[Federal Register Volume 83, Number 159 (Thursday, August 16, 2018)]
[Rules and Regulations]
[Pages 40679-40681]
[FR Doc No: 2018-17697]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0683]
RIN 1625-AA00

Safety Zone; Great Lakes Offshore Grand Prix, Lake Erie, Dunkirk,
NY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of Dunkirk Harbor, Lake Erie, Dunkirk, NY. This safety
zone is intended to restrict vessels from portions of Dunkirk Harbor
during the Great Lakes Offshore Grand Prix. This temporary safety zone
is necessary to protect mariners and vessels from the navigational
hazards associated with this regatta. Entry of vessels or persons into
this zone is prohibited unless specifically authorized by the Captain
of the Port Buffalo.

DATES: This rule is effective from 10:00 a.m. on August 18, 2018 until
5:00 p.m. on August 19, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-0683 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LTJG Sean Dolan, Chief of Waterways Management, U.S.
Coast Guard Sector Buffalo; telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On March 22, 2018, Dunkirk Local Development Corporation and
Dunkirk Festivals notified the Coast Guard that it will conducting a
professional high speed powerboat race from 10:00 a.m. until 5:00 p.m.
on August 19, 2018. In response, on July 23, 2018, the Coast Guard
published a notice of proposed rulemaking (NPRM) titled ``Great Lakes
Offshore Grand Prix; Lake Erie, Dunkirk, NY'' (83 FR 34804, July 23,
2018). There we stated why we issued the NPRM, and invited comments on
our proposed regulatory action related to this event. During the
comment period that ended August 7, 2018, we received no comments.
    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. Delaying the effective date would
be contrary to the rule's objectives of ensuring safety of life on the
navigable waters and protection of persons and vessels in the vicinity
of the planned event.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Buffalo (COTP) has determined the Great
Lakes Offshore Grand Prix presents significant risks to the public
safety and property. This rule is needed to protect personnel, vessels,
and the marine environment in the navigable waters within the safety
zone while the event takes place.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received no comments on our NPRM published July
23, 2018. There are no changes in the regulatory text of this rule from
the proposed rule in the NPRM.
    This rule establishes a safety zone from 10:00 a.m. until 5:00 p.m.
on August 19, 2018, with a rain date of August 18, 2018. The safety
zone will encompass all navigable waters of Lake Erie, Dunkirk, NY
starting at position 42[deg]29'37.7'' N, 079[deg]21'17.7'' W then
Northwest to 42[deg]29'45.2'' N, 079[deg]21'28.2'' W then Northeast to
42[deg]30'15.0'' N, 079[deg]21'20.0'' W then Northeast to
42[deg]30'39.0'' N, 079[deg]19'46.0'' W then Southeast to
42[deg]30'09.3'' N, 079[deg]19'03.1'' W. The duration of the zone is
intended to enhance the safety of vessels and these navigable waters
before, during, and after the scheduled 10:00 a.m. until 5:00 p.m. boat
races.
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Buffalo or his
designated on-scene representative. The Captain of the Port or his
designated on-scene representative may be contacted via VHF Channel 16.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses

based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the conclusion
that this rule is not a significant regulatory action. Vessel traffic
will be able to safely transit around this safety zone, which impacts a
small designated area of Dunkirk Harbor. The event will also have built
in times where vessels will be able to transit through the safety zone
during breaks. Moreover, the Coast Guard will issue a Broadcast Notice
to Mariners via VHF-FM marine channel 16 about the zone, and the rule
will allow vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received 00 comments from the Small Business
Administration on this rulemaking. 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.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    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.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this 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. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have determined that 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
establishes a temporary safety zone. It is categorically excluded from
further review under paragraph L60 (a) of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental
Consideration supporting this determination is available in the docket
where indicated under ADDRESSES.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

    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: Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR
1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T09-0683 to read as follows:

Sec.  165.T09-0683  Safety Zone; Great Lakes Offshore Grand Prix; Lake
Erie, Dunkirk, NY.

    (a) Location. The safety zone will encompass all waters of Lake
Erie,

Dunkirk, NY starting at position 42[deg] 29'37.7'' N, 079[deg]
21'17.7'' W then Northwest to 42[deg] 29'45.2'' N, 079[deg] 21'28.2'' W
then Northeast to 42[deg] 30'15.0'' N, 079[deg] 21'20.0'' W then
Northeast to 42[deg]30'39.0'' N, 079[deg] 19'46.0'' W then Southeast to
42[deg] 30'09.3'' N, 079[deg] 19'03.1'' W.
    (b) Enforcement period. This rule is effective from 10:00 a.m.
until 5:00 p.m. on August 19, 2018 with a rain date of August 18, 2018.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry into, transiting, or anchoring within this safety
zone is prohibited unless authorized by the Captain of the Port Buffalo
or his designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Buffalo or his designated on-
scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port
Buffalo is any Coast Guard commissioned, warrant or petty officer who
has been designated by the Captain of the Port Buffalo to act on his
behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone must contact the Captain of the Port Buffalo or his on-scene
representative to obtain permission to do so. The Captain of the Port
Buffalo or his on-scene representative may be contacted via VHF Channel
16. Vessel operators given permission to enter or operate in the safety
zone must comply with all directions given to them by the Captain of
the Port Buffalo, or his on-scene representative.

    Dated: August 13, 2018.
Kenneth E. Blair,
Commander, U.S. Coast Guard, Acting Captain of the Port Buffalo.
[FR Doc. 2018-17697 Filed 8-15-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Pages 45247-45249]
[FR Doc No: 2018-19249]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3130]

Consideration of Uncertainty in Making Benefit-Risk
Determinations in Medical Device Premarket Approvals, De Novo
Classifications, and Humanitarian Device Exemptions; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Consideration of
Uncertainty in Making Benefit-Risk Determinations in Medical Device
Premarket Approvals, De Novo Classifications, and Humanitarian Device
Exemptions.'' This guidance document describes FDA's current approach
to considering uncertainty in making benefit-risk determinations to
support certain FDA premarket decisions for medical devices--premarket
approval applications (PMAs), De Novo requests, and humanitarian device
exemption (HDE) applications. This guidance document elaborates on the
consideration of uncertainty as part of our overarching approach to a
benefit-risk based framework that is intended to assure greater
predictability, consistency, and efficiency through the application of
least burdensome principles. This draft guidance also provides examples
of how the principles for considering uncertainty could be applied in
the context of clinical evidence and circumstances where greater
uncertainty could be appropriate in premarket decisions, balanced by
postmarket controls--PMAs for Breakthrough Devices and PMAs for devices
for small patient populations. This draft guidance is not final nor is
it in effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by December 5, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

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-2018-D-3130 for ``Consideration of Uncertainty in Making Benefit-
Risk Determinations in Medical Device Premarket Approvals, De Novo
Classifications, and Humanitarian Device Exemptions; Draft Guidance for
Industry and Food and Drug Administration Staff.'' Received comments
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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Consideration of Uncertainty in Making Benefit-Risk Determinations in
Medical Device Premarket Approvals, De Novo Classifications, and
Humanitarian Device Exemptions'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Sonja Fulmer, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5451, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Medical Device Amendments of 1976 (Pub. L. 94-295) to the
Federal Food, Drug, and Cosmetic Act (FD&C Act) established a risk-
based framework for the regulation of medical devices. The law
established a three-tiered risk classification system based on the risk
posed to patients should the device fail to perform as intended. Under
this system, devices that pose greater risks to patients are subject to
more regulatory controls and requirements. Generally, in premarket
decision-making for devices, there exists some uncertainty around
benefits and risks. The Agency generally provides marketing
authorization for a device when it meets the applicable standards,
including that its benefits outweigh its risks.
    In 2015, following pilots conducted over 4 years, FDA established
the Expedited Access Pathway Program as a voluntary program for certain
medical devices that address an unmet need in the treatment or
diagnosis of life-threatening or irreversibly debilitating diseases or
conditions. Under this program, an eligible device subject to a PMA
could be approved with greater uncertainty about the product's benefits
and risks, provided that, among other requirements, the data still
support a reasonable assurance of safety and effectiveness, including
that the probable benefits of the device outweigh its risks for a
patient population with unmet medical needs. For devices subject to
PMA, the Agency has the authority to impose, when warranted, postmarket
requirements, including post-approval studies and postmarket
surveillance, as a condition of approval, which could be used to
address this greater uncertainty.\1\ In the Breakthrough Device
provisions of the FD&C Act, as added by the 21st Century Cures Act
(Cures Act) and amended by the FDA Reauthorization Act of 2017 (FDARA),
Congress codified and expanded this program to include devices reviewed
through a 510(k) notification.\2\
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    \1\ See sections 513(a)(3)(C), 515(c)(5)(C), 515(d)(1)(B)(ii),
and 515B(e)(2)(C) of the FD&C Act (21 U.S.C. 360c(a)(3)(C),
360e(c)(5)(C), 360e(d)(1)(B)(ii), and 360e-3(e)(2)(C)); 21 CFR
814.82).
    \2\ See section 515B of the FD&C Act (21 U.S.C. 360e-3), as
created by section 3051 of the Cures Act (Pub. L. 114-255) and
amended by section 901 of FDARA (Pub. L. 115-52).
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    This draft guidance provides further information on how FDA
considers uncertainty in benefit-risk determinations for PMAs, De Novo
requests, and HDE applications.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on consideration
of uncertainty in making benefit-risk determinations in medical device
premarket approvals, De Novo classifications, and humanitarian device
exemptions. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Consideration of
Uncertainty in Making Benefit-Risk Determinations in Medical Device
Premarket Approvals, De Novo Classifications, and Humanitarian Device
Exemptions; Draft Guidance for Industry and Food and Drug
Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 17039 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 801 have been approved under
OMB control number 0910-0485; the collections of information for De
Novo classification requests have been approved under OMB control
number 0910-0844; the collections of information in 21 CFR part 814,
subparts A through E, have been approved under OMB control number 0910-
0231; the collections of information in 21 CFR part 814, subpart H,
have been approved under OMB control number 0910-0332; and the
collections of information in 21 CFR

part 822 have been approved under OMB control number 0910-0449.

    Dated: August 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19249 Filed 9-5-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27478-27479]
[FR Doc No: 2017-12391]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC17-129-000.
    Applicants: Virginia Electric and Power Company.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act and Requests for Waivers, Shortened Comment Period
and Expedited Consideration of Virginia Electric and Power Company.
    Filed Date: 6/9/17.
    Accession Number: 20170609-5141.
    Comments Due: 5 p.m. ET 6/30/17.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER17-1782-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) Rate Filing: 2017-06-09 Amended and
Restated Participating Generator Agreement Energia Azteca to be
effective 8/9/2017.
    Filed Date: 6/9/17.
    Accession Number: 20170609-5081.
    Comments Due: 5 p.m. ET 6/30/17.

    Docket Numbers: ER17-1783-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Sec.  205(d) Rate Filing: DEC RS Nos. 315, 316, 317
and 335 Revised PPA Filing to be effective 7/1/2017.
    Filed Date: 6/9/17.
    Accession Number: 20170609-5082.
    Comments Due: 5 p.m. ET 6/30/17.

    Docket Numbers: ER17-1784-000.
    Applicants: NRG Delta LLC.
    Description: Tariff Cancellation: Notice of Cancellation to be
effective 6/10/2017.
    Filed Date: 6/9/17.
    Accession Number: 20170609-5099.
    Comments Due: 5 p.m. ET 6/30/17.

    Docket Numbers: ER17-1785-000.
    Applicants: Coachella Wind, LLC.
    Description: Baseline eTariff Filing: MBR Application to be
effective 12/31/9998.
    Filed Date: 6/9/17.
    Accession Number: 20170609-5109.
    Comments Due: 5 p.m. ET 6/30/17.

    Docket Numbers: ER17-1786-000.
    Applicants: SWG Arapahoe, LLC.
    Description: Sec.  205(d) Rate Filing: Changes to Market Based Rate
Tariff to be effective 6/12/2017.
    Filed Date: 6/9/17.
    Accession Number: 20170609-5117.
    Comments Due: 5 p.m. ET 6/30/17.

    Docket Numbers: ER17-1787-000.
    Applicants: Innovative Solar 37, LLC.
    Description: Compliance filing: Notice of Change in Status and
Amendment to Tariff to be effective 5/11/2017.
    Filed Date: 6/9/17.
    Accession Number: 20170609-5127.
    Comments Due: 5 p.m. ET 6/30/17.

    Docket Numbers: ER17-1788-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) Rate Filing: 2017-06-07 Pre-RA Import
Commitment Definition Modification Amendment to be effective 7/10/2017.
    Filed Date: 6/9/17.

    Accession Number: 20170609-5128.
    Comments Due: 5 p.m. ET 6/30/17.

    Docket Numbers: ER17-1789-000.
    Applicants: Interstate Power and Light Company.
    Description: Sec.  205(d) Rate Filing: IPL Changes in Depreciation
Rates for Wholesale Production Service to be effective 8/8/2017.
    Filed Date: 6/9/17.
    Accession Number: 20170609-5132.
    Comments Due: 5 p.m. ET 6/30/17.

    Docket Numbers: ER17-1790-000.
    Applicants: United Energy Trading, LLC.
    Description: Baseline eTariff Filing: Application for Market Based
Rate to be effective 8/8/2017.
    Filed Date: 6/9/17.
    Accession Number: 20170609-5134.
    Comments Due: 5 p.m. ET 6/30/17.

    Docket Numbers: ER17-1791-000.
    Applicants: Fountain Valley Power, L.L.C.
    Description: Sec.  205(d) Rate Filing: Changes to Market Based Rate
Tariff to be effective 6/12/2017.
    Filed Date: 6/9/17.
    Accession Number: 20170609-5136.
    Comments Due: 5 p.m. ET 6/30/17.

    Docket Numbers: ER17-1792-000.
    Applicants: SWG Colorado, LLC.
    Description: Sec.  205(d) Rate Filing: Changes to Market Based Rate
Tariff to be effective 6/12/2017.
    Filed Date: 6/9/17.
    Accession Number: 20170609-5137.
    Comments Due: 5 p.m. ET 6/30/17.

    Docket Numbers: ER17-1793-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2017-06-09_HVDC Attachment X
Filing to be effective 6/16/2017.
    Filed Date: 6/9/17.
    Accession Number: 20170609-5139.
    Comments Due: 5 p.m. ET 6/30/17.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF17-673-000.
    Applicants: Beaver Creek Wind II, LLC.
    Description: Response of Beaver Creek Wind II, LLC to May 10, 2017
Deficiency Letter.
    Filed Date: 6/9/17.
    Accession Number: 20170609-5124.
    Comments Due: 5 p.m. ET 6/9/17.

    Docket Numbers: QF17-674-000.
    Applicants: Beaver Creek Wind III, LLC.
    Description: Response of Beaver Creek Wind III, LLC to May 10, 2017
Deficiency Letter.
    Filed Date: 6/9/17.
    Accession Number: 20170609-5123.
    Comments Due: 5 p.m. ET 6/9/17.

    Take notice that the Commission received the following PURPA
210(m)(3) filings:

    Docket Numbers: QM17-5-000.
    Applicants: East Kentucky Power Cooperative, Inc.
    Description: Application to Terminate Mandatory PURPA Purchase
Obligation of East Kentucky Power Cooperative, Inc.
    Filed Date: 6/9/17.
    Accession Number: 20170609-5119.
    Comments Due: 5 p.m. ET 7/7/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 9, 2017 .
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-12391 Filed 6-14-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)]
[Notices]
[Pages 10619-10620]
[FR Doc No: 2016-04451]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9942-97-OA]

Notification of a Public Meeting of the Chartered Science
Advisory Board

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) Science Advisory
Board (SAB) Staff Office announces a public meeting of the chartered
SAB to: (1) Conduct a quality review of a draft SAB report on an
accounting framework for biogenic carbon dioxide emissions; (2) discuss
information provided by the EPA on planned actions in the Fall 2015
semi-annual regulatory agenda and their supporting science; and (3)
receive briefings from the EPA Office of Research and Development and
the Office of the Science Advisor.

DATES: The public meeting will be held on Thursday, March 31, 2016,
from 1:30 p.m. to 5:00 p.m. and Friday April 1, 2016, from 9:00 a.m. to
1:00 p.m.

ADDRESSES: The meeting will be held at the Westin Crystal City, 1800
Jefferson Davis Highway, Arlington, VA 22202.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wants
further information concerning the meeting may contact Mr. Thomas
Carpenter, Designated Federal Officer (DFO), EPA Science Advisory Board
(1400R), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue
NW., Washington, DC 20460; via telephone/voice mail<PHONE_NUMBER>, or
email at<EMAIL_ADDRESS>General information concerning the
SAB can be found on the EPA Web site at http://www.epa.gov/sab.

SUPPLEMENTARY INFORMATION:
    Background: The SAB was established pursuant to the Environmental
Research, Development, and Demonstration Authorization Act (ERDDAA),
codified at 42 U.S.C. 4365, to provide independent scientific and
technical advice to the Administrator on the scientific and technical
basis for Agency positions and regulations. The SAB is a Federal
Advisory Committee chartered under the Federal Advisory Committee Act
(FACA), 5 U.S.C., App. 2. The SAB will comply with the provisions of
FACA and all appropriate SAB Staff Office procedural policies. Pursuant
to FACA and EPA policy, notice is hereby given that the SAB will hold a
public meeting to discuss and deliberate on the topics below.

(1) Quality Review of a Draft SAB Review Report on the Framework for
Assessing Biogenic CO2 Emissions From Stationary Sources

    In 2012, the SAB completed a review of the first draft accounting
framework addressing scientific and technical issues associated with
biogenic carbon dioxide (CO2) emissions, Accounting
Framework for Biogenic CO2 Emissions from Stationary Sources (September
2011). The EPA subsequently revised the 2011 framework and requested
the SAB to conduct a review of the Framework for Assessing Biogenic CO2
Emissions from Stationary Sources (November 2014). The purpose of the
2014 framework is to develop a method for calculating the adjustment,
or Biogenic Assessment Factor (BAF), for carbon emissions associated
with the combustion of biogenic feedstocks taking into account the
biological carbon cycle effects associated with their growth, harvest
and processing. The SAB convened the Biogenic Carbon Emissions Panel to
review the framework.
    The chartered SAB will conduct a quality review of the panel's
draft report before it is transmitted to the EPA Administrator. The SAB
quality review process ensures that all draft reports developed by SAB
panels, committees or workgroups are reviewed and approved by the
Chartered SAB before being finalized and transmitted to the EPA
Administrator. These reviews are conducted in a public meeting as
required by FACA. Background on the current advisory activity, Biogenic
Carbon Dioxide Emissions from Stationary Sources--Assessment Framework
can be found on the SAB Web site at http://yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/Biogenic%20CO2%20Framework?OpenDocument.

(2) Discussion of Information in the Agency's Semiannual Regulatory
Agenda

    As part of the EPA's effort to routinely inform the SAB about
proposed and planned agency actions that have a scientific or technical
basis, the agency provided notice to the SAB that the Office of
Management and Budget published the ``Unified (Regulatory) Agenda'' on
the Web on November 20, 2015 available at http://www.reginfo.gov/public/do/eAgendaMain.
    The SAB convened a Work Group to review information provided in the
agency's Fall 2015 regulatory agenda regarding EPA planned actions and
their supporting science. The SAB will discuss recommendations and
information developed by the Work Group regarding the adequacy of the
science supporting the planned actions. Information about this advisory
activity can be found on the Web at http://yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/SAB%20Fall%202015%20Reg%20Agenda?OpenDocument.
    Availability of Meeting Materials: A meeting agenda and other
materials for the meeting will be placed on the SAB Web site at http://epa.gov/sab.
    Procedures for Providing Public Input: Public comment for
consideration by EPA's federal advisory committees and panels has a
different purpose from public comment provided to EPA program offices.
Therefore, the process for submitting comments to a federal advisory
committee is different from the process used to submit comments to an
EPA program office.
    Federal advisory committees and panels, including scientific
advisory committees, provide independent advice to the EPA. Members of
the public can submit relevant comments pertaining to the EPA's charge,
meeting materials, or the group providing advice. Input from the public
to the SAB will have the most impact if it provides specific scientific
or technical information or analysis for the SAB to consider or if it
relates to the clarity or accuracy of the technical information.
Members of the public wishing to provide comment should contact the DFO
directly.
    Oral Statements: In general, individuals or groups requesting an
oral presentation at a public meeting will be limited to five minutes.
Persons interested in providing oral statements at the March 31-April
1, 2016, meeting should contact Mr. Thomas Carpenter, DFO, in writing
(preferably via email) at the contact information noted above by March
23, 2016 to be placed on the list of registered speakers. Written
Statements: Written statements for the March 31-April 1, 2016, meeting
should be received in the SAB Staff Office by March 23, 2016, so that
the information can be made available to the SAB for its consideration
prior to the meeting. Written statements should be supplied

to the DFO at the contact information above via email (preferred) or in
hard copy with original signature. Submitters are requested to provide
a signed and unsigned version of each document because the SAB Staff
Office does not publish documents with signatures on its Web sites.
Members of the public should be aware that their personal contact
information, if included in any written comments, may be posted to the
SAB Web site. Copyrighted material will not be posted without explicit
permission of the copyright holder.
    Accessibility: For information on access or services for
individuals with disabilities, please contact Mr. Carpenter at the
phone number or email address noted above, preferably at least ten days
prior to the meeting, to give the EPA as much time as possible to
process your request.

    Dated: February 22, 2016.
Christopher Zarba,
Director, EPA Science Advisory Board Staff Office.
[FR Doc. 2016-04451 Filed 2-29-16; 8:45 am]
BILLING CODE 6560-50-P


                                                         UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                             WASHINGTON, D.C.  20460

 								 OFFICE OF POLICY

MEMORANDUM

SUBJECT:	Transmittal to Docket:  Documents from the March 21, 2011, Public Meeting in Boston, Massachusetts, regarding the Environmental Protection Agency's Implementation of Executive Order 13563:  Improving Regulation and Regulatory Review

FROM:	Stuart C. Miles-McLean 		Office of Regulatory Policy and Management

TO: 		Public Docket #EPA-HQ-OA-2011-0156:  Improving Regulations:  General                     As called for by President Obama in Executive Order 13563, "to facilitate the periodic review of existing significant regulations," the Environmental Protection Agency (EPA) is considering "how best to promote retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned."                As part of its retrospective review of regulations, EPA convened public meetings around the country to gather input on how we might design the plan we will use to periodically review our regulations.  This Memo transmits to the docket documents from the public meeting held on March 21, 2011, in Boston, Massachusetts.


[Federal Register Volume 84, Number 125 (Friday, June 28, 2019)]
[Rules and Regulations]
[Pages 30866-30868]
[FR Doc No: 2019-13605]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0648; Product Identifier 2017-SW-087-AD; Amendment
39-19670; AD 2019-12-15]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.A. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Leonardo S.p.A. (Leonardo) Model AB139 and AW139 helicopters. This AD
requires replacing screws installed on the left and right main landing
gear (MLG) shock absorber assembly. This AD was prompted by a report
that some screws may have been manufactured without meeting
specifications. We are issuing this AD to address the unsafe condition
on these products.

DATES: This AD is effective August 2, 2019.

ADDRESSES: For service information identified in this final rule,
contact Leonardo S.p.A. Helicopters, Matteo Ragazzi, Head of
Airworthiness, Viale G.Agusta 520, 21017 C.Costa di Samarate (Va)
Italy; telephone +39-0331-711756; fax +39-0331-229046; or at http://www.leonardocompany.com/-/bulletins. You may review the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0648; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the European Aviation Safety Agency (EASA) AD, the
regulatory evaluation, any comments received, and other information.
The address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: David Hatfield, Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Leonardo S.p.A.
Model AB139 and AW139 helicopters. The NPRM published in the Federal
Register on July 19, 2018 (83 FR 34072). The NPRM was prompted by a
report that some screws may have been manufactured without meeting
specifications. The NPRM proposed to require replacing screws installed
on the left and right MLG shock absorber assembly.
    We are issuing this AD to address an MLG shock absorber screw that
does not meet specifications. This condition could result in failure of
the MLG shock absorber, collapse or retraction of the MLG, and
subsequent damage to the helicopter.
    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2016-0077, dated April 19, 2016,
to correct an unsafe condition for Finmeccanica S.p.A. (previously
Agusta) Model AB139 and AW139 helicopters if equipped with kit
``Increased Gross Weight 6800 kg'' part number (P/N) 4G0000F00111
(kit). EASA advises of a manufacturing issue with the standard screws
(P/N NAS1351-5H12P) installed on MLG shock absorber assembly P/N
1652B0000-01. According to EASA, a material analysis shows that the MLG
shock absorber screws may have a lower fatigue life than the screws
used during the certification fatigue tests. EASA states the affected
MLG units have been identified by serial number (S/N). EASA also
advises that this unsafe condition, if not detected and corrected,
could result in failure of the MLG shock absorber, collapse or
retraction of the MLG, and subsequent damage to the helicopter and
injury to occupants.
    To correct this condition, the EASA AD requires replacing each
standard screw with a new screw P/N 1652A0001-01 and re-identifying the
S/N of each MLG shock absorber assembly that has the new screw
installed, and prohibits installing any affected MLG shock absorber
assembly unless the screw has been replaced.

Comments

    We gave the public the opportunity to participate in developing
this final rule, but we did not receive any comments on the NPRM.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to our bilateral agreement
with the European Union, EASA has notified us of the unsafe condition
described in the EASA AD. We are issuing this AD because we evaluated
all information provided by EASA and determined the unsafe condition
exists and is likely to exist or develop on other helicopters of these
same type designs and that air safety and the public interest require
adopting the AD requirements as proposed except for a minor editorial
change to meet current publishing requirements. In the Required Actions
paragraph, instances of ``Figure 1 to paragraph (a)'' have been changed
to ``Figure 1 to paragraphs (a) and (e)(2).'' This minor editorial
change is consistent with the intent of the proposals in the NPRM and
will not increase the economic burden on any operator nor increase the
scope of this AD.

Related Service Information

    We reviewed Finmeccanica Bollettino Tecnico No. 139-397, dated
April 7, 2016, which contains procedures for replacing the standard
screws installed on the left and right MLG assembly and for re-
identifying the MLG shock absorber assembly P/N and the MLG assembly S/
N.

Costs of Compliance

    We estimate that this AD affects 111 helicopters of U.S. Registry.
We estimate that operators may incur the following costs in order to
comply with this AD, based on an average labor rate of $85 per work-
hour.
    Replacing the screws on the left and right MLG assemblies requires
about 16

work-hours and $200 for parts, for a total cost of $1,560 per
helicopter and $173,160 for the U.S. fleet.
    According to Finmeccanica's service information, some of the costs
of this AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. We do not control warranty coverage by
Finmeccanica. Accordingly, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2019-12-15 Leonardo S.p.A.: Amendment 39-19670; FAA-2018-0648;
Product Identifier 2017-SW-087-AD.

(a) Applicability

    This AD applies to Leonardo S.p.A. Model AB139 and AW139
helicopters, certificated in any category, with an Increased Gross
Weight 6,800 Kg kit part number (P/N) 4G0000F00111, and with a main
landing gear (MLG) assembly with a P/N and serial number (S/N)
listed in Figure 1 to paragraphs (a) and (e)(2) of this AD
installed.
[GRAPHIC] [TIFF OMITTED] TR28JN19.001

(b) Unsafe Condition

    This AD defines the unsafe condition as an MLG shock absorber
screw that does not meet specifications. This condition could result
in failure of the MLG shock absorber, collapse or retraction of the
MLG, and subsequent damage to the helicopter.

(c) Effective Date

    This AD is effective August 2, 2019.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    (1) Within the following compliance times, replace each screw P/
N NAS1351-5H12P installed on an MLG shock absorber with a screw P/N
1652A0001-01. Re-identify the MLG assembly using black permanent ink
by marking an ``R'' at the end of the S/N of the MLG assembly and
cover with a transparent coating. For purposes of this AD, a
``landing'' is counted any time the helicopter lifts off into the
air and then lands again regardless of the duration of the landing
and regardless of whether the engine is shut down:
    (i) For MLG assemblies with 26,800 or more landings, within 100
hours time-in-service (TIS).
    (ii) For MLG assemblies with between 22,000 and 26,799 landings,
within 300 hours TIS or before the MLG assembly accumulates 27,200
landings, whichever occurs first.
    (iii) For MLG assemblies with less than 22,000 landings, within
1,200 hours TIS or before the MLG assembly accumulates 23,200
landings, whichever occurs first.

    (2) After the effective date of this AD, do not install an MLG
assembly with a P/N and S/N listed in Figure 1 to paragraphs (a) and
(e)(2) of this AD on any helicopter unless the screw has been
replaced and the MLG assembly re-identified as described in
paragraph (e)(1) of this this AD.

(f) Special Flight Permits

    Special flight permits are prohibited.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
David Hatfield, Aviation Safety Engineer, Safety Management Section,
Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth,
TX 76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(h) Additional Information

    (1) Finmeccanica Bollettino Tecnico No. 139-397, dated April 7,
2016, which is not incorporated by reference, contains additional
information about the subject of this AD. For service information
identified in this AD, contact Leonardo S.p.A. Helicopters, Matteo
Ragazzi, Head of Airworthiness, Viale G.Agusta 520, 21017 C.Costa di
Samarate (Va) Italy; telephone +39-0331-711756; fax +39-0331-229046;
or at http://www.leonardocompany.com/-/bulletins. You may review the
referenced service information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort
Worth, TX 76177.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency (EASA) AD No. 2016-0077, dated April 19, 2016. You may
view the EASA AD on the internet at http://www.regulations.gov in
Docket No. FAA-2018-0648.

 (i) Subject

    Joint Aircraft Service Component (JASC) Code: 3200, Landing Gear
System.

    Issued in Fort Worth, Texas, on June 19, 2019.
James A. Grigg,
Acting Deputy Director for Regulatory Operations, Compliance &
Airworthiness Division, Aircraft Certification Service.
[FR Doc. 2019-13605 Filed 6-27-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: January 24, 2011 (Volume 76, Number 15)]
[Notices]
[Page 4120-4121]
[DOCID:fr24ja11-65]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0620]

The National Antimicrobial Resistance Monitoring System Strategic
Plan 2011-2015; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for public comment of a document for The National
Antimicrobial Resistance Monitoring System (NARMS) entitled ``NARMS
Strategic Plan 2011-2015.'' The document outlines the strategic goals
and objectives for 2011 through 2015 of the NARMS program developed by
the participating Agencies (FDA, the Centers for Disease Control and
Prevention (CDC), and the United States Department of Agriculture
(USDA)) based on recommendations of an External Subcommittee of the
Science Board to FDA. The Agency is soliciting public comment on the
goals and objectives in the Strategic Plan and whether the goals and
objectives meet the recommendations of the subcommittee.

DATES: Submit either electronic or written comments by March 25, 2011.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Patrick McDermott, Center for
Veterinary Medicine (HFV-530), Food and Drug Administration, 8401
Muirkirk Rd., Laurel, MD 20708.<PHONE_NUMBER>. e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    NARMS is a national public health surveillance program that
monitors the susceptibility of enteric bacteria to antimicrobial agents
of medical importance. The NARMS program, established in 1996, is a
collaboration between FDA, CDC, USDA, and State and local health
departments. NARMS also has established collaborations with scientists
and surveillance systems monitoring antimicrobial resistance in other
countries.
    Foodborne diseases are an important cause of morbidity and
mortality worldwide. Travel, migration, and distribution of
contaminated food contribute to the problem of foodborne diseases. Non-
typhoidal Salmonella and Campylobacter are the leading bacterial causes
of foodborne illness in the United States and many countries. Each year
over two million people in the United States are infected with these
bacteria, resulting in tens of thousands of hospitalizations and
hundreds of deaths. Certain populations, such as young children (<5
years), the elderly, and the immunocompromised, are at higher risk for
infection. Most Salmonella and Campylobacter infections are self-
limited, but antimicrobial agents are essential to treat severe
illness. Antimicrobial resistance occurs among bacterial foodborne
pathogens and is recognized as a global public health hazard. NARMS
monitors antimicrobial susceptibility in enteric bacteria from humans,
retail meats, and food-producing animals. The human isolate component
of NARMS was initiated in 1996, and at that time tested only non-
typhoidal Salmonella and Escherichia coli O157 isolates. In 1997,
testing of Campylobacter isolates began, followed by Salmonella
serotype Typhi and Shigella in 1999. The animal component of NARMS
started in 1997, with monitoring of Salmonella isolated from chicken,
turkey, cattle, and swine carcasses, and later expanded to include
Campylobacter (1998), E. coli (2000), and Enterococcus (2003) isolated
from chicken carcasses. The retail meat component of NARMS started in
2002 with testing of Salmonella, Campylobacter, E. coli, and
Enterococcus isolates from meat commodities sold in retail stores.
    In addition to monitoring, NARMS conducts epidemiologic and
microbiologic research studies. Some studies examine risk factors and
clinical outcomes of infections with specific bacterial serotypes or
subsets of bacteria that exhibit particular resistance patterns. NARMS
research studies also focus on understanding the genetic mechanisms of
antimicrobial resistance in enteric bacteria and the mechanisms that
permit the transfer of resistance

between bacteria, on improving methods for isolation and typing, and on
developing new methods for antimicrobial susceptibility testing.
Additionally, NARMS examines enteric bacteria for genetic
interrelatedness using methods such as pulsed-field gel electrophoresis
(PFGE) and multilocus sequence typing. NARMS scientists enter PFGE
results into CDC's PulseNet database or USDA's VetNet database.
    In March 2007, an External Subcommittee of the Science Board to FDA
conducted a review of the NARMS program. This subcommittee made
recommendations related to four areas of work performed by NARMS: (1)
Sampling, (2) research, (3) international activities, and (4) data
management and reporting. Included in the report was a recommendation
to develop long-range strategic plans. In September 2008, NARMS held an
interagency planning meeting in Athens, GA to prioritize the Science
Board subcommittee's recommendations and implement measures to address
them. In August 2009, a second meeting was held in Rockville, MD to
report on progress, and to begin formulating the Strategic Plan that is
the subject of this notice.
    NARMS has established four strategic goals: (1) To develop,
implement, and optimize a shared database, with advanced data
acquisition, analysis, and reporting tools; (2) to make sampling more
representative and more applicable to trend analysis; (3) to strengthen
collaborative research projects; and (4) to support international
activities that promote food safety, especially those that promote
mitigation of the spread of antimicrobial-resistant bacteria and
resistance determinants. These four goals are discussed more fully in
the Strategic Plan and build on the progress made since NARMS'
inception, with special emphasis on the recommendations made by the FDA
Science Board subcommittee based on its review of the NARMS program in
2007.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/AnimalVeterinary/SafetyHealth/
AntimicrobialResistance/
NationalAntimicrobialResistanceMonitoringSystem/default.htm or http://
www.regulations.gov.

    Dated: January 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1278 Filed 1-21-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 168 (Friday, August 29, 2014)]
[Notices]
[Page 51637]
[FR Doc No: 2014-20414]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2014-61]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before September 18, 2014.

ADDRESSES: You may send comments identified by Docket Number FAA-2014-
0591 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jake Troutman,<PHONE_NUMBER>, 800
Independence Avenue SW., Washington, DC 20951.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on August 21, 2014.
James M. Crotty,
Acting Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2014-0591.
    Petitioner: Utility Aerial Services, Inc.
    Section of 14 CFR: Parts 21 subpart H, 27, 45.23(b), 45.27(a),
61.113(a) and (b), 91.9(b)(2), 91.7(a), 91.103, 91.109(a), 91.119,
91.121, 91.151(a), 91.203(a) and (b), 91.405(a), 91.407(a)(1),
91.409(a)(2), and 91.417(a) and (b).
    Description of Relief Sought: The petitioner is seeking an
exemption to commercially operate small unmanned aircraft systems
(sUAS) to perform utility-power generation inspections and patrols.

[FR Doc. 2014-20414 Filed 8-28-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 33 (Tuesday, February 21, 2017)]
[Notices]
[Pages 11248-11251]
[FR Doc No: 2017-03295]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80040; File No. SR-CBOE-2016-088]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Order Granting Approval of a Proposed Rule Change, as
Modified by Amendment No. 1, Related to the Nullification and
Adjustment of Options Transactions

February 14, 2017.

I. Introduction

    On December 14, 2016, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (the ``Act''),\1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to amend Exchange Rule 6.25,
relating to the adjustment and nullification of erroneous complex order
and stock-option order transactions. The proposed rule change was
published for comment in the Federal Register on January 3, 2017.\3\ On
February 13, 2017, the Exchange submitted Amendment No. 1 to the
proposed rule change.\4\ The Commission received no comments regarding
the proposal. This order approves the proposed rule change, as modified
by Amendment No. 1.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 79697 (December 27,
2016), 82 FR 167 (``Notice'').
    \4\ In Amendment No. 1, the Exchange proposed an implementation
date of April 17, 2017, to allow all the other options exchanges
that permit complex order or stock-option order transactions the
time necessary to harmonize their obvious error rules with the
proposed rule change. Because Amendment No. 1 does not materially
alter the substance of the proposed rule change or raise unique or
novel regulatory issues, Amendment No. 1 is not subject to notice
and comment. To promote transparency of its proposed amendment, when
CBOE filed Amendment No. 1 with the Commission, it also submitted
Amendment No. 1 as a comment letter to the file, which the
Commission posted on its Web site and placed in the public comment
file for SR-CBOE-2016-088 (available at https://www.sec.gov/comments/sr-cboe-2016-088/cboe2016088-1581994-131907.pdf). The
Exchange also posted a copy of its Amendment No. 1 on its Web site
(http://www.cboe.com/aboutcboe/legal/submittedsecfilings.aspx), when
it filed it with the Commission.
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II. Description of the Proposed Rule Change

    The Exchange proposes to amend Rule 6.25, entitled ``Nullification
and Adjustment of Options Transactions'' by adding Interpretation and
Policy .07 (a)-(c) related to the adjustment and nullification of
erroneous complex order and stock-option order transactions.

A. Background

    The Exchange and other options exchanges previously adopted new,
harmonized rules related to the adjustment and nullification of
erroneous options transactions.\5\ The Exchange believes that the
changes the options exchanges implemented with the new, harmonized rule
have led to increased transparency and finality with respect to the
adjustment and nullification of erroneous options transactions.
However, as part of the initial initiative, the Exchange and other
options exchanges deferred a few specific matters for further
discussion, including how erroneous complex orders and stock-option
orders should be handled.
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    \5\ See, e.g., Securities Exchange Act Release Nos. 74898 (May
7, 2015), 80 FR 27354 (May 13, 2015) (SR-CBOE-2015-039); and 74556
(March 20, 2015), 80 FR 16031 (March 26, 2015) (SR-BATS-2014-067)
(``BATS Order'').
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    Since the adopting of the initial harmonized rule, the exchanges
that offer complex orders and/or stock-option orders discussed the
adoption of a rule--described below--that they collectively believe
will improve the handling of erroneous options transactions that result
from the execution of complex orders and stock-option orders.\6\
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    \6\ See Notice, supra note 3, at 167. An exchange that does not
offer complex orders and/or stock-option orders will not adopt these
new provisions until such time as the exchange offers complex orders
and/or stock-option orders. See id. at 167 n.5.
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B. Proposed Rule

    The proposed rule applies much of the initial harmonized rule to
complex orders and stock-option orders. The proposed rule, however,
deviates from the initial harmonized rule to account for unique
qualities of complex orders and stock-option orders. Specifically, the
proposed rule reflects the fact that complex orders can execute against
other complex orders or can execute against individual simple orders in
the leg markets. When a complex order executes against the leg markets,
there may be different counterparties on each leg of the complex order,
and not every leg will necessarily be executed at an erroneous price.
With regards to stock-option orders, the proposed rule reflects the
fact that stock-option orders contain a stock component that is
executed on a stock trading venue, and the Exchange may not be able to
ensure that the stock trading venue will adjust or nullify the stock
execution in the event of an obvious or catastrophic error. In order to
account for the unique characteristics of complex orders and stock-
option orders,

the Exchange divided proposed Interpretation and Policy .07 into three
parts--paragraphs (a), (b), and (c).
1. Complex Orders Executed Against Individual Legs
    Proposed Interpretation and Policy .07(a) governs the review of
complex orders that are executed against individual legs (as opposed to
a complex order that executes against another complex order).\7\
Proposed Rule 6.25.07(a) provides:
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    \7\ The leg market consists of quotes and/or orders in single
options series. A complex order may be received by the Exchange
electronically, and the legs of the complex order may have different
counterparties.

    If a complex order executes against individual legs and at least
one of the legs qualifies as an Obvious or Catastrophic Error under
this Rule 6.25, then the leg(s) that is an Obvious or Catastrophic
Error will be adjusted in accordance with paragraphs (c)(4)(A) or
(d)(3), respectively, regardless of whether one of the parties is a
Customer. However, any Customer order subject to this paragraph (a)
will be nullified if the adjustment would result in an execution
price higher (for buy transactions) or lower (for sell transactions)
than the Customer's limit price on the complex order or individual
leg(s). If any leg of a complex order is nullified, the entire
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transaction is nullified.

    At least one of the legs of the complex order must qualify as an
obvious or catastrophic error under the initial harmonized rule in
order for the complex order to receive obvious or catastrophic error
relief. Thus, when the Exchange is notified (within the timeframes set
forth in paragraph (c)(2) or (d)(2)) of a complex order that is a
possible obvious error or catastrophic error, the Exchange will first
review the individual legs of the complex order to determine if one or
more legs qualify as an obvious or catastrophic error.\8\ If no leg
qualifies as an obvious or catastrophic error, the transaction stands--
no adjustment and no nullification.
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    \8\ Because a complex order can execute against the leg market,
the Exchange may also be notified of a possible obvious or
catastrophic error by a counterparty that received an execution in
an individual options series. If upon review of a potential obvious
error the Exchange determines an individual options series was
executed against the leg of a complex order or stock-option order,
proposed Rule 6.25.07 will govern.
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    Reviewing the legs to determine whether one or more legs qualify as
an obvious or catastrophic error requires the Exchange to follow the
initial harmonized rule. In accordance with paragraphs (c)(1) and
(d)(1) of the initial harmonized rule, the Exchange compares the
execution price of each individual leg to the Theoretical Price \9\ of
each leg (as determined by paragraph (b) of the initial harmonized
rule). Under the proposed rule, if the execution price of an individual
leg is higher or lower than the Theoretical Price for the series by an
amount equal to at least the amount shown in the obvious error table in
paragraph (c)(1) of the initial harmonized rule or the catastrophic
error table in paragraph (d)(1) of the initial harmonized rule, the
individual leg qualifies as an obvious or catastrophic error, and the
Exchange will take steps to adjust or nullify the transaction.\10\
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    \9\ See Rule 6.25(b) (defining the manner in which Theoretical
Price is determined).
    \10\ Only the execution price on the leg (or legs) that
qualifies as an obvious or catastrophic error pursuant to any
portion of proposed Rule 6.25.07 will be adjusted. The execution
price of a leg (or legs) that does not qualify as an obvious or
catastrophic error will not be adjusted.
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    Paragraph (c)(4)(A) of the initial harmonized rule mandates that if
it is determined that an obvious error has occurred, the execution
price of the transaction will be adjusted pursuant to the table set
forth in (c)(4)(A).\11\ Although for simple orders paragraph (c)(4)(A)
is only applicable when no party to the transaction is a Customer,\12\
for the purposes of complex orders, paragraph (a) of proposed
Interpretation and Policy .07 will supersede that limitation;
therefore, if it is determined that a leg (or legs) of a complex order
is an obvious error, the leg (or legs) will be adjusted pursuant to
paragraph (c)(4)(A), regardless of whether a party to the transaction
is a Customer. The Size Adjustment Modifier defined in subparagraph
(a)(4) will similarly apply (regardless of whether a Customer is on the
transaction) by virtue of the application of paragraph (c)(4)(A).\13\
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    \11\ In contrast, paragraph (d)(3) of the initial harmonized
rule mandates that if it is determined that a catastrophic error has
occurred, the execution price of the transaction will be adjusted
pursuant to the table set forth in paragraph (d)(3). However, if a
Customer is a party to the transaction and the adjustment would
result in an execution price higher (for buy transactions) or lower
(for sell transactions) than the Customer's limit price, the
Customer order will be nullified.
    \12\ See Rule 6.25(a)(1) (defining Customer for purposes of Rule
6.25 as not including a broker-dealer, Professional Customer, or
Voluntary Professional Customer).
    \13\ See Rule 6.25(c)(4)(A) (stating that any non-Customer
Obvious Error exceeding 50 contracts will be subject to the Size
Adjustment Modifier defined in sub-paragraph (a)(4)). The Size
Adjustment Modifier may also apply to the option leg of a stock-
option order that is adjusted pursuant to proposed Rule 6.25.07(c).
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    Pursuant to proposed Rule 6.25.07(a), if a complex order executes
against individual legs and at least one of the leg(s) qualifies as an
Obvious Error or a Catastrophic Error, then the leg(s) that is an
Obvious or Catastrophic error will be adjusted in accordance with
paragraphs (c)(4)(A) or (d)(3) of the initial harmonized rule,
respectively, regardless of whether one of the parties is a Customer.
However, because incoming complex orders may execute against resting
simple orders in the leg market and adjusting the execution price of
the leg may violate the limit price of the resting order, proposed Rule
6.25.07(a) also provides protection for Customer orders, stating that
where at least one party to a complex order transaction is a Customer,
the transaction will be nullified if adjustment would result in an
execution price higher (for buy transactions) or lower (for sell
transactions) than the Customer's limit price on the complex order or
individual leg(s). If any leg of a complex order is nullified, the
entire transaction will be nullified.
2. Complex Orders Executed Against Complex Orders
    Proposed Interpretation and Policy .07(b) governs the review of
complex orders that are executed against other complex orders. Proposed
Rule 6.25.07(b) provides:

    If a complex order executes against another complex order and at
least one of the legs qualifies as an Obvious Error under paragraph
(c)(1) or a Catastrophic Error under paragraph (d)(1), then the
leg(s) that is an Obvious or Catastrophic Error will be adjusted or
busted in accordance with paragraph (c)(4) or (d)(3), respectively,
so long as either: (i) The width of the National Spread Market for
the complex order strategy just prior to the erroneous transaction
was equal to or greater than the amount set forth in the wide quote
table of paragraph (b)(3) or (ii) the net execution price of the
complex order is higher (lower) than the offer (bid) of the National
Spread Market for the complex order strategy just prior to the
erroneous transaction by an amount equal to at least the amount
shown in the table in paragraph (c)(1). If any leg of a complex
order is nullified, the entire transaction is nullified. For
purposes of Rule 6.25, the National Spread Market for a complex
order strategy is determined by the National Best Bid/Offer of the
individual legs of the strategy.

As described above in relation to proposed Rule 6.25.07(a), the first
step is for the Exchange to review (upon receipt of a timely
notification in accordance with paragraph (c)(2) or (d)(2) of the
initial harmonized rule) the individual legs to determine whether a leg
or legs qualifies as an obvious or catastrophic error. If no leg
qualifies as an obvious or catastrophic error, the transaction stands--
no adjustment and no nullification.
    Unlike proposed Rule 6.25.07(a), the Exchange also proposes to
compare the

net execution price of the entire complex order package to the National
Spread Market for the complex order strategy.\14\ Complex orders are
exempt from the order protection rules of the options exchanges.\15\
Thus, depending on the manner in which the systems of an options
exchange are calibrated, a complex order can execute without regard to
the prices offered in the complex order books or the leg markets of
other options exchanges. Accordingly, the Exchange proposes to consider
the National Spread Market. Specifically, proposed Rule 6.25.07(b)
provides that if the Exchange determines that a leg or legs does
qualify as an obvious or catastrophic error, the leg or legs will be
adjusted or busted in accordance with paragraph (c)(4) or (d)(3) of the
initial harmonized rule, so long as either: (i) The width of the
National Spread Market for the complex order strategy just prior to the
erroneous transaction was equal to or greater than the amount set forth
in the wide quote table of paragraph (b)(3) of the initial harmonized
rule or (ii) the net execution price of the complex order is higher
(lower) than the offer (bid) of the National Spread Market for the
complex order strategy just prior to the erroneous transaction by an
amount equal to at least the amount shown in the table in paragraph
(c)(1) of the initial harmonized rule.
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    \14\ National Spread Market is the derived net market for a
complex order package. See, e.g., Rule 6.53C.04 (utilizing the term
derived net market in the context of complex order strategies).
    \15\ See Rule 6.81(b)(7). All options exchanges have the same
order protection rule.
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    For purposes of complex orders that meet the requirements of
proposed Rule 6.25.07(b), the Exchange proposes to apply the initial
harmonized rule and adjust or bust obvious errors in accordance with
paragraph (c)(4) (as opposed to applying only paragraph (c)(4)(A) as is
the case under proposed Rule 6.25.07(a)) and catastrophic errors in
accordance with paragraph (d)(3). Therefore, for purposes of complex
orders under proposed Rule 6.25.07(b), if one of the legs is determined
to be an obvious error under paragraph (c)(1), all Customer
transactions will be nullified, unless a Trading Permit Holder
(``TPH'') submits 200 or more Customer transactions for review in
accordance with paragraph (c)(4)(C).\16\ For purposes of complex orders
under proposed Rule 6.25.07(b), if one of the legs is determined to be
a catastrophic error under paragraph (d)(3) and all of the other
requirements of proposed Rule 6.25.07(b) are met, all market
participants will be adjusted in accordance with the table set forth in
paragraph (d)(3). Again, however, pursuant to paragraph (d)(3) where at
least one party to a complex order transaction is a Customer, the
transaction will be nullified if adjustment would result in an
execution price higher (for buy transactions) or lower (for sell
transactions) than the Customer's limit price on the complex order or
individual leg(s). Also, if any leg of a complex order is nullified,
the entire transaction is nullified.
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    \16\ Rule 6.25(c)(4)(C) also requires the orders resulting in
200 or more Customer transactions to have been submitted during the
course of 2 minutes or less.
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3. Stock-Option Orders
    Proposed Interpretation and Policy .07(c) governs stock-option
orders. Proposed Rule 6.25.07(c) provides:

    If the option leg of a stock-option order qualifies as an
Obvious Error under paragraph (c)(1) or a Catastrophic Error under
paragraph (d)(1), then the option leg that is an Obvious or
Catastrophic Error will be adjusted in accordance with paragraph
(c)(4)(A) or (d)(3), respectively, regardless of whether one of the
parties is a Customer. However, the option leg of any Customer order
subject to this paragraph (c) will be nullified if the adjustment
would result in an execution price higher (for buy transactions) or
lower (for sell transactions) than the Customer's limit price on the
stock-option order, and the Exchange will attempt to nullify the
stock leg. Whenever a stock trading venue nullifies the stock leg of
a stock-option order or whenever the stock leg cannot be executed,
the Exchange will nullify the option leg upon request of one of the
parties to the transaction or in accordance with paragraph (c)(3).

    Similar to proposed Interpretation and Policy .07(a), an option leg
(or legs) of a stock-option order must qualify as an obvious or
catastrophic error under the initial harmonized rule in order for the
stock-option order to qualify as an obvious or catastrophic error.
Also, similar to proposed Rule 6.25.07(a), if an option leg (or legs)
does qualify as an obvious or catastrophic error, the option leg (or
legs) will be adjusted in accordance with paragraph (c)(4)(A) or
(d)(3), respectively, regardless of whether one of the parties is a
Customer. Again, as with proposed Rule 6.25.07(a), where at least one
party to a complex order transaction is a Customer, the Exchange will
nullify the option leg and attempt to nullify the stock leg if
adjustment would result in an execution price higher (for buy
transactions) or lower (for sell transactions) than the Customer's
limit price on the complex order or individual leg(s).
    Finally, the Exchange proposes to provide guidance that whenever
the stock trading venue nullifies the stock leg of a stock-option
order, the option will be nullified upon request of one of the parties
to the transaction or by an Official acting on their own motion in
accordance with paragraph (c)(3). The Exchange states that there are
situations in which buyer and seller agree to trade a stock-option
order, but the stock leg cannot be executed. Thus, the Exchange
proposes to provide that whenever the stock portion of a stock-option
order cannot be executed, the Exchange will nullify the option leg upon
request of one of the parties to the transaction or on an Official's
own motion.
    In order to ensure that other options exchanges are able to adopt
rules consistent with this proposal and to coordinate the effectiveness
of such harmonized rules, the Exchange proposes to delay the
effectiveness of this proposal to April 17, 2017.\17\
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    \17\ See Amendment No. 1.
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III. Discussion and Commission Findings

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\18\ In
particular, the Commission finds that the proposed rule change, as
amended, is consistent with the requirements of Section 6(b) of the Act
\19\ and with Section 6(b)(5) of the Act,\20\ which requires, among
other things, that the Exchange's rules be designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest.
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    \18\ In approving this proposed rule change, as amended, the
Commission notes that it has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \19\ 15 U.S.C. 78f(b).
    \20\ 15 U.S.C. 78f(b)(5).
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    The Commission believes that the proposal to amend Rule 6.25 will
help assure greater objectivity, transparency, and clarity with respect
to the adjustment and nullification of erroneous options transactions
and, in particular, those involving complex order or stock-option order
transactions. The Commission notes that the proposal is designed to
achieve more consistent results for participants across U.S. options
exchanges than under the initial harmonized rules, while maintaining a
fair and orderly market, protecting investors, and protecting the
public

interest. In particular, the proposal is designed to increase the
consistency and transparency in the handling of erroneous options
transactions among those options exchanges that allow complex order or
stock-option order transactions.
    In its order approving the initial harmonized rule of BATS
Exchange, Inc., the Commission noted that the options exchanges
intended to work together to further develop additional objectivity
with respect to their processes for the adjustment and nullification of
erroneous options transactions.\21\ The Commission believes that the
proposed rule change to specifically delineate the treatment of
erroneous complex order or stock-option order transactions constitutes
an additional step towards this goal. Based on the foregoing, the
Commission believes that the proposed rule change is consistent with
Section 6(b)(5) of the Act \22\ in that proposed Rule 6.25 will foster
cooperation and coordination with persons engaged in regulating and
facilitating transactions.
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    \21\ See BATS Order, supra note 5, at 16039.
    \22\ 15 U.S.C. 78f(b)(5).
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    The Commission notes that the proposed rule change will become
operative on April 17, 2017. This delayed implementation is to ensure
that other options exchanges that permit transactions in complex orders
or stock-option orders will have sufficient time to put in place
similar rules consistent with this proposed rule change and to
coordinate the date of implementation of such harmonized rules.\23\
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    \23\ See Amendment No. 1.
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IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\24\ that the proposed rule change, as modified by Amendment No. 1
(SR-CBOE-2016-088) be, and hereby is, approved.
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    \24\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\25\
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    \25\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-03295 Filed 2-17-17; 8:45 am]
BILLING CODE 8011-01-P