[Federal Register Volume 82, Number 67 (Monday, April 10, 2017)]
[Notices]
[Pages 17300-17302]
[FR Doc No: 2017-07101]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80378; File No. S7-03-14]

Order Granting a Temporary Exemption to Covered Clearing Agencies
From Compliance With Rule 17Ad-22(e)(3)(ii) and Certain Requirements in
Rules 17Ad-22(e)(15)(i) and (ii) Under the Securities Exchange Act of
1934

April 5, 2017.

I. Introduction

    On September 28, 2016, the Securities and Exchange Commission
(``Commission'') adopted amendments to Rule 17Ad-22 pursuant to Section
17A of the Securities Exchange Act of 1934 (``Exchange Act'') and Title
VIII of the Dodd-Frank Wall Street Reform and Consumer Protection Act
of 2010.\1\ Among other things, the amendments added new Rule 17Ad-
22(e), which establishes an enhanced regulatory framework for
registered clearing agencies that meet the definition of a covered
clearing agency.\2\ The amendments to Rule 17Ad-22 became effective on
December 12, 2016, and covered clearing agencies must be in compliance
with the amendments by April 11, 2017.\3\ For the reasons discussed
below, the Commission is using its authority under Section 17A(b)(1) of
the Exchange Act to grant covered clearing agencies a temporary
exemption from compliance with Rule 17Ad-22(e)(3)(ii) and certain
requirements in Rules 17Ad-22(e)(15)(i) and (ii) until December 31,
2017.
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    \1\ See Exchange Act Release No. 34-78961 (Sept. 28, 2016), 81
FR 70786 (Oct. 13, 2016) (``CCA Standards Adopting Release'').
    \2\ Under Rule 17Ad-22(a)(5), ``covered clearing agency'' means
(i) a designated clearing agency or (ii) a clearing agency involved
in activities with a more complex risk profile for which the
Commodity Futures Trading Commission is not the supervisory agency
as defined in Section 803(8) of the Payment, Clearing, and
Settlement Supervision Act of 2010 (``Clearing Supervision Act'').
See 17 CFR 240.17Ad-22(a)(5).
     In addition, Rule 17Ad-22(a)(6) defines ``designated clearing
agency'' to mean a clearing agency registered with the Commission
under Section 17A of the Exchange Act that is designated
systemically important by the Financial Stability Oversight Council
pursuant to the Clearing Supervision Act and for which the
Commission is the supervisory agency as defined in Section 803(8) of
the Clearing Supervision Act. Rule 17Ad-22(a)(4) defines ``clearing
agency involved in activities with a more complex risk profile'' to
mean a clearing agency registered with the Commission under Section
17A of the Exchange Act that: (i) Provides central counterparty
(``CCP'') services for security-based swaps; (ii) has been
determined by the Commission to be involved in activities with a
more complex risk profile at the time of its initial registration;
or (iii) is subsequently determined by the Commission to be involved
in activities with a more complex risk profile pursuant to Rule
17Ab2-2(b) under the Exchange Act. See 17 CFR 240.17Ad-22(a)(4),
(6).
    \3\ See CCA Standards Adopting Release at 70848.
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II. Background

    Rule 17Ad-22(e) generally requires a covered clearing agency to
establish, implement, maintain, and enforce written policies and
procedures reasonably designed to address, among other things, its
governance arrangements and risk management framework.\4\ Rule 17Ad-
22(e)(3) requires a covered clearing agency to establish, implement,
maintain and enforce policies and procedures reasonably designed to
maintain a sound risk management framework for comprehensively managing
legal, credit, liquidity, operational, general business, investment,
custody, and other risks that arise in or are borne by the covered
clearing agency, and which, among other things, includes plans for
recovery and orderly wind-down of the covered clearing agency
necessitated by credit losses, liquidity shortfalls, losses from
general business risk, or any other losses.\5\ In adopting Rule 17Ad-
22(e)(3)(ii), the Commission stated its belief that recovery and wind-
down plans, and material changes thereto, would constitute a proposed
rule change under Section 19(b) of the Exchange Act and, for designated
clearing agencies, an advance notice under the Clearing Supervision
Act, subjecting them to Commission review and public comment.\6\
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    \4\ See id. at 70792.
    \5\ 17 CFR 240.17Ad-22(e)(3)(ii).
    \6\ See CCA Standards Adopting Release at 70809.
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    In addition, Rule 17Ad-22(e)(15) requires a covered clearing agency
to establish, implement, maintain and enforce written policies and
procedures reasonably designed to identify, monitor, and manage the
covered clearing agency's general business risk and hold sufficient
liquid net assets funded by equity to cover potential general business
losses so that the covered clearing agency can continue operations and
services as a going concern if those losses materialize, including,
among other things, by (i) determining the amount of liquid net assets
funded by equity based upon its general business risk profile and the
length of time required to achieve a recovery or orderly wind-down, as
appropriate, of its critical operations and services if such action is
taken and (ii) holding liquid net assets funded by equity equal to the
greater of either (x) six months of its current operating expenses or
(y) the amount determined by the board of directors to be sufficient to
ensure a recovery or orderly wind-down of critical operations and
services of the covered clearing agency, as contemplated by the
recovery and wind-down plans established under Rule 17Ad-
22(e)(3)(ii).\7\
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    \7\ 17 CFR 240.17Ad-22(e)(15)(i), (ii).
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III. Discussion

A. Background and Exemptive Request

    As noted in the CCA Standards Adopting Release, the Commission
believes that, taken together, the policies and procedures requirements
related to recovery and wind-down plans in Rules 17Ad-22(e)(3)(ii) and
(15) should help ensure that a covered clearing agency is able to
remain resilient in times of market stress and to sustain its
operations for sufficient time to achieve orderly wind-down if such

action is necessary.\8\ Unlike some other aspects of Rule 17Ad-22(e),
until now recovery and wind-down plans have not been part of the
Commission's regulatory framework for registered clearing agencies.\9\
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    \8\ See CCA Standards Adopting Release at 70868, 70876.
    \9\ As discussed in CCA Standards Adopting Release, certain
requirements in Rule 17Ad-22(e) contain requirements substantially
similar to those in Rule 17Ad-22(d) or reflect current practices at
registered clearing agencies. Certain other requirements in Rule
17Ad-22(e) contain provisions that are similar to those in Rule
17Ad-22(d) but would also impose additional requirements not found
in Rule 17Ad-22(d). A few requirements have no comparable
requirement under Rule 17Ad-22(d) and therefore may require more
extensive changes to policies and procedures or other additional
steps to achieve compliance. See id. at 70891.
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    Since the adoption of Rule 17Ad-22(e), Commission staff has been
aware of the ongoing development of recovery and wind-down plans by
covered clearing agencies in anticipation of the April 11, 2017
compliance date. Nevertheless, the development of recovery and wind-
down plans continues to present novel and complex questions, and one
entity, on behalf of its three subsidiaries that are covered clearing
agencies, has requested that the Commission provide a temporary
exemption from compliance until December 31, 2017 so that the clearing
agencies can finalize their recovery and wind-down plans.\10\ The
entity states its view that recovery and wind-down plans are an
important new input into industry efforts to manage systemic risk that
must be carefully designed to address concerns unique to each covered
clearing agency and its members.\11\ The entity asserts that the topic
of recovery and wind-down remains under active discussion in the
industry, that a substantial amount of work remains to be completed,
and that it would be prudent to provide for a longer period of time for
consultation concerning the relevant documents and filings under the
Rule 19b-4 and advance notice processes related to recovery and wind-
down plans.\12\ The entity believes, in particular, that covered
clearing agencies, their members, and other interested persons would
benefit from further thought development concerning whether and how the
plans should address the continued provision of critical operations and
services in the event that recovery tools fail. The entity emphasizes
that additional time is necessary because of the complexity of the
planning process, the need for further discussion and consultation, and
the advisability of conducting appropriate member outreach prior to the
submission of formal filings under the Rule 19b-4 and advance notice
processes.\13\
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    \10\ See letter from Michael C. Bodson, President and Chief
Executive Officer, The Depository Trust & Clearing Corporation, Feb.
15, 2017, https://www.sec.gov/comments/s7-03-14/s70314-1594398-132354.pdf.
    \11\ See id. at 1.
    \12\ See id. at 2.
    \13\ See id.
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B. Exemptive Relief

    Section 17A(b)(1) of the Exchange Act provides that the Commission,
by order and upon its own motion, may conditionally or unconditionally
exempt any clearing agency or class of clearing agencies from any
provisions of Section 17A or the rules and regulations thereunder if
the Commission finds that such exemption is consistent with the public
interest, the protection of investors, and the purposes of Section 17A,
including the prompt and accurate clearance and settlement of
securities transactions and the safeguarding of securities and
funds.\14\
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    \14\ 15 U.S.C. 78q-1(b)(1).
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    Recognizing that the reasons stated by the entity may apply to
covered clearing agencies generally, the Commission believes that all
covered clearing agencies would benefit from additional time to
finalize the development of their recovery and wind-down plans. As
noted above, unlike some other aspects of Rule 17Ad-22(e), recovery and
wind-down plans continue to present novel and complex questions. The
recovery and wind-down plans described in Rule 17Ad-22(e)(3)(ii) are
new requirements not previously included in the Commission's regulatory
framework for clearing agencies, and the topics of recovery and wind-
down remain under active discussion in the industry. The Commission
believes that providing additional time to develop recovery and wind-
down plans will facilitate further discussion, consultation, and member
outreach by the covered clearing agencies that could help resolve the
novel and complex questions presented. This in turn would help promote
the development of plans that comprehensively address how a covered
clearing agency could continue to provide critical operations and
services in the event that recovery tools fail and that are consistent
with the policies and procedures requirements of Rule 17Ad-
22(e)(3)(ii). Therefore, the Commission finds that a temporary
exemption from compliance with Rule 17Ad-22(e)(3)(ii) until December
31, 2017 is consistent with the public interest, the protection of
investors, and the purposes of Section 17A of the Exchange Act.
    In addition, compliance with certain aspects of Rule 17Ad-22(e)(15)
depends in part on a covered clearing agency having established
recovery and wind-down plans under Rule 17Ad-22(e)(3)(ii).
Specifically, these include the following: (i) The requirement in Rule
17Ad-22(e)(15)(i) for policies and procedures for determining the
amount of liquid net assets funded by equity based upon the length of
time required to achieve a recovery or orderly wind-down, as
appropriate, of its critical operations and services if such action is
taken (``RWP clause''); and (ii) clause (y) of Rule 17Ad-22(e)(15)(ii)
requiring policies and procedures for holding liquid net assets funded
by equity equal to the amount determined by the board of directors to
be sufficient to ensure a recovery or orderly wind-down of critical
operations and services of the covered clearing agency, as contemplated
by the plans established under Rule 17Ad-22 (e)(3)(ii). The Commission
therefore finds that a temporary exemption from compliance with these
subsections of Rule 17Ad-22(e)(15) until December 31, 2017 is
consistent with the public interest, the protection of investors, and
the purposes of Section 17A of the Exchange Act.
    The Commission is not granting relief from the April 11, 2017
compliance date for any other provision of the amendments to Rule 17Ad-
22. In particular, the Commission notes that the temporary exemption
from compliance does not apply to either of the following: (i) The
requirement in Rule 17Ad-22(e)(15)(i) for policies and procedures for
determining the amount of liquid net assets funded by equity based upon
its general business risk profile; or (ii) clause (x) of Rule 17Ad-
22(e)(15)(ii) requiring policies and procedures for holding liquid net
assets funded by equity equal to six months of the covered clearing
agency's current operating expenses. Accordingly, as of the April 11,
2017 compliance date for the amendments to Rule 17Ad-22, a covered
clearing agency is required to have policies and procedures for
determining the amount of liquid net assets funded by equity based upon
its general business risk profile pursuant to Rule 17Ad-22(e)(15)(i)
and for holding liquid net assets funded by equity equal to six months
of the covered clearing agency's current operating expenses pursuant to
clause (x) of Rule 17Ad-22(e)(15)(ii), regardless of whether the
covered clearing agency has met the condition for obtaining relief
under this temporary exemption.
    As a condition to obtaining relief under the temporary exemption, a

covered clearing agency must notify the Commission in writing of its
intent to rely upon the temporary exemption no later than April 11,
2017.

IV. Conclusion

    The Commission hereby grants, pursuant to Section 17A(b)(1) of the
Exchange Act, covered clearing agencies a temporary exemption from
compliance with Rule 17Ad-22(e)(3)(ii), the RWP clause of Rule 17Ad-
22(e)(15)(i), and clause (y) of Rule 17Ad-22(e)(15)(ii) until December
31, 2017, subject to the condition contained in this order.

    By the Commission.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-07101 Filed 4-7-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: October 22, 2010 (Volume 75, Number 204)]
[Rules and Regulations]
[Page 65232-65236]
[DOCID:fr22oc10-14]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2009-0316]
RIN 1625-AA87

Security Zones; Sabine Bank Channel, Sabine Pass Channel and
Sabine-Neches Waterway, TX

AGENCY: Coast Guard, DHS.

ACTION: Interim rule with request comments.

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SUMMARY: The Coast Guard is issuing an interim rule based on comments
received from the subject Notice of Proposed Rulemaking published in
the Federal Register on May 27, 2010. This interim rule establishes
moving security zones for certain vessels for which the Captain of the
Port, Port Arthur deems enhanced security measures necessary. In
addition, it establishes security zones encompassing the mooring basins
of LNG carriers while they are moored at the Golden Pass LNG facility
in Sabine, TX and/or the Sabine Pass LNG facility located in Cameron
Parish, LA.

DATES: This interim rule is effective in the CFR on October 22, 2010.
This rule is effective with actual notice for the purposes of
enforcement on August 23, 2010. Comments and related material must be
received by the Coast Guard on or before November 22, 2010. Requests
for public meetings must be received by

the Coast Guard on or before November 1, 2010.

ADDRESSES: You may submit comments identified by docket number USCG-
2009-0316 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
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 interim
rule, call or e-mail Mr. Scott Whalen, Marine Safety Unit Port Arthur,
TX; telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>If you have
questions on viewing or submitting material to the docket, call Renee
V. Wright, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2009-0316), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail or hand
delivery, but please use only one of these means. If you submit a
comment online via  http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand delivery, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an e-mail address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. Insert ``USCG-2009-0316'' in the ``Keyword'' box.
Click ``Search'' then in the interim rule row click on the balloon
shape in the ``Actions'' column. If you submit comments by mail or hand
delivery, submit them in an unbound format, no larger than 8\1/2\ by 11
inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the Facility,
please enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and may change this rule based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the ``read comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box insert ``USCG-2009-0316'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the Docket Management Facility in Room W12-140 on
the ground floor of the Department of Transportation West Building,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one using one of the four methods specified under
ADDRESSES. Please explain why you believe a public meeting would be
beneficial. If we determine that one would aid this rulemaking, we will
hold one at a time and place announced by a later notice in the Federal
Register.

Regulatory Information

    On May 27, 2010, we published a notice of proposed rulemaking
(NPRM) entitled ``Security Zones; Sabine Bank Channel, Sabine Pass
Channel and Sabine-Neches Waterway, TX'' in the Federal Register (75 FR
29695). We received one comment on the proposed rule. No meetings were
requested and none were held.
    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. This finding is based on the fact
that the Coast Guard received only one comment concerning the published
NPRM and that the changes incorporated are not substantive. That is,
the changes will not result in any interference to normal vessel
traffic in the area. By making the interim rule effective less than 30
days after publication the necessary security zones can be implemented
without further delay. And, additional comments and the security zones
established by this interim rule will be evaluated throughout the
interim rule comment period.

Basis and Purpose

    The Coast Guard is establishing moving security zones for certain
vessels, for which the Captain of the Port deems enhanced security
measures are necessary. Mariners will be notified of the activation of
a moving security zone by Broadcast Notice to Mariners. Active moving
security zones may also be identified by the presence of escort vessels
displaying flashing blue law enforcement lights.
    The moving security zones would be activated for certain vessels
within the U.S. territorial waters through Sabine Bank Channel, Sabine
Pass Channel and the Sabine-Neches Waterway, extending from the surface
to the bottom. These moving security zones would extend channel edge to
channel edge on the Sabine Bank and Sabine Pass Channel and shoreline
to shoreline on the Sabine-Neches Waterway, 2 miles ahead and 1 mile
astern of the designated vessels while in transit. Meeting, crossing or
overtaking situations are not permitted within the security zone unless
specifically authorized by the Captain of the Port.
    In addition, the Coast Guard is establishing security zones for the

mooring basins at the Golden Pass LNG facility in Sabine, TX and the
Sabine Pass LNG facility located in Cameron Parish, LA while LNG
carriers are moored at these facilities.
    These proposed security zones would be part of a comprehensive port
security regime designed to safeguard human life, vessels, and
waterfront facilities against sabotage or terrorist attacks.
    All vessels not exempted under paragraph (b) of Sec.  165.819 would
be prohibited from entering or remaining in these security zones unless
authorized by the Captain of the Port, Port Arthur or his designated
representative. For authorization to enter the proposed security zones,
vessels can contact the Captain of the Port's on-scene representative
or Vessel Traffic Service Port Arthur on VHF Channel 01A or 65A, by
telephone at<PHONE_NUMBER>, or by facsimile at<PHONE_NUMBER>.

Discussion of Comments and Changes

    The Coast Guard received one comment requesting that the
establishment of a security zone extending 100-feet around LNG carriers
while moored at Sabine Pass LNG and Golden Pass LNG facilities be
extended to include the entire mooring basin. The Coast Guard concurs
with this recommendation and modified the regulatory language in Sec.
165.819 (a)(1) accordingly. Additionally, the commenter noted that the
location of the Sabine Pass facility should be changed from Cheniere,
LA to Cameron Parish, LA. This change was also incorporated into the
final regulatory language.

Regulatory Analyses

    We developed this interim 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.
    We expect the economic impact of this proposed rule to be so
minimal that a full Regulatory Evaluation is unnecessary. The basis of
this finding is that the proposed fixed security zones around moored
LNG carriers would be of limited size and duration and the affected
area would not hinder or delay regular vessel traffic. The moving
security zone wound be limited and would not create undue delay to
vessel traffic because vessel traffic may request permission to enter
the zone from the Captain of the Port.

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.
    This rule will affect the following entities, some of which might
be small entities: The owners or operators of vessels intending to
transit through the fixed or moving security zones. The fixed security
zones are of limited size and duration and the affected area will not
hinder or delay regular vessel traffic. The moving security zone rule
will not create undue delay to vessel traffic because vessel traffic
may request permission to enter the zone.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM 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 an 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.

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)(g), of
the Instruction. This rule addresses regulations establishing,
disestablishing, or changing Regulated Navigation Areas and security or
safety zones. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule. 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 165

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

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add new Sec.  165.819 to read as follows:

Sec.  165.819  Security Zone; Sabine Bank Channel, Sabine Pass Channel
and Sabine-Neches Waterway, TX.

    (a) Location. (1) The following LNG facility mooring basins are
designated as fixed security zones whenever LNG carriers are moored
within them:
    (i) Golden Pass LNG, Sabine TX: All waters south of a line
connecting the following points--beginning at 29[deg]45'58'' N,
093[deg]55'40'' W; then east to a point at 29[deg]45'52.8'' N,
093[deg]55'20.8'' W; then bearing 120[deg] T to the shoreline at
29[deg]45'50'' N, 093[deg]55'17'' W.
    (ii) Sabine Pass LNG, Cameron Parish, LA: All waters north of a
line connecting the following points--beginning at the shoreline in
position 29[deg]44'34.7'' N, 093[deg]52'29'' W; then southeast to a
point at 29[deg]44'31.4'' N, 093[deg]52'26.4'' W; then bearing 121[deg]
T to a point at 29[deg]44'25.2'' N, 093[deg]52'14.6'' W; then bearing
116[deg] T to the shoreline at 29[deg]44'23.75 N, 093[deg]52'00'' W.
    (2) The following areas are designated as moving security zones:
All waters of the Captain of the Port, Port Arthur Zone commencing at
U.S. territorial waters and extending from the surface to the bottom,
channel edge to channel edge on the Sabine Bank and Sabine Pass
Channels and shoreline to shoreline on the Sabine-Neches Waterway, 2
miles ahead and 1 mile astern of certain designated vessels while in
transit within in the Captain of the Port, Port Arthur zone. Mariners
would be notified of designated vessels by Broadcast Notice to Mariners
and the presence of escort vessels displaying flashing blue law
enforcement lights.
    (b) Regulations. (1) Entry into or remaining in a fixed security
zone described in paragraph (a)(1) of this section is prohibited for
all vessels except:
    (i) Commercial vessels operating at waterfront facilities within
these zones;
    (ii) Commercial vessels transiting directly to or from waterfront
facilities within these zones;
    (iii) Vessels providing direct operational or logistical support to
commercial vessels within these zones;
    (iv) Vessels operated by the appropriate port authority or by
facilities located within these zones; and
    (v) Vessels operated by Federal, State, county, or municipal law
enforcement agencies.
    (2) Entry into or remaining in a moving security zone described in
paragraph (a)(2) of this section is prohibited for all vessels except:
    (i) Moored vessels or vessels anchored in a designated anchorage
area. A moored or an anchored vessel in a security zone described in
paragraph (a)(2) of this section must remain moored or anchored unless
it obtains permission from the Captain of the Port to do otherwise;
    (ii) Commercial vessels operating at waterfront facilities located
within the zone;
    (iii) Vessels providing direct operational support to commercial
vessels within a moving security zone;
    (iv) Vessels operated by Federal, State, county, or municipal law
enforcement agencies.
    (3) Meeting, crossing or overtaking situations are not permitted
within the security zone described in paragraph (a)(2) of this section
unless specifically authorized by the Captain of the Port.
    (4) Other persons or vessels requiring entry into security zones
described in this section must request permission from the Captain of
the Port, Port Arthur or designated representative.
    (5) To request permission to enter a security zone described in
this section, contact Vessel Traffic Service Port Arthur on VHF Channel
01A or 65A; by telephone at<PHONE_NUMBER>; by fax at<PHONE_NUMBER>;
or contact the Captain of the Port's designated on-scene patrol vessel
on VHF channel 13 or 16.
    (6) All persons and vessels within a security zone described in
this section must comply with the instructions of the Captain of the
Port, Port Arthur, designated on-scene U.S. Coast Guard patrol
personnel or other designated representatives. Designated on-scene U.S.
Coast Guard patrol personnel include commissioned, warrant, and petty
officers of the U.S. Coast Guard. Designated representatives include
Federal, State, local and municipal law enforcement agencies.

    Dated: August 23, 2010.
J.J. Plunkett,
Captain, U.S. Coast Guard, Captain of the Port, Port Arthur.
[FR Doc. 2010-26670 Filed 10-21-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 237 (Tuesday, December 14, 2021)]
[Rules and Regulations]
[Pages 70980-70982]
[FR Doc No: 2021-26846]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0577; FRL-9216-01-OCSPP]

Kosakonia cowanii strain SYM00028; Exemption From the Requirement
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Kosakonia cowanii strain SYM00028 in or
on all food commodities when used in accordance with label directions
and good agricultural practices. Indigo Ag, Inc., submitted a petition
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of Kosakonia cowanii strain SYM00028 under FFDCA when used
in accordance with this exemption.

DATES: This regulation is effective December 14, 2021. Objections and
requests for hearings must be received on or before February 14, 2022
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0577, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
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 Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room are closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2020-0577 in the subject line on the first
page of your submission. All objections and requests for a hearing

must be in writing and must be received by the Hearing Clerk on or
before February 14, 2022. Addresses for mail and hand delivery of
objections and hearing requests are provided in 40 CFR 178.25(b),
although EPA strongly encourages those interested in submitting
objections or a hearing request to submit objections and hearing
requests electronically. See Order Urging Electronic Service and Filing
(April 10, 2020), https://www.epa.gov/sites/production/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
At this time, because of the COVID-19 pandemic, the judges and staff of
the Office of Administrative Law Judges are working remotely and not
able to accept filings or correspondence by courier, personal delivery,
or commercial delivery, and the ability to receive filings or
correspondence by U.S. Mail is similarly limited. When submitting
documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a
person should utilize the OALJ e-filing system at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf.
    Although EPA's regulations require submission via U.S. Mail or hand
delivery, EPA intends to treat submissions filed via electronic means
as properly filed submissions during this time that the Agency
continues to maximize telework due to the pandemic; therefore, EPA
believes the preference for submission via electronic means will not be
prejudicial. If it is impossible for a person to submit documents
electronically or receive service electronically, e.g., the person does
not have any access to a computer, the person shall so advise OALJ by
contacting the Hearing Clerk at<PHONE_NUMBER>. If a person is without
access to a computer and must file documents by U.S. Mail, the person
shall notify the Hearing Clerk every time it files a document in such a
manner. The address for mailing documents is U.S. Environmental
Protection Agency, Office of Administrative Law Judges, Mail Code
1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0577, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background

    In the Federal Register of February 24, 2021 (86 FR 11215) (FRL-
10019-68), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
exemption petition (PP 0F8845) by Indigo Ag, Inc., 500 Rutherford Ave.,
Ste. 201, Boston, MA 02129. The petition requested that 40 CFR part 180
be amended by establishing an exemption from the requirement of a
tolerance for residues of the fungicide Kosakonia cowanii strain
SYM00028 in or on all food commodities. That notice referenced a
summary of the petition prepared by the petitioner Indigo Ag, Inc., and
available in the docket via https://www.regulations.gov. No comments
were received on the notice of filing.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance or tolerance exemption and
to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .'' Additionally, FFDCA section 408(b)(2)(D)
requires that EPA consider ``available information concerning the
cumulative effects of [a particular pesticide's] . . . residues and
other substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicological and exposure data on
Kosakonia cowanii strain SYM00028 and considered their validity,
completeness, and reliability, as well as the relationship of this
information to human risk. A full explanation of the data upon which
EPA relied and its risk assessment based on those data can be found
within the document entitled ``Product Chemistry Review and Human
Health Risk Assessment for the Section 3 Registration Submitted by
Indigo Ag Inc., (EP Indigo 229 FP/WD) Containing the New Active
Ingredient Kosakonia cowanii strain SYM00028'' (Kosakonia cowanii
strain SYM00028 Human Health Assessment). This document, as well as
other relevant information, is available in the docket for this action
as described under ADDRESSES.
    The available data demonstrated that, with regard to humans,
Kosakonia cowanii strain SYM00028 is not toxic via the pulmonary
(LC50 > 5.21 mg/L), oral (LD50 > 5,000 mg/kg
bodyweight), or dermal (LD50 > 5,050 mg/kg bodyweight)
routes of exposure; is not toxic, pathogenic, or infective via the
injection route of exposure when administered intravenously at a
nominal dose of 2.43 x 10\7\ colony-forming units per test animal; is
not anticipated to be pathogenic or infective via the oral or pulmonary
routes of exposure; and is slightly irritating via the dermal route of
exposure. Additionally, the acute injection toxicity/pathogenicity
study demonstrated a pattern of clearance of Kosakonia cowanii strain
SYM00028 from the blood and organs of the test animals. Significant
dietary and non-occupational exposures to residues of Kosakonia cowanii
strain SYM00028 are not anticipated because it will be used only as a
seed treatment and it is not expected to remain at high levels on plant
surfaces or readily percolate through soil. Even if dietary and non-
occupational exposures to residues of Kosakonia cowanii strain SYM00028
were to occur, there is not a concern due

to the lack of potential for adverse effects. Because there are no
threshold levels of concern with the toxicity, pathogenicity, or
infectivity of Kosakonia cowanii strain SYM00028, EPA determined that
no additional margin of safety is necessary to protect infants and
children as part of the qualitative assessment conducted. Based upon
its evaluation in the Kosakonia cowanii strain SYM00028 Human Health
Assessment, which concludes that there are no risks of concern from
aggregate exposure to Kosakonia cowanii strain SYM00028, EPA concludes
that there is a reasonable certainty that no harm will result to the
U.S. population, including infants and children, from aggregate
exposure to residues of Kosakonia cowanii strain SYM00028.

B. Analytical Enforcement Methodology

    An analytical method is not required for Kosakonia cowanii strain
SYM00028 because EPA is establishing an exemption from the requirement
of a tolerance without any numerical limitation.

C. Conclusion

    Therefore, an exemption from the requirement of a tolerance is
established for residues of Kosakonia cowanii strain SYM00028 in or on
all food commodities when used in accordance with label directions and
good agricultural practices.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to EPA. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this action, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601
et seq.) do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA has determined that this
action will not have a substantial direct effect on States or Tribal
Governments, on the relationship between the National Government and
the States or Tribal Governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian Tribes. Thus, EPA has determined that
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (2 U.S.C.
1501 et seq.).
    This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: December 6, 2021.
Edward Messina,
Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.1387 to subpart D to read as follows:

Sec.  180.1387  Kosakonia cowanii strain SYM00028; exemption from the
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of Kosakonia cowanii strain SYM00028 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.

[FR Doc. 2021-26846 Filed 12-13-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Pages 55954-55956]
[FR Doc No: 2011-23034]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65246; File No. SR-NASDAQ-2011-120]

Self-Regulatory Organizations; the NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Modify Fees for Members Using the NASDAQ Market Center

September 1, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on August 25, 2011, The NASDAQ Stock Market LLC (the ``Exchange''
or ``NASDAQ'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III, below, which Items have been prepared by NASDAQ. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    NASDAQ proposes to modify pricing for NASDAQ members using the
NASDAQ Market Center. NASDAQ will implement the proposed change on
September 1, 2011. The text of the proposed rule change is available at
http://nasdaq.cchwallstreet.com/, at NASDAQ's principal office, at the
Commission's Public Reference Room, and at the Commission's Web site at
http://www.sec.gov.

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

    In its filing with the Commission, NASDAQ 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. NASDAQ 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    NASDAQ is amending Rule 7018 to make two modifications to its
pricing schedule for routing and execution of quotes/orders through the
NASDAQ Market Center of securities priced at $1 or more. First, NASDAQ
is proposing to extend and modify, for one month the Attributable
Market Provider pilot program to continue to encourage more extensive
market making activity on NASDAQ. Under the pilot, set forth in NASDAQ
Rule 7018(a)(4), a market maker with an MPID through which it has
registered as a market maker in a daily average of more than 5,000
securities during the month will receive an additional credit of
$0.0004 per share executed with respect to attributable quotes/orders
that provide liquidity through such MPID, in addition to the credit
that it is otherwise entitled to receive under Rule 7018. Currently,
the maximum additional rebate that a member can receive under this
pilot program is $250,000 per month. NASDAQ is reducing the maximum
from $250,000 to $100,000 during the one-month extension of the pilot.
    The cap applies on a per member basis, regardless of the number of
MPIDs through which the member qualifies for the program. Through the
program, NASDAQ hopes to see a continuation of increased market maker
participation and contribution of attributable liquidity in order to
enhance price discovery. Throughout the pilot period, NASDAQ will
evaluate the costs and benefits of the program, and will then either
allow the pilot to lapse or file to extend, modify, or make the program
permanent.
    Second, NASDAQ is raising from $0.0027 to $0.0029 the charge for
members entering Directed Orders sent to NASDAQ OMX PSX. The current
charge of $0.0027 reflects a premium of $0.0002 above the standard
charge for removing liquidity at NASDAQ OMX PSX. Effective September 1,
2011, NASDAQ OMX PSX will be increasing by $0.0002 the charge for
removing liquidity. Therefore, to maintain the $0.0002 premium above
that rate, NASDAQ is increasing the rate for Directed Orders sent to
NASDAQ OMX PSX by $0.0002 to $0.0029.
2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\3\ in general, and with Section
6(b)(4) of the Act,\4\ in particular, in that it provides for the
equitable allocation of reasonable dues, fees and other charges among
members and issuers and other persons using any facility or system
which NASDAQ operates or controls. All similarly situated members are
subject to the same fee structure, and access to NASDAQ is offered on
fair and non-discriminatory terms.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f.
    \4\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    Extending the proposed Attributable Market Provider program is
reasonable because it will continue a fee reduction for members that
qualify for the program, without increasing the costs borne by other
members. It is reasonable that NASDAQ lowers the maximum credit due to
its analysis of the current mix of usage of the pilot program by its
various members. Moreover, the proposed program is consistent with an
equitable allocation of fees because it allocates a higher rebate to
members that make significant contributions to NASDAQ market quality by
making markets in a large number of stocks and that contribute to price
discovery by posting attributable quotes/orders. Although members
qualifying for the program may use non-attributed and non-displayed
orders, the enhanced rebate will be paid only with respect to
attributable, displayed liquidity. Based on three months of experience
with the pilot, NASDAQ believes that the program does encourage some
market makers to become active in more stocks and display more shares
of liquidity, thereby benefiting other market participants that will
receive a more complete understanding of the supply and demand for
particular stocks and that will be able to access the liquidity
displayed by such market makers.
    With respect to the charge for sending Directed Orders to NASDAQ
OMX PSX, NASDAQ believes that raising the fee by $0.0002 is reasonable
and an equitable allocation of fees in that this increase maintains a
stable premium of $0.0002 over the charge for removing liquidity on
NASDAQ OMX PSX. This premium represents a fee for usage of NASDAQ's
state-of-the-art routing service.
    Finally, NASDAQ notes that it operates in a highly competitive
market in which market participants can readily favor competing venues
if they deem fee levels at a particular venue to be excessive. In such
an environment, NASDAQ must continually adjust its fees to remain
competitive with other exchanges and with alternative trading systems
that have been exempted from compliance with the statutory standards
applicable to exchanges.

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

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended. Because the market
for order execution and routing is extremely competitive, members may
readily opt to disfavor NASDAQ's execution services if they believe
that alternatives offer them better value. For this reason and the
reasons discussed in connection with the statutory basis for the
proposed rule change, NASDAQ does not believe that the proposed changes
will impair the ability of members or competing order execution venues
to maintain their competitive standing in the financial markets.

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

    Written comments were neither solicited nor received.

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)(A)(ii) of the Act.\5\ At any time within 60 days of the filing
of the proposed rule change, the Commission summarily may temporarily
suspend such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(3)(a)(ii).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File

Number SR-NASDAQ-2011-120 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-NASDAQ-2011-120. 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 Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of the filing also will be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; 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-
NASDAQ-2011-120 and should be submitted on or before September 30,
2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(12).
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    Dated: September 1, 2011
Elizabeth M. Murphy
Secretary
[FR Doc. 2011-23034 Filed 9-8-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 46 (Friday, March 8, 2019)]
[Notices]
[Pages 8532-8533]
[FR Doc No: 2019-04241]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1543]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Proposed Suffix for the Proper Name of a Biological
Product

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on Proposed Suffix for the Proper Name of a
Biological Product.

DATES: Submit either electronic or written comments on the collection
of information by May 7, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 7, 2019. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-D-1543 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Proposed Suffix for the Proper
Name of a Biological Product.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.

    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Proposed Suffix for the Proper Name of a Biological Product

OMB Control Number 0910--New

    The final guidance for industry, ``Nonproprietary Naming of
Biological Products,'' proposes a new collection of information by
recommending that applicants propose a suffix composed of four
lowercase letters to be included in the ``proper name.'' The ``proper
name'' is designated by FDA at the time of licensure for biological
products submitted under section 351(a) of the Public Health Service
Act (PHS Act) (42 U.S.C. 262(a)) and for biosimilar products and
interchangeable products submitted under section 351(k) of the PHS Act.
The guidance recommends an applicant submit up to 10 proposed suffixes
and include any analyses of how the proposed suffixes meet the factors
described in the final guidance for industry. FDA's evaluation will
generally occur during the investigational new drug application phase
and will also be incorporated into the review of the marketing
application.
    FDA previously published a 60-day notice in the Federal Register of
August 28, 2015 (80 FR 52296), and a 30-day notice in the Federal
Register of January 13, 2017 (82 FR 4345), on this proposed collection
of information. OMB did not reach a decision on this collection of
information, withdrawing it on July 3, 2018. Consistent with the
revisions proposed in the draft guidance, entitled ``Nonproprietary
Naming of Biological Products--Update,'' FDA is re-initiating the
notice and comment process for this collection of information,
beginning with this 60-day notice.
    Published elsewhere in this issue of the Federal Register, FDA is
announcing the availability of a draft guidance for industry entitled
``Nonproprietary Naming of Biological Products: Update.'' This draft
guidance proposes to amend the final guidance, ``Nonproprietary Naming
of Biological Products.'' The draft guidance describes, among other
things, FDA's current thinking on nonproprietary (proper) names of
biological products licensed under section 351 of the PHS Act that do
not include an FDA-designated suffix. Specifically, the proper names of
these products need not be revised in order to accomplish the
objectives of the naming convention described in the final guidance for
industry, ``Nonproprietary Naming of Biological Products, '' dated
January 2017. This draft guidance is not intended to be finalized.
Based on the comments received on this draft guidance, FDA intends to
revise the final guidance, ``Nonproprietary Naming of Biological
Products, '' dated January 2017, and to amend sections, such as
sections IV.D and V.B in that document, regarding the subjects
addressed in this draft guidance.
    Consistent with the Draft Guidance, FDA proposes to gather the same
type of information contemplated by the withdrawn information
collection request (80 FR 52269 and 82 FR 4345). Due to the revisions
proposed in the draft guidance, however, FDA anticipates that the
number of respondents will be reduced, and FDA has re-estimated the
burden of the collection of information accordingly. The proposed
collection of information described in this notice is a new collection
of information only and does not include a modification of an existing
collection of information as previously recommended as part of the 60-
day (80 FR 52296) and 30-day (82 FR 4345) notices of the Federal
Register.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Information for the Proposed                  15               1              15             420           6,300
 Proper Name for Applicable
 Biological Products Submitted
 Under Section 351(a) of the PHS
 Act............................
Information for the Proposed                   9               1               9             420           3,780
 Proper Name for Applicable
 Biological Products Submitted
 Under Section 351(k) of the PHS
 Act............................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          10,080
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    As indicated in table 1 above, we estimate that we will receive a
total of approximately 15 requests annually for the proposed ``proper
name'' for biological products submitted under section 351(a) of the
PHS Act and 9 requests annually for the proposed ``proper name'' for
biosimilar products and interchangeable products submitted under
section 351(k) of the PHS Act. The estimated total annual responses are
based on data from user fee rates for fiscal year 2019. The number of
responses per respondent has been updated to reflect FDA's most recent
information on the number of applications that are expected to be
submitted under 351 of the PHS Act to the Agency annually. The average
burden per response (hours) is based on FDA's consideration of comments
received in response to the 60-day and 30-day notices requesting public
comment on the withdrawn information collection request associated with
the final guidance (80 FR 52269 and 82 FR 4345).

    Dated: March 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04241 Filed 3-7-19; 8:45 am]
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