enforced from 7:15 a.m. to
11:30 a.m. on July 11, 2010 and thereafter on a specified day each July
to be determined on an annual basis. Notification of the specific date,
times and enforcement of the special local regulation will be made via
a Notice of Enforcement in the Federal Register, separate marine
broadcasts and local notice to mariners.

    Dated: June 1, 2010.
Daniel A. Ronan,
Captain, U.S. Coast Guard, Captain of the Port Long Island Sound.
[FR Doc. 2010-16367 Filed 7-2-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: April 22, 2009 (Volume 74, Number 76)]
[Notices]
[Page 18369]
[DOCID:fr22ap09-36]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP09-151-000]

National Fuel Gas Supply Corporation; Notice of Request Under
Blanket Authorization

April 16, 2009.
    Take notice that on April 14, 2009, National Fuel Gas Supply
Corporation (National Fuel), 6363 Main Street, Williamsville, New York
14221-5887, filed a prior notice request pursuant to Parts 157.205 and
157.216 of the Commission's regulations under the Natural Gas Act (NGA)
and National Fuel's blanket certificate issued in Docket No. CP83-4-
000, for authorization to abandon one injection/withdrawal well in
Wharton Storage Field located in Potter County, Pennsylvania, all as
more fully set forth in the application, which is on file with the
Commission and open to public inspection. The filing may also be viewed
on the Web at http://www.ferc.gov using the ``eLibrary'' link. Enter
the docket number excluding the last three digits in the docket number
field to access the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Specifically, National Fuel proposes to abandon one injection/
withdrawal well (Well WH-34) and the associated well line (TRW-34) in
Wharton Storage Field located in Potter County, Pennsylvania. National
Fuel states that Well WH-34 is no longer useful due to poor injection
performance and poor deliverability and needs to be reconditioned or
plugged due to deterioration of the well casing. National Fuel asserts
that all work will be confined to the existing well site. National Fuel
states that after Well WH-34 is plugged and abandoned, the well site
will be restored and revegetated. National Fuel also proposes to
abandon in place well line TRW-34, totaling approximately 1,200 feet of
6-inch diameter well line. National Fuel asserts that the cost to
construct similar facilities today is approximately $1 million.
National Fuel avers that the proposed abandonment will not result in a
material decrease in service to customers.
    Any questions regarding the application should be directed to David
W. Reitz, Deputy General Counsel, National Fuel Gas Supply Corporation,
6363 Main Street, Williamsville, New York 14221-5887, at (716) 857-
7949.
    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's regulations under
the NGA (18 CFR 157.205) file a protest to the request. If no protest
is filed within the time allowed therefore, the proposed activity shall
be deemed to be authorized effective the day after the time allowed for
protest. If a protest is filed and not withdrawn within 30 days after
the time allowed for filing a protest, the instant request shall be
treated as an application for authorization pursuant to section 7 of
the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the Internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-9229 Filed 4-21-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 80 (Friday, April 24, 2020)]
[Notices]
[Pages 23115-23117]
[FR Doc No: 2020-08704]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88703]

Order Granting Limited Exemptive Relief, Pursuant to Section 36
of the Securities Exchange Act of 1934 (``Exchange Act'') and Rule
608(e) of Regulation NMS Under the Exchange Act, Related to Certain
Introducing Brokers, From the Requirements of the National Market
System Plan Governing the Consolidated Audit Trail

April 20, 2020.
    By letter dated February 3, 2020, BOX Exchange LLC; Cboe BYX
Exchange, Inc.; Cboe BZX Exchange, Inc.; Cboe EDGA Exchange, Inc.; Cboe
EDGX Exchange, Inc.; Cboe C2 Exchange, Inc.; Cboe Exchange, Inc.;
Financial Industry Regulatory Authority, Inc. (``FINRA''); Investors
Exchange LLC; Long-Term Stock Exchange, Inc.; Miami International
Securities Exchange, LLC; MIAX Emerald, LLC; MIAX Pearl, LLC; Nasdaq
BX, Inc.; Nasdaq GEMX, LLC; Nasdaq ISE, LLC; Nasdaq MRX, LLC; Nasdaq
PHLX LLC; The Nasdaq Stock Market LLC; New York Stock Exchange LLC;
NYSE American LLC; NYSE Arca, Inc.; NYSE Chicago, Inc.; and NYSE
National, Inc. (collectively, the ``Participants'' to the National
Market System (``NMS'') Plan Governing the Consolidated Audit Trail
(``CAT NMS Plan'')) \1\ requested that the Securities and Exchange
Commission (``Commission'' or ``SEC''), pursuant to its authority under
Section 36 of the Securities Exchange Act of 1934 (``Exchange Act'')
\2\ and Rule 608(e) of Regulation NMS under the Exchange Act,\3\ grant
exemptive relief from certain provisions of the CAT NMS Plan related to
broker-dealers that do not qualify as Small Industry Members solely
because such broker-dealers satisfy Rule 0-10(i)(2) under the Exchange
Act \4\ in that they introduce transactions on a fully disclosed basis
to clearing firms that are not small businesses or small organizations
(for purposes of this order, such broker-dealers are referred to as
``Introducing Brokers'' or ``Introducing Industry Members'').\5\
Specifically, the Participants request that the Commission provide
exemptive relief from requiring Introducing Industry Members to comply
with the requirements of the CAT NMS Plan that apply to Industry
Members other than Small Industry Members (``Large Industry Members''),
provided that the Participants require such Introducing Industry
Members to comply with the requirements of the CAT NMS Plan that apply
to Small Industry Members.\6\ The Participants state that the CAT NMS
Plan permits Small Industry Members to begin reporting to the CAT later
than Large Industry Members.\7\
---------------------------------------------------------------------------

    \1\ The Commission approved the CAT NMS Plan, as modified, on
November 15, 2016. See Securities Exchange Act Release No. 79318
(November 15, 2016), 81 FR 84696 (November 23, 2016) (``CAT NMS Plan
Approval Order'').
    \2\ 15 U.S.C. 78mm(a)(1).
    \3\ 17 CFR 242.608(e).
    \4\ 17 CFR 240.0-10(i)(2).
    \5\ See letter from Mike Simon, CAT NMS Plan Operating Committee
Chair, to Vanessa Countryman, Secretary, U.S. Securities and
Exchange Commission, dated February 3, 2020 (``Exemption Request'').
Unless otherwise noted, capitalized terms are used as defined in
Rule 613 of Regulation NMS, in the CAT NMS Plan, or in this letter.
``Industry Member'' means ``a member of a national securities
exchange or a member of a national securities association.'' ``Small
Industry Member'' means ``an Industry Member that qualifies as a
small broker-dealer as defined in SEC Rule 613.'' See CAT NMS Plan
at Section 1.1.
    \6\ See Exemption Request.
    \7\ See id. at 2.
---------------------------------------------------------------------------

    Under the CAT NMS Plan, a Small Industry Member is an Industry
Member that qualifies as a small broker-dealer as defined in Rule 613
under the Exchange Act.\8\ Rule 613 incorporates the definition of
small broker-dealer in Rule 0-10(c) under the Exchange Act.\9\ Exchange
Act Rule 0-10(c) defines a small broker or dealer to mean a broker or
dealer that:
---------------------------------------------------------------------------

    \8\ 17 CFR 242.613. See CAT NMS Plan at Section 1.1.
    \9\ 17 CFR 240.0-10(c).

    (1) Had total capital (net worth plus subordinated liabilities)
of less than $500,000 on the date in the prior fiscal year as of
which its audited financial statements were prepared pursuant to
Sec.  240.17a-5(d) or, if not required to file such statements, a
broker or dealer that had total capital (net worth plus subordinated
liabilities) of less than $500,000 on the last business day of the
preceding fiscal year (or in the time that it has been in business,
if shorter); and
    (2) Is not affiliated with any person (other than a natural
person) that is not a small business or small organization as
defined in this section.

    Under Exchange Act Rule 0-10(i),\10\ a broker or dealer is
affiliated with another person for purposes of Exchange Act Rule 0-
10(c) if:
---------------------------------------------------------------------------

    \10\ 17 CFR 240.0-10(i).

    (1) Such broker or dealer controls, is controlled by, or is
under common control with such other person; a person shall be
deemed to control another person if that person has the right to
vote 25 percent or more of the voting securities of such other
person or is entitled to receive 25 percent or more of the net
profits of such other person or is otherwise able to direct or cause
the direction of the management or policies of such other person; or
    (2) Such broker or dealer introduces transactions in securities,
other than registered investment company securities or interests or
participations in insurance company separate accounts, to such other
person, or introduces accounts of customers or other brokers or
dealers, other than accounts that hold only registered investment
company securities or interests or participations in insurance
company separate accounts, to such other person that carries such
accounts on a fully disclosed basis.

    In the CAT NMS Plan Approval Order, the Commission stated that the
CAT NMS Plan provides a capital level-based definition of Small
Industry Members for purposes of the CAT NMS Plan implementation
schedule.\11\ The Commission further stated that the definition is
derived from Exchange Act Rule 0-10, which defines small entities under
the Exchange Act for purposes of the Regulatory Flexibility Act, and
reflects an ``existing regulatory standard that is an indication of
small entities for which regulators should be sensitive when imposing
regulatory burdens.'' \12\ The Commission stated that the definition of
Small Industry Member is a reasonable means to identify market
participants for which it would be appropriate to provide, and that
would benefit from, an additional year to prepare for CAT reporting due
to their relatively limited resources.\13\
---------------------------------------------------------------------------

    \11\ See CAT NMS Plan Approval Order, 81 FR at 84771.
    \12\ See id. (citing Securities Exchange Act Release No. 67457
(July 18, 2012), 77 FR 45722, 45804 (August 1, 2012) (``Rule 613
Adopting Release'')).
    \13\ See CAT NMS Plan Approval Order, 81 FR at 84771.
---------------------------------------------------------------------------

    Under Exchange Act Rule 0-10(i)(2), an Introducing Broker would not
be a small broker-dealer as defined in Exchange Act Rule 0-10(c) if the

Introducing Broker introduced transactions in securities on a fully
disclosed basis to a clearing firm that was not a small broker-dealer,
regardless of the Introducing Broker's capital level.\14\ The
Participants believe that excluding Introducing Brokers from the
definition of a small broker-dealer based on the introducing
relationship described in Exchange Act Rule 0-10(i)(2) is not
consistent with the intention to provide small broker-dealers with
additional time to comply with the CAT NMS Plan.\15\ The Participants
state that Introducing Brokers, as defined herein, are excluded from
the definition of a small broker-dealer solely because of their
introducing relationship with a clearing firm, and that Introducing
Brokers otherwise satisfy the capital threshold in Exchange Act Rule 0-
10(c)(1) for small broker-dealers.\16\ Accordingly, the Participants
request exemptive relief for Introducing Industry Members from the
requirements in the CAT NMS Plan applicable to Large Industry
Members.\17\
---------------------------------------------------------------------------

    \14\ Only broker-dealers that perform their own trading and
either self-clear or clear on an omnibus basis, rather than on a
fully disclosed basis, would be a small broker-dealer under Exchange
Act Rule 0-10(i)(2). See Exemption Request at 3.
    \15\ See id.
    \16\ See id.
    \17\ See id. at 4.
---------------------------------------------------------------------------

    The Participants state that the CAT NMS Plan permits Small Industry
Members to commence reporting to the CAT later than Large Industry
Members.\18\ As a condition to the exemption, the Participants would
require Introducing Industry Members to comply with the provisions of
the CAT NMS Plan applicable to Small Industry Members.\19\ As a result,
Introducing Industry Members would report information pursuant to the
CAT NMS Plan when Small Industry Members begin reporting.\20\ The
Participants state that the requested exemptive relief would affect
only the timing for when data would be reported, but not the type or
amount of data that would be reported.\21\
---------------------------------------------------------------------------

    \18\ See id. at 2.
    \19\ See id. Each Participant would be required to require
through its Compliance Rule that an Introducing Industry Member
comply with the requirements of the CAT NMS Plan applicable to Small
Industry Members. ``Compliance Rule'' means, ``with respect to a
Participant, the rule(s) promulgated by such Participant as
contemplated by Section 3.11.'' See CAT NMS Plan at Section 1.1.
    \20\ See id.
    \21\ See id.
---------------------------------------------------------------------------

    In a separate order, the Commission granted the Participants'
request for exemptive relief from certain requirements in the CAT NMS
Plan related to Industry Member reporting of Industry Member Data to
the Central Repository to allow for the implementation of phased
reporting for Industry Members to the CAT.\22\ The reporting schedule
in the Phased Reporting Order addresses Large Industry Members, Small
Industry Members that are required to record and report information to
FINRA's Order Audit Trail System pursuant to applicable self-regulatory
organization (``SRO'') rules (``Small Industry OATS Reporters''), and
Small Industry Members that are not required to record and report
information to FINRA's OATS pursuant to applicable SRO rules (``Small
Industry Non-OATS Reporters''). Under the relief requested herein, the
Participants would be exempt from requiring Introducing Brokers to
comply with the requirements of the Plan applicable to Large Industry
Members and the Participants would require Introducing Brokers to
comply with the requirements of the Plan applicable to Small Industry
Members. The implementation schedule that an Introducing Broker would
follow would depend upon whether the Introducing Broker was an OATS
Reporter or a Non-OATS Reporter. Specifically, by providing this
relief, Introducing Brokers who are OATS Reporters would follow the
schedule established for Small Industry OATS Reporters and Introducing
Brokers who are Non-OATS Reporters would follow the schedule for Small
Industry Non-OATS Reporters, as described in more detail in the Phased
Reporting Order.\23\
---------------------------------------------------------------------------

    \22\ See Securities Exchange Act Release No. 88702 (April 20,
2020) (Order Granting Conditional Exemptive Relief, Pursuant to Rule
608(e) of the Securities Exchange Act of 1934, from Sections 6.4,
6.7(a)(v) and 6.7(a)(vi) of the National Market System Plan
Governing the Consolidated Audit Trail) (``Phased Reporting
Order'').
    \23\ See id.
---------------------------------------------------------------------------

    Section 36 of the Exchange Act grants the Commission the authority,
with certain limitations, to ``conditionally or unconditionally exempt
any person, security, or transaction . . . from any provision or
provisions of [the Exchange Act] or of any rule or regulation
thereunder, to the extent that such exemption is necessary or
appropriate in the public interest, and is consistent with the
protection of investors.'' \24\ Rule 608(e) of Regulation NMS under the
Exchange Act provides that the Commission may exempt from the
provisions of an NMS plan, either unconditionally or on specified terms
and conditions, any self-regulatory organization or its members, if the
Commission determines that such exemption is consistent with the public
interest, the protection of investors, the maintenance of fair and
orderly markets, and the removal of impediments to, and perfection of
the mechanisms of, a national market system.
---------------------------------------------------------------------------

    \24\ 15 U.S.C. 78mm(a)(1).
---------------------------------------------------------------------------

    The Commission believes that, pursuant to Exchange Act Section 36,
this exemption is appropriate in the public interest and consistent
with the protection of investors, and that pursuant to Rule 608(e),
this exemption is consistent with the public interest, the protection
of investors, the maintenance of fair and orderly markets and the
removal of impediments to, and the perfection of the mechanisms of, a
national market system. This relief will provide Introducing Industry
Members that meet the capital standard in Exchange Act Rule 0-10(c)(1)
with additional time to prepare effectively for certain CAT reporting
phases depending on whether they are OATS Reporters, as described in
more detail in the Phased Reporting Order. The Commission believes that
the introducing relationship described in Exchange Act Rule 0-10(i)(2)
should not prevent an Introducing Broker that meets the capital
standard in Exchange Act Rule 0-10(c)(1) from being considered a Small
Industry Member. The Commission understands that despite their clearing
relationships, these Introducing Industry Members have the same
resource limitations as other small broker-dealers that are similarly
capitalized. Additionally, although an Introducing Broker may rely on
its clearing firm to meet its regulatory obligations, an Introducing
Broker is not obligated to choose its clearing firm as its CAT
reporting agent. As the Commission stated in adopting Rule 613,
providing small broker-dealers with a longer implementation time would
assist small broker-dealers in identifying the most cost-effective and
the most efficient manner to comply with Rule 613.\25\ The Commission
believes that this rationale applies equally to all broker-dealers that
meet the capital threshold required to be considered a Small Industry
Member, including Introducing Brokers. This relief affects only the
time when certain Introducing Industry Members begin CAT reporting, but
not the type or amount of information that they will be required to
report. Accordingly, the Commission believes that the Participants
should be exempt from requiring Introducing Industry Members that meet
the capital standard in Exchange Act Rule 0-10(c)(1) to comply with the
requirements of the CAT NMS Plan applicable to Large Industry

Members, provided that such Introducing Industry Members comply with
the requirements of the CAT NMS Plan applicable to Small Industry OATS
Reporters and Small Industry Non-OATS Reporters, as applicable.
---------------------------------------------------------------------------

    \25\ See Rule 613 Adopting Release, 77 FR at 45804.
---------------------------------------------------------------------------

    Accordingly, it is hereby ordered, pursuant to Section 36(a)(1) of
the Exchange Act,\26\ and Rule 608(e) of the Exchange Act,\27\ that the
Participants are exempt from requiring Introducing Industry Members to
comply with the requirements of the CAT NMS Plan that apply to Large
Industry Members, provided that each Participant, through its
Compliance Rule, requires such Introducing Industry Members to comply
with the requirements of the CAT NMS Plan applicable to Small Industry
Members.
---------------------------------------------------------------------------

    \26\ 15 U.S.C. 78mm(a)(1).
    \27\ 17 CFR 242.608(e).

    By the Commission.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-08704 Filed 4-23-20; 8:45 am]
BILLING CODE 8011-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request U. S. Environmental Protection Agency Office of Solid Waste and Emergency Response 2. OMB control number b. G None a 2050 0053 3. Type of information collection ( check one) a. G New collection b. X Revision of a currently approved collection c. G Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. G Three years from approval date b. X Other Specify: 11/ 30/ 2004 7. Title: Identification Listing and Rulemaking Petitions ( Proposed rule for Wastewater Treatment Exemptions)

8. Agency form number( s) ( If applicable) : EPA ICR 1189.12 9. Keywords Environmental Protection, Hazardous Waste, Recycling, Waste Treatment and Disposal 10. Abstract EPA is proposing to add two solvents to the existing list of solvents that are eligible for the exemptions at 40 CFR 261.3( a)( 2)( iv)( A) or ( B). The solvents are benzene and 2 ethoxyethanol. EPA is also proposing that scrubber waters derived from the combustion of spent solvents and sent to a facility's wastewater treatment system qualify for the exemption under 40 CFR 261.3( a)( 2)( iv)( A) and ( B). In addition, the Agency is proposing to change the way compliance with certain of the exemptions at 261.3( a)( 2)( iv) is determined by adding the option of directly measuring solvent chemical levels at the headworks of the wastewater treatment system to the current requirements. Finally, the Agency is proposing to make additional listed hazardous wastes ( beyond discarded commercial chemical products) eligible for the de minimis exemption at 40 CFR 261.3( a)( 2)( iv)( D), as well as adding non manufacturing facilities to those that qualify for this exemption if certain conditions are met.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. X Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 1,840 b. Total annual responses 1,840 1. Percentage of these responses collected electronically 0 % c. Total annual hours requested 20,810 d. Current OMB inventory 20,809 e. Difference 1 f. Explanation of difference 1. Program Change 1 2. Adjustment 0 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs $ 0 b. Total annual costs ( O& M) $ 889 c. Total annualized cost requested $ 889 d. Current OMB inventory $ 888 e. Difference 1 f. Explanation of difference 1. Program change 1 2. Adjustment 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. Q Recordkeeping b. Q Third party disclosure c. Q Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biennually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes x No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Ron Josephson Phone: ( 703) 308 0442 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official Date Signature of Senior Official or designee Oscar Morales, Director Collections Strategies Division Date OMB 83 I 10/ 95