[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48631-48633]
[FR Doc No: 2018-20903]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2268]

Insanitary Conditions at Compounding Facilities; Revised Draft
Guidance for Industry; Availability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the availability of a revised draft guidance for industry entitled,
``Insanitary Conditions at Compounding Facilities.'' Drug products
compounded under insanitary conditions could become contaminated and
cause serious adverse events, including death, in patients. FDA is
issuing this revised draft guidance to help compounding facilities
identify insanitary conditions so that they can implement appropriate
corrective actions. This revised draft guidance is also intended to
help state regulatory agencies understand some examples of what FDA
considers to be insanitary conditions that could cause a drug to become
contaminated or rendered injurious to health. This guidance revises the
draft guidance entitled ``Insanitary Conditions at Compounding
Facilities'' that was published on August 4, 2016.

DATES: Submit either electronic or written comments on the draft
guidance by November 26, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins works on the final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-2016-D-2268 for ``Insanitary Conditions at Compounding
Facilities.'' 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)).
    Submit written requests for single copies of the revised draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the revised draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-
3110.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Insanitary Conditions at Compounding Facilities.''
Under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 351(a)(2)(A)), a drug is adulterated if it has
been prepared, packed, or held under insanitary conditions whereby it
may have been contaminated with filth or rendered injurious to health.
Drug products compounded under insanitary conditions could become
contaminated and cause serious adverse events, including death, in
patients. Although sections 503A and 503B of the FD&C Act (21 U.S.C.
353a and 353b) provide exemptions for compounded drugs from specified
provisions of the FD&C Act if certain conditions are met, neither
section provides an exemption from section 501(a)(2)(A) of the FD&C
Act. Any drug that is prepared, packed, or held under insanitary
conditions is deemed to be adulterated under the FD&C Act, including
drugs produced by a compounding facility.
    Since a 2012 fungal meningitis outbreak associated with injectable
drug products that a pharmacy compounded and shipped to patients and
health care providers across the country, the Agency has identified
insanitary conditions at many of the compounding facilities that it has
inspected, and numerous compounders have voluntarily recalled drug
products intended to be sterile and temporarily or permanently ceased
sterile operations because of these findings. FDA does not inspect the
vast majority of compounding facilities in the United States because
they generally do not register with FDA unless they are outsourcing
facilities. Therefore, unless FDA receives a complaint, such as a
report of a serious adverse event or visible contamination, the Agency
is often not aware of these facilities, their conditions and practices,
and potential problems with the quality and safety of their drug
products. It is critical that compounding facilities identify and
remediate any insanitary conditions at their facilities before the
conditions result in drug contamination and patient injury.
    In the Federal Register of August 4, 2016 (81 FR 51449), FDA
announced the availability of a draft guidance for industry entitled,
``Insanitary Conditions at Compounding Facilities.'' The draft guidance
provided examples of insanitary conditions that the Agency has observed
at compounding facilities it has inspected and considers to be
insanitary conditions. The draft guidance also described corrective
actions that compounding facilities should take when they identify such
conditions and the regulatory actions FDA may take in response to
identified insanitary conditions. FDA received comments on the draft
guidance including feedback from various stakeholders (e.g.,
physicians, pharmacies), particularly concerning the implications of
the policies described in the draft guidance for physicians who prepare
drugs in their offices. FDA is revising the draft guidance to address
the stakeholders' feedback and to provide further clarification on the
insanitary conditions described in the guidance, as well as the actions
FDA intends to take with respect to insanitary conditions. FDA is
issuing this revised draft guidance to enable the public to further
review and comment before finalization of FDA's policies concerning
insanitary conditions. We

expect that the guidance will help compounding facilities to identify
insanitary conditions so that they can implement appropriate corrective
actions, and will assist states in identifying insanitary conditions
during their inspections of compounding facilities.
    This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent the current thinking of FDA on
``Insanitary Conditions at Compounding Facilities.'' 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.

II. Electronic Access

    Persons with access to the internet may obtain the revised draft
guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20903 Filed 9-25-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 225 (Thursday, November 21, 2019)]
[Proposed Rules]
[Pages 64243-64244]
[FR Doc No: 2019-25166]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2019-0553; FRL-10002-39-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
West Virginia; 2019 Amendments to West Virginia's Ambient Air Quality
Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a state implementation plan (SIP) revision submitted by the
State of West Virginia. This revision updates the effective date of the
national ambient air quality standards (NAAQS) and the associated
monitoring reference and equivalent methods for those NAAQS that West
Virginia incorporates by reference into its state regulations. This
action is being taken under the Clean Air Act (CAA).

DATES: Written comments must be received on or before December 23,
2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2019-0553, at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be confidential business information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Joseph Schulingkamp, Planning &
Implementation Branch (3AD30), Air & Radiation Division, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103. The telephone number is (215) 814-
2021. Mr. Schulingkamp can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On May 6, 2019, the West Virginia Department
of Environmental Protection (WVDEP) submitted a formal revision to its
SIP pertaining to amendments of Legislative Rule, 45CSR8--Ambient Air
Quality Standards. The SIP submittal updates the version of the federal
NAAQS and the associated monitoring reference and equivalent methods
for those NAAQS that West Virginia incorporates by reference into West
Virginia's legislative rules.

I. Summary of SIP Revision

    WVDEP has historically chosen to incorporate by reference the
federal NAAQS, found at 40 CFR part 50, and the associated federal
ambient air monitoring reference methods and equivalent methods for
these NAAQS found at 40 CFR part 53. When incorporating by reference
these federal regulations, WVDEP has specified that it is incorporating
by reference these regulations as they existed on a certain date. The
incorporation by reference of the NAAQS that is currently SIP-approved
by EPA incorporates by reference 40 CFR parts 50 and 53 as they existed
on June 1, 2017. This SIP revision updates the State's incorporation by
reference of the primary and secondary NAAQS and the ambient air
monitoring reference and equivalent methods, found in 40 CFR parts 50
and 53, respectively. Since the last West Virginia incorporation by
reference of June 1, 2017, EPA reviewed the primary standards for
oxides of nitrogen (NOX), as required by CAA section 109(d),
and retained the current 1-hour and annual nitrogen dioxide
(NO2) standards without revision. See 83 FR 17226. EPA has
not made any changes to the ambient air monitoring reference methods or
any ambient air monitoring equivalent methods since the last effective
date of the West Virginia rule.
    The amendments to the legislative rule include the following
changes: To section 45-8-1 (General), the filing, effective, and
incorporation by reference dates are changed to reflect the update of
the legislative rule, subsection 1.5 was renumbered to subsection 1.6,
and a new subsection 1.5 (Sunset Provision) was added; to section 45-8-
3 (Adoption of Standards), the dates of the primary and secondary NAAQS
and the ambient air monitoring reference and equivalent methods that
are to be incorporated by reference are changed. The filing and
effective dates of the legislative rule were updated to April 24, 2019
and June 1, 2019 respectively. The date of the federal rules in 40 CFR
parts 50 and 53 that are being incorporated by reference into 45-8-3
are changed from June 1, 2017 to June 1, 2018.

II. Proposed Action

    EPA is proposing to approve the West Virginia SIP revision updating
the date of incorporation by reference, which was submitted on May 6,
2019. EPA is soliciting public comments on the update to West
Virginia's incorporation by reference. Please note that EPA is not
seeking public comment on the level of the NAAQS being incorporated by
reference into the West Virginia regulations. An opportunity for public
comment on the level of each individual NAAQS was given when EPA
proposed each such NAAQS. Relevant comments will be considered before
taking final action.

III. Incorporation by Reference

    In this document, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference 45CSR8, as effective on June 1, 2019. EPA has made, and will
continue to make, these materials generally available through https://www.regulations.gov and at the EPA Region III Office (please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting

Federal requirements and does not impose additional requirements beyond
those imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Public Law 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule, revising the incorporation by
reference date of 45CSR8, does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Lead, Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

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

    Dated: October 28, 2019.
Cosmo Servidio,
Regional Administrator, Region III.
[FR Doc. 2019-25166 Filed 11-20-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Rules and Regulations]
[Pages 52177-52180]
[FR Doc No: 2014-20241]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0617; Directorate Identifier 2014-CE-019-AD;
Amendment 39-17962; AD 2014-17-09
RIN 2120-AA64

Airworthiness Directives; Various de Havilland Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Harry E. Williams de Havilland Model DH 82A airplanes, all Cliff
Robertson de Havilland Model DH 82A airplanes, and all de Havilland
Model DH 83 airplanes. This AD requires inspecting the aircraft
maintenance records and/or the installed lateral fuselage tie rods and

attaching nuts to determine the origin of manufacture. This AD also
requires immediately replacing lateral fuselage tie rods and attaching
nuts produced by a specific manufacturer. This AD was prompted by
reports of structural failure of the attachment of the wing to the
fuselage that resulted from failed lateral fuselage tie rods. We are
issuing this AD to correct the unsafe condition on these products.

DATES: This AD is effective September 18, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September
18, 2014.
    We must receive comments on this AD by October 20, 2014.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, for de Havilland DH
82A airplanes, contact de Havilland Support Ltd., Building 213, Duxford
Airfield, Cambridge, United Kingdom CB22 4QR, telephone: +44 (0) 1223
830090; fax: +44 (0) 1223 83008; email<EMAIL_ADDRESS>Internet:
http://www.dhsupport.com/moth.php.
    For service information identified in this AD, for de Havilland DH
83, contact Air Stratus Ltd., Oaksey Park Airfield, Oaksey, Malmesbury,
Wiltshite, United Kingdom SN 16 9SD, telephone: +44 (0) 1666 575111; no
known Internet address.
    You may view this referenced service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64016. For
information on the availability of this material at the FAA, call (816)
329-4148.

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-2014-
0617; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (phone:
800-647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: For airplanes covered under Type
Certificate Data Sheet (TCDS) A5PC (Model de Havilland DH 82A airplanes
built in Australia): Andrew McAnaul, Aerospace Engineer, FAA, Fort
Worth Airplane Certification Office, ASW-150 (c/o San Antonio MIDO),
10100 Reunion Place, Suite 650, San Antonio, Texas 78216; phone: (210)
308-3365; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    For airplanes covered under TCDS A8EU (Model de Havilland DH 82A
airplanes built in the United Kingdom): Fred Guerin, Aerospace
Engineer, FAA, Los Angeles Aircraft Certification Office, 3960
Paramount Blvd., Suite 100, Lakewood, California 90712; phone (562)
627-5232; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    For airplanes covered under TCDS 2-439 (Model de Havilland DH 83
airplanes built in the United Kingdom): Karl Schletzbaum, Aerospace
Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas
City, Missouri 64106; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We received a report from the Australia Transportation Safety Board
(ASTB) of accident investigation results on a de Havilland Model DH 82A
airplane, which had a wing failure in flight. Investigation revealed
that both of the accident airplane's fuselage lateral tie rods, which
join the lower wings to the fuselage, were found fractured in three of
the four threaded sections near the join with the left wing. The failed
lateral fuselage tie rods, part number JRA-776-1, were under an
Australian parts manufacturing approval (PMA) and were found to have
different characteristics than the OEM parts.
    Although the defective PMA parts were manufactured in Australia,
some airplanes of U.S. registry may have the PMA parts installed.
    De Havilland Model DH 82A airplanes (commonly referred to as Tiger
Moths) are type certificated under two type certificates. TCDS A5PC,
currently held by Harry E. Williams, is for airplanes built in
Australia, and TCDS A8EU, currently held by Cliff Robertson, c/o
Gadbois Business Management, is for airplanes built in the United
Kingdom. This type certification approval was not by validation, but by
an acceptance process; as such, the U.S. type certificate holders are
not the manufacturers of the airplanes and the original manufacturers
(de Havilland and its licensees) are not type certificate holders.
    De Havilland Support Ltd (DHSL) holds the type certificate
responsibility for de Havilland Model DH 82A airplanes (the type design
for TCDS A8EU) in the United Kingdom.
    DHSL is custodian of the airframe design data, manufacturing
drawings, and repair schemes still in existence for de Havilland Model
DH 82A Tiger Moth series airplanes only. In 2012, DHSL entered into a
CAA Type Responsibility Agreement (TRA) so that the airplane remains
eligible, if required, for an ICAO-compliant Certificate of
Airworthiness to facilitate training and pleasure flying.
    Similarly, Air Stratus Ltd holds the type certificate
responsibility for de Havilland Model DH 83 airplanes (the type design
for TCDS 2-439) in the United Kingdom.
    The process for making mandatory continuing airworthiness
information (MCAI) issued by an aviation authority of another country
mandatory for airplanes of U.S. registry is through rulemaking.
    This condition, if not corrected, could result in structural
failure of the attachment of the wing to the fuselage. We are issuing
this AD to correct the unsafe condition on these products.

Relevant Service Information

    We reviewed British Aerospace Military Aircraft and Aerostructures
BAe Aircraft Bulletin for de Havilland Moth Aircraft, Document Type and
Ref No Technical News Sheet CT (Moth) No 29, Issue 3, dated March 1,
1999, which was approved by the Civil Aviation Authority (CAA) for the
United Kingdom to ensure the continued airworthiness of these airplanes
in the United Kingdom. The service information describes procedures for
replacing the lateral tie rods and attaching nuts.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

AD Requirements

    This AD requires inspecting the aircraft maintenance records and/or
the installed lateral fuselage tie rods and attaching nuts to determine
if they were produced by J & R Aerospace Pty Ltd. This AD also requires
replacing all lateral fuselage tie rods and attaching nuts produced by
J & R Aerospace Pty Ltd with airworthy parts.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because
structural failure of the attachment of the wing to the fuselage could
result in loss of control. Therefore, we find that notice and
opportunity for prior public comment are impracticable and that good
cause exists for making this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, we invite you to send any written data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include the docket number FAA-2014-0617 and
Directorate Identifier 2014-CE-019-AD at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this AD. We will
consider all comments received by the closing date and may amend this
AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD affects 69 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
              Action                     Labor cost            Parts cost           product         operators
----------------------------------------------------------------------------------------------------------------
Inspect the aircraft maintenance    1 work-hour x $85     Not applicable......             $85           $5,865
 records and/or the lateral          per hour = $85.
 fuselage tie rod s and attaching
 nuts to determine the lateral
 fuselage tie rods and attaching
 nuts origin of manufacture.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the inspection. We have
no way of determining the number of airplanes that might need this
replacement:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replace lateral fuselage tie rods and          30 work-hours x $85 per hour =             $825           $3,375
 attaching nuts.                                $2,550.
----------------------------------------------------------------------------------------------------------------

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) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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):

2014-17-09 Harry E. Williams, Cliff Robertson, and de Havilland
Airplanes: Amendment 39-17962; Docket No.

FAA-2014-0617; Directorate Identifier 2019-CE-019-AD.

(a) Effective Date

    This AD is effective September 18, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Harry E. Williams and Cliff Robertson Model
de Havilland DH 82A airplanes, all serial numbers, and de Havilland
Model DH 83 airplanes, all serial numbers, certificated in any
category.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 5341, Fuselage, Wing Attach Fittings.

(e) Unsafe Condition

    This AD was prompted by reports of structural failure of the
attachment of the wing to the fuselage that resulted from failed
lateral fuselage tie rods. We are issuing this AD to correct the
unsafe condition on these products.

(f) Compliance

    Comply with this AD within the compliance times specified in
paragraphs (g) through (j) of this AD, unless already done.

(g) Restrict Airplane Operation

    (1) As of September 18, 2014 (the effective date of this AD),
the airplane is restricted to non-aerobatic flight until the actions
required in paragraphs (h)(1) through (i)(1) of this AD are done.
    (2) As of September 18, 2014 (the effective date of this AD),
before further flight, place a copy of this AD into the Limitations
section of the airplane flight manual (AFM).

(h) Determine Manufacture of Installed Lateral Fuselage Tie Rods and
Attaching Nuts

    Within the next 10 hours time-in-service (TIS) after September
18, 2014 (the effective date of this AD), review the aircraft
maintenance records and/or inspect the installed lateral fuselage
tie rods and attaching nuts to determine if the lateral fuselage tie
rods and attaching nuts were produced by J & R Aerospace Pty Ltd.,
P/N JRA-776-1 (for de Havilland Model DH 82A airplanes), and P/N
JRA-776-3 (for de Havilland Model DH 83 airplanes).
    (1) If you are able to positively determine that the installed
lateral fuselage tie rods and attaching nuts are not produced by J &
R Aerospace Pty Ltd, remove the flight restriction required in
paragraph (g) of this AD, and no further action is required by this
AD.
    (2) If you are not able to positively determine that the
installed lateral fuselage tie rods and attaching nuts are not
produced by J & R Aerospace Pty Ltd or if you determine that the
installed lateral fuselage tie rods and attaching nuts are produced
by J & R Aerospace, before further flight, remove and replace the
lateral fuselage tie rods and attaching nuts as specified in
paragraph (i) of this AD.

(i) Remove and Replace Lateral Fuselage Tie Rods and Attaching Nuts
Produced by J & R Aerospace Pty Ltd

    (1) Before further flight after making the determination
required in paragraph (h)(2) of this AD, remove and destroy the
installed lateral fuselage tie rods and attaching nuts and replace
the lateral fuselage tie rods and attaching nuts. Replace the
lateral tie rods and attaching nuts following the procedures in
paragraph 2.C. of the Accomplishment Instructions and using the
table on Figure 1 in British Aerospace Military Aircraft and
Aerostructures BAe Aircraft Bulletin for De Havilland Moth Aircraft,
Document Type and Ref No Technical News Sheet CT (Moth) No 29, Issue
3, dated March 1, 1999.
    (2) Before further flight after doing the replacement required
in paragraph (i)(1) of this AD, remove the flight restriction
required in paragraph (g) of this AD.

(j) Prohibited Installation

    As of September 18, 2014 (the effective date of this AD), do not
install P/N JRA-776-1 or JRA-776-3 lateral fuselage tie rods
manufactured under Australian part manufacture approval (PMA)
manufacturer J & R Aerospace Pty Ltd.

(k) Special Flight Permit

    Special flight permits are permitted with the following
limitations:
    (1) No passengers,
    (2) Day VRF only,
    (3) Straight and level flight, and
    (4) Avoid areas of known turbulence.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager of the Fort Worth Airplane Certification Office
(ACO), the Manager of the Los Angeles Aircraft Certification Office
(ACO), and the Manager of the Standards Office, FAA, have the
authority to approve AMOCs for their respective products covered by
this AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the manager of the applicable FAA
office, send it to the attention of the person identified in
paragraph (n).
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(m) Related Information

    (1) For more information about this AD for airplanes covered
under TCDS A5PC (Model de Havilland DH 82A airplanes built in
Australia), contact Andrew McAnaul, Aerospace Engineer, FAA, Fort
Worth ACO, ASW-150 (c/o San Antonio MIDO), 10100 Reunion Place,
Suite 650, San Antonio, Texas 78216; phone:<PHONE_NUMBER>; fax:
(210) 308-3370; email<EMAIL_ADDRESS>    (2) For more information about this AD for airplanes covered
under TCDS A8EU (Model de Havilland DH 82A airplanes built in the
United Kingdom), contact Fred Guerin, Aerospace Engineer, FAA, Los
Angeles ACO, 3960 Paramount Blvd., Suite 100, Lakewood, California
90712; phone<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (3) For more information about this AD for airplanes covered
under TCDS 2-439 (Model de Havilland DH 83 airplanes built in the
United Kingdom), contact Karl Schletzbaum, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
(n) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) British Aerospace Military Aircraft and Aerostructures BAe
Aircraft Bulletin for De Havilland Moth Aircraft, Document Type and
Ref No Technical News Sheet CT (Moth) No 29, Issue 3, dated March 1,
1999.
    (ii) Reserved.
    (3) For British Aerospace Military Aircraft and Aerostructures
BAe Aircraft Bulletin for De Havilland Moth Aircraft, Technical New
Sheet CT (Moth) No 29, Issue 3, dated March 1, 1999, service
information identified in this AD, contact:
    (i) For de Havilland DH 82A airplanes: de Havilland Support Ltd,
Building 213, Duxford Airfield, Cambridge, United Kingdom CB22 4QR,
telephone: +44 (0) 1223 830090; fax: +44 (0) 1223 83008; email:
<EMAIL_ADDRESS>Internet: http://www.dhsupport.com/moth.php.
    (ii) For de Havilland DH 83 airplanes: Air Stratus Ltd., Oaksey
Park Airfield, Oaksey, Malmesbury, Wiltshite, United Kingdom SN 16
9SD, telephone: +44 (0) 1666 575111; no known Internet address.
    (4) You may view this service information at FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64016. For
information on the availability of this material at the FAA, call
(816) 329-4148.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on August 19, 2014.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2014-20241 Filed 9-2-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 129 (Friday, July 5, 2019)]
[Notices]
[Pages 32245-32246]
[FR Doc No: 2019-14276]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86246; File No. SR-NASDAQ-2019-017]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Order
Granting Approval of a Proposed Rule Change To Adopt Additional
Requirements for Listings in Connection With an Offering Under
Regulation A of the Securities Act

June 28, 2019.

I. Introduction

    On April 5, 2019, The Nasdaq Stock Market LLC (``Nasdaq'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Exchange Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to adopt a new initial listing
requirement for any company applying to list on the Exchange in
connection with an offering under Regulation A \3\ of the Securities
Act of 1933 (``Securities Act'').\4\ The proposed rule change was
published for comment in the Federal Register on April 24, 2019.\5\ The
Commission received one comment in support of the proposed rule
change.\6\ On June 7, 2019, pursuant to Section 19(b)(2) of the Act,\7\
the Commission designated a longer period within which to approve the
proposed rule change, disapprove the proposed rule change, or institute
proceedings to determine whether to approve or disapprove the proposed
rule change.\8\ This order approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 230.251-230.263.
    \4\ 15 U.S.C. 77a et seq.
    \5\ See Securities Exchange Act Release No. 85687 (April 18,
2019), 84 FR 17224 (April 24, 2019) (``Notice'').
    \6\ See Letter from Jeffrey P. Mahoney, General Counsel, Council
of Institutional Investors, dated May 2, 2019 (``CII Letter''),
available at https://www.sec.gov/comments/sr-nasdaq-2019-017/srnasdaq2019017-5441017-184816.pdf.
    \7\ 15 U.S.C. 78s(b)(2).
    \8\ See Securities Exchange Act Release No. 86067 (June 7,
2019), 84 FR 27672 (June 13, 2019). The Commission designated July
23, 2019, as the date by which the Commission shall approve the
proposed rule change, disapprove the proposed rule change, or
institute proceedings to determine whether to approve or disapprove
the proposed rule change.
---------------------------------------------------------------------------

II. Description and Summary of Comment

    The Exchange proposed to adopt a new initial listing requirement
for companies listing on the Exchange in connection with an offering
under Regulation A of the Securities Act.\9\ Specifically, the Exchange
proposed to require any company listing on the Exchange in connection
with an offering under Regulation A \10\ to have a minimum operating
history of two years at the time of approval of its initial listing
application.\11\
---------------------------------------------------------------------------

    \9\ The Exchange stated that its staff has also adopted
heightened review procedures for companies applying to list on the
Exchange in connection with an offering under Regulation A. See
Notice, supra note 5, at 17225.
    \10\ Regulation A of the Securities Act was amended in 2015 to
implement provisions of the Jumpstart Our Business Startups Act.
Among other things, such amendments provide for an exemption from
registration under the Securities Act for securities offerings of up
to $50 million in a 12-month period. See Securities Exchange Act
Release No. 74578 (March 25, 2015), 80 FR 21805 (April 20, 2015)
(Amendments for Small and Additional Issues Exemptions Under the
Securities Act (Regulation A); Final Rule) (``Regulation A Adopting
Release'').
    \11\ See proposed Rule 5210(j).
---------------------------------------------------------------------------

    The Exchange stated in its proposal that it has observed problems
with certain companies listing on the Exchange in connection with an
offering under Regulation A.\12\ Nasdaq also noted, among other things,
that Regulation A offering statements have lighter disclosure
requirements as compared to a traditional initial public offering on
Form S-1.\13\
---------------------------------------------------------------------------

    \12\ See Notice, supra note 5, at 17225 (citing to Securities
and Exchange Commission vs. Longfin Corp., Case No. 18-cv-2977 (DLC)
(S.D.N.Y., filed April 4, 2018), available at https://www.sec.gov/litigation/complaints/2018/comp-pr2018-61.pdf).
    \13\ See id.
---------------------------------------------------------------------------

    The Exchange stated that it believes that the proposed new minimum
two-year operating history requirement will help assure that a company
listing in connection with an offering under Regulation A has a more
established business plan and a history of operations upon which
investors can rely, has been able to fund the initial phase of its
operations, and will be more likely to be ready for the rigors of being
a public company, including satisfying the Commission's and Exchange's
reporting and corporate governance requirements. The Exchange stated
these are important benefits given the lighter disclosure requirements
associated with Regulation A offerings.\14\
---------------------------------------------------------------------------

    \14\ See id.
---------------------------------------------------------------------------

    Nasdaq proposed that this proposed rule change be effective 30 days
after approval by the Commission, and stated that such 30-day delay
would allow companies that have substantially completed the Nasdaq
review process, or are near completion of their offering, a short
opportunity to complete that offering and list before the new rules
become effective.\15\
---------------------------------------------------------------------------

    \15\ See id.
---------------------------------------------------------------------------

    The Commission received one comment letter in support of the Nasdaq
proposal.\16\ The commenter noted that companies relying on Regulation
A are subject to less burdensome accounting and disclosure standards
than companies conducting a traditional initial public offering on Form
S-1.\17\ The commenter agreed with Nasdaq that its proposal will ``. .
. help assure that [listed] companies have more established business
plans and a history of operations upon which investors can rely'' and
that such more seasoned companies are more likely to be ready for the
rigors of being a public company.\18\
---------------------------------------------------------------------------

    \16\ See CII Letter, supra note 6.
    \17\ See id. at 2.
    \18\ See id. at 3. The commenter also raised additional issues
that were beyond the scope of the Commission's review of this rule
proposal.?>[FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/
DATE][NOTICES][NOTICE][PREAMB][AGENCY]*[/AGENCY][SUBJECT]*[/SUBJECT]
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III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Exchange Act and the
rules and regulations thereunder applicable to a national securities
exchange.\19\ In particular, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Exchange Act,\20\
which requires, among other things, that the rules of a national
securities exchange be designed to prevent fraudulent and manipulative
acts and practices, to promote just and equitable principles of trade,
and, in general, to protect investors and the public interest; and are
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78f(b). In approving this proposed rule change,
the Commission has considered the proposed rule change's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \20\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The development and enforcement of meaningful listing standards for
an exchange is of critical importance to financial markets and the
investing public. Among other things, listing standards provide the
means for an exchange to screen issuers that seek to become listed, and
to provide listed status only to those that are bona fide companies
with sufficient public float, investor base, and trading interest
likely to generate depth and liquidity sufficient to promote fair and
orderly markets. Meaningful listing standards also are important given
investor expectations regarding the nature of securities that have
achieved an

exchange listing, and the role of an exchange in overseeing its market
and assuring compliance with its listing standards.\21\
---------------------------------------------------------------------------

    \21\ See, e.g., Securities Exchange Act Release Nos. 65708
(November 8, 2011), 76 FR 70799 (November 15, 2011) (SR-Nasdaq-2011-
073) (order approving a proposal to adopt additional listing
requirements for companies applying to list after consummation of a
``reverse merger'' with a shell company), and 57785 (May 6, 2008),
73 FR 27597 (May 13, 2008) (SR-NYSE-2008-17) (order approving a
proposal to adopt new initial and continued listing standards to
list securities of special purpose acquisition companies).
---------------------------------------------------------------------------

    The Commission believes the proposed two-year minimum operating
history requirement for companies that seek to list on the Exchange in
connection with an offering under Regulation A of the Securities Act is
reasonably designed to address the Exchange's concerns regarding
maturity and preparedness for listing of these types of issuers.
Regulation A allows companies to raise money from the public in
securities offerings of up to $50 million with the filing of Form 1-A
but with somewhat more limited disclosure requirements than what is
required in a registration statement on Form S-1 for an initial public
offering.\22\ For example, Form 1-A requires less disclosure about the
compensation of officers and directors and less detailed management
discussion and analysis of the issuer's liquidity and capital resources
and results of operations.\23\ The Commission further notes that
Regulation A issuers tend to be smaller companies in earlier stages of
development.\24\ As a general matter, early-stage ventures may be
relying on the development of a new business, product, or service that
may or may not find a market, unlike a mature business that is more
likely to have a track record of revenue or income.
---------------------------------------------------------------------------

    \22\ See Regulation A Adopting Release, supra note 10.
    \23\ See id. at 21889. The Commission notes that a company that
conducts an offering under Regulation A at the same time as listing
can include balance sheets for its last two fiscal years, with no
interim financial statements, whereas a company that conducts an
initial public offering on Form S-1 at the time of listing would be
required to have interim financial statements dated no later than
134 days prior to effectiveness of the Form S-1 and at the time of
listing See Notice, supra note 5, at 17225.
    \24\ See Securities Exchange Act Release No. 86129 (June 18,
2019), 84 FR 30460, 30492-93 (June 26, 2019) (File No. S7-08-19)
(Concept Release on Harmonization of Securities Offering
Exemptions).
---------------------------------------------------------------------------

    The Commission believes, based on the factors discussed above, that
the proposed operating history requirement may help to ensure that a
company listing in connection with a Regulation A offering is more
seasoned, and thus more likely to be ready for the rigors of being a
public, exchange-listed and traded, company, and that therefore the
requirement would be consistent with the investor protection provisions
of Section 6(b)(5) of the Exchange Act. The Commission notes that, as
Nasdaq stated in its proposal, the additional two-year operating
history requirement can help to assure that a company listing in
connection with a Regulation A offering will be more likely to have a
developed business plan upon which investors can rely, was able to
successfully fund its initial phase of operations, and may be more
likely to be better prepared to satisfy public company requirements,
including reporting and corporate governance requirements.
    While capital formation and access to markets is very important,
the Commission notes that the additional listing requirement applies to
a small subset of companies applying to list in connection with a
Regulation A offering and that the Exchange has identified a reasonable
requirement that it believes will help it to ensure the suitability of
such companies for an Exchange listing, consistent with the
requirements of Section 6(b)(5) of the Exchange Act. Finally, the
Commission would expect Nasdaq to review its experience with the new
initial listing standard for Regulation A listed companies and consider
whether the adoption of the new rule has addressed the concerns
identified by Nasdaq and propose any appropriate changes, if necessary,
to its listing standards.
    For the reasons discussed above, the Commission believes that
Nasdaq's proposal will further the purposes of Section 6(b)(5) of the
Exchange Act by, among other things, protecting investors and the
public interest, and preventing fraudulent and manipulative acts and
practices, as well as promoting fair and orderly markets under the
Exchange Act.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Exchange Act,\25\ that the proposed rule change (SR-NASDAQ-2019-017)
be, and it hereby is, approved.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\26\
---------------------------------------------------------------------------

    \26\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-14276 Filed 7-3-19; 8:45 am]
BILLING CODE 8011-01-P?>


[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Notices]
[Pages 38750-38752]
[FR Doc No: 2018-16823]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83762; File No. SR-OCC-2017-810]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing of Partial Amendments No. 1, 2, and 3 to Advance
Notice Concerning Updates to and Formalization of OCC's Recovery and
Orderly Wind-Down Plan

August 1, 2018.

I. Introduction

    Pursuant to Section 806(e)(1) of Title VIII of the Dodd-Frank Wall
Street Reform and Consumer Protection Act, entitled Payment, Clearing,
and Settlement Supervision Act of 2010 (``Clearing Supervision Act'')
\1\ and Rule 19b-4(n)(1)(i) \2\ under the Securities Exchange Act of
1934 (``Act''),\3\ The Options Clearing Corporation (``OCC'') filed
with the Securities and Exchange Commission (``Commission'') an advance
notice pursuant to which OCC would formalize and update its Recovery
and Orderly Wind-Down Plan (``RWD Plan'' or ``Plan''), consistent with
the applicable requirement in Rule 17Ad-22(e)(3)(ii) \4\ (``Advance
Notice''). The Advance Notice was published for public comment in the
Federal Register on January 23, 2018.\5\ On January 23, 2018, the
Commission requested OCC provide it with additional information
regarding the Advance Notice.\6\ OCC responded to this request for
information, and the information was received on July 13, 2018.\7\ On
July 11 and 12, 2018, OCC filed Partial Amendment No. 1 and Partial
Amendment No. 2 to the Initial Filing. On July 12, 2018, OCC also filed
a partial amendment (``Partial Amendment No. 3'') to the Initial
Filing. This Partial Amendment No. 3 is intended to supersede and
replace Amendments No. 1 and 2 in their entirety.\8\ Therefore, the
Initial Filing together with Partial Amendment No. 3 reflects the
changes being proposed.
---------------------------------------------------------------------------

    \1\ 12 U.S.C. 5465(e)(1).
    \2\ 17 CFR 240.19b-4(n)(1)(i).
    \3\ 15 U.S.C. 78a et seq.
    \4\ 17 CFR 240.17Ad-22(e)(3)(ii).
    \5\ See Securities Exchange Act Release No. 82514 (January 17,
2018), 83 FR 3224 (January 23, 2018) (SR-OCC-2017-810) (hereinafter
referred to as the ``Initial Filing''). Initial Filing, 83 FR 3224.
    \6\ See Memorandum from Office of Clearance and Settlement,
Division of Trading and Markets, dated January 23, 2018, available
at https://www.sec.gov/comments/sr-occ-2017-810/occ2017810-2948228-161854.pdf.
    \7\ See Memorandum from Office of Clearance and Settlement,
Division of Trading and Markets, dated July 17, 2018, available at
https://www.sec.gov/comments/sr-occ-2017-810/occ2017810-4062513-169149.pdf.
    \8\ This Partial Amendment No. 3 is substantially the same as
Partial Amendments No. 1 and 2 but would correct certain technical
errors in the previous amendments (e.g., update a cross-reference to
OCC filing SR-OCC-2017-809, as now amended by Amendment No. 2, and
correct a pagination error in Exhibits 4 and 5). Substantive changes
to the Initial Filing, as reflected in Partial Amendment No. 3, are
described in Item II below.
---------------------------------------------------------------------------

    The Advance Notice, as amended by Partial Amendment No. 3 is
described in Item II below, which Item has been prepared by OCC. The
Commission is publishing this notice to solicit comments on the Advance
Notice, as amended by Partial Amendments No. 1, 2 and 3, from
interested persons.

II. Clearing Agency's Statement of the Terms of Substance of Partial
Amendment No. 3 to the Advance Notice

    This Partial Amendment No. 3 would make the following three
amendments to the Initial Filing: (1) Removal of sections of the RWD
Plan concerning OCC's proposed authority to require cash settlement of
certain physically delivered options and single stock futures; (2)
updating the list of OCC's Critical Support Functions; \9\ and (3)
making three changes to Chapter 5 of the RWD Plan in order to conform
to a change contemporaneously proposed in Amendment No. 2 to OCC
advance notice filing SR-OCC-2017-809 concerning enhanced and new tools
for recovery scenarios.\10\
---------------------------------------------------------------------------

    \9\ The amendment to the list of Critical Support Functions
would be made to the confidential and redacted portions of the RWD
Plan.
    \10\ See Amendment No. 2 to SR-OCC-2017-809. The three
amendments to Chapter 5 also would be made to the confidential and
redacted portions of the RWD Plan.
---------------------------------------------------------------------------

    With regard to the removal of sections of the RWD Plan concerning
OCC's proposed authority to require cash settlement of certain
physically delivered options and single stock futures, OCC proposes to
amend the following text on pages 16-17 and 55 of the Initial Filing
(new text is underlined and proposed deletions are marked in
strikethrough text).

[GRAPHIC] [TIFF OMITTED] TN07AU18.002

    OCC also proposes to amend the following text on pages 22-23 and
61-62 of the Initial Filing (including associated footnotes).
[GRAPHIC] [TIFF OMITTED] TN07AU18.003

    OCC plans to resubmit the proposed cash settlement tool previously
filed in SR-OCC-2017-018 and SR-OCC-2017-807 on a separate timeline
from the rest of its enhanced and new tools for recovery scenarios and
would submit a

subsequent filing to the Commission to amend the RWD Plan at that time.
    In addition, OCC proposes to make the following amendments on pages
32 and 71 of the Initial Filing.
[GRAPHIC] [TIFF OMITTED] TN07AU18.024

    With regard to updating the list of OCC's Critical Support
Functions, the amendment would revise OCC's RWD Plan to consistently
identify one of OCC's internal functions as a Critical Support
Function.
    Finally, OCC proposes to make two changes to Chapter 5 of the RWD
Plan, which would align an exhibit, a related list and a related
paragraph with the certain changes OCC is contemporaneously proposing
in Amendment No. 2 to OCC advance notice filing SR-OCC-2017-809
concerning enhanced and new tools for recovery scenarios.\11\
Specifically, OCC would change the aforementioned exhibit, list and
paragraph in Chapter 5 to recognize that while OCC does not intend, in
the first instance for its tear-up process to serve as a means of loss
allocation, circumstances may arise such that, despite best efforts,
OCC has inadequate remaining financial resources to extinguish torn-up
positions at their assigned Tear-Up Price without forcing a reduction
in the amount of unpaid value of such positions (e.g., despite best
efforts, market movements not accounted for by monitoring, additional
Clearing Member defaults occur immediately preceding a tear-up). In
such circumstances, despite best efforts, OCC would use its partial
tear-up process as a means of loss allocation.
---------------------------------------------------------------------------

    \11\ See Amendment No. 2 to SR-OCC-2017-809.
---------------------------------------------------------------------------

    OCC has included an updated Exhibit 5 containing its RWD Plan as
well as an Exhibit 4 showing the changes proposed in this Partial
Amendment No. 3 to the proposed rule text in the Initial Filing, with
the proposed changes in the Initial Filing marked in underlined and
strikethrough text. Exhibits 4 and 5 have been redacted and filed
separately with the Commission and confidential treatment for Exhibits
4 and 5 is requested pursuant to 17 CFR 240.24b-2.
    The Partial Amendments No. 1, 2 and 3 would not change the purpose
of or basis for the proposed changes. All other representations in the
Initial Filing remain as stated therein and no other changes are being
made.

III. Date of Effectiveness of the Advance Notice and Timing for
Commission Action

    The proposed change may be implemented if the Commission does not
object to the proposed change within 60 days of the later of (i) the
date the proposed change was filed with the Commission or (ii) the date
any additional information requested by the Commission is received. OCC
shall not implement the proposed change if the Commission has any
objection to the proposed change.
    The Commission may extend the period for review by an additional 60
days if the proposed change raises novel or complex issues, subject to
the Commission providing the clearing agency with prompt written notice
of the extension. A proposed change may be implemented in less than 60
days from the date the advance notice is filed, or the date further
information requested by the Commission is received, if the Commission
notifies the clearing agency in writing that it does not object to the
proposed change and authorizes the clearing agency to implement the
proposed change on an earlier date, subject to any conditions imposed
by the Commission.
    OCC shall post notice on its website of proposed changes that are
implemented. The proposal shall not take effect until all regulatory
actions required with respect to the proposal are completed.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commissions internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]ec.gov. Please include
File Number SR-OCC-2017-810 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-OCC-2017-810. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the advance notice that are filed with the
Commission, and all written communications relating to the advance
notice between the Commission and any person, other than those that may
be withheld from the public in accordance with the provisions of 5
U.S.C. 552, will be available for website viewing and printing in the
Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of OCC and on OCC's website at
http://www.theocc.com/about/publications/bylaws.jsp.

    All comments received will be posted without change. Persons
submitting comments are cautioned that we do not redact or edit
personal or identifying information from comment submissions. You
should submit only information that you wish to make available
publicly.
    All submissions should refer to File Number SR-OCC-2017-810 and
should be submitted on or before August 22, 2018.

    By the Commission.
Brent J. Fields,
Secretary.
[FR Doc. 2018-16823 Filed 8-6-18; 8:45 am]
BILLING CODE 8011-01-P


 [Federal Register Volume 82, Number 159 (Friday, August 18, 2017)] [Notices] [Pages 39419-39420] [FR Doc No: 2017-17460]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 2771-014, 2766-012, 2768-012]

Notice of Application Accepted for Filing, Soliciting Comments,

Motions To Intervene, and Protests: City of Holyoke Gas & Electric

Department

    Take notice that the following hydroelectric application has been

filed with the Commission and is available for public inspection:

    a. Type of Applications: License surrender.

    b. Project Nos.: 2771-014, 2766-012, 2768-012.

    c. Date Filed: July 21, 2017.

    d. Licensee: City of Holyoke Gas & Electric Department.

    e. Name of Projects: Nonotuck Mill Project No. 2771, Albion Mill (D

Wheel), Project No. 2766, and Albion Mill (A Wheel) Project No. 2768.

    f. Location: Holyoke Canal, Hampden County, Massachusetts.

    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.

    h. Applicant Contact: Mr. Paul Ducheney, City of Holyoke Gas &

Electric Department, 99 Suffolk St., Holyoke, MA 01040,<PHONE_NUMBER>.

    i. FERC Contact: David Rudisail,<PHONE_NUMBER>,

<EMAIL_ADDRESS>     j. Deadline for filing comments, motions to intervene, protests,

and recommendations is 30 days from the issuance date of this notice by

the Commission. The Commission strongly encourages electronic filing.

Please file motions to intervene, protests, comments, or

recommendations using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief

comments up to 6,000 characters, without prior registration, using the

eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You

must include your name and contact information at the end of your

comments. For assistance, please contact FERC Online Support at

<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-

8659 (TTY). In lieu of electronic filing, please send a paper copy to:

Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,

Washington, DC 20426. Please include the project number (P-2771-014, P-

2766-012, or P-2768-012) on any comments, motions to intervene,

protests, or recommendations filed.

    k. Description of Request: The projects have deteriorated to the

point that they can no longer be operated safely. The City of Holyoke

has determined that the cost of repairing the projects is not

economically feasible, and therefore, petitioned to surrender the

licenses for all three projects. The City of Holyoke proposes to shut

and secure all gated intake rack structures with concrete, permanently

close all tailgate area gates, and disconnect all generating equipment

from the projects.

    l. Locations of the Application: A copy of the application is

available for inspection and reproduction at the Commission's Public

Reference Room, located at 888 First Street NE., Room 2A, Washington,

DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed

on the Commission's Web site at http://www.ferc.gov/docs-filing/efiling.asp. Enter the docket number excluding the last three digits in

the docket number field to access the document. You may also register

online at http://www.ferc.gov/docs-filing/esubscription.asp to be

notified via email of new filings and issuances related to this or

other pending projects. For assistance, call 1-866-208-3676 or email

<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item

(h) above.

    m. Individuals desiring to be included on the Commission's mailing

list should so indicate by writing to the Secretary of the Commission.

    n. Comments, Protests, or Motions To Intervene: Anyone may submit

comments, a protest, or a motion to intervene in accordance with the

requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,

.214. In determining the appropriate action to take, the Commission

will consider all protests or other comments filed, but only those who

file a motion to intervene in accordance with the Commission's Rules

may become a party to the proceeding. Any comments, protests, or

motions to intervene must be received on or before the specified

comment date for the particular application.

    o. Filing and Service of Responsive Documents: Any filing must (1)

bear in all capital letters the title Comments, Protest, or Motion To

Intervene, as applicable; (2) set forth in the heading the name of the

applicant and the project number of the application to which the filing

responds; (3) furnish the name, address, and telephone number of the

person protesting or intervening; and (4) otherwise comply with the

requirements of 18 CFR 385.2001 through 385.2005. All comments, motions

to intervene or protests must set forth their evidentiary basis and

otherwise comply with the requirements of 18 CFR 4.34(b). All comments,

motions to intervene or protests should relate to project works which

are the subject of the license proposed re-development. Agencies may

obtain copies of the application directly from the applicant. A copy of

any protest or motion to intervene must be served upon each

representative of the applicant specified in the particular

application. If an intervener files comments or documents with the

Commission relating to the merits of an issue that may affect the

responsibilities of a particular resource agency, they must also serve

a copy of the document on that resource agency. A copy of all other

filings in reference to this application must be accompanied by proof

of service on all persons listed in the service list prepared by the

Commission in this proceeding, in accordance with 18 CFR 4.34(b) and

385.2010.

    Dated: August 14, 2017.

Kimberly D. Bose,

Secretary.

[FR Doc. 2017-17460 Filed 8-17-17; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)]
[Notices]
[Pages 47379-47380]
[FR Doc No: 2016-17219]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-479-000]

Columbia Gas Transmission, LLC; Notice of Request Under Blanket
Authorization

    Take notice that on July 11, 2016, Columbia Gas Transmission, LLC
(Columbia), pursuant to its blanket certificate authorization granted
in Docket No. CP83-76-000,\1\ filed an application in accordance to
sections 157.205 and 157.213(b) of the Commission's Regulations under
the Natural Gas Act (NGA) as amended, requesting authority to modify
certain natural gas storage facilities in the Pavonia Storage Field
located in Ashland County, Ohio (Pavonia). The proposed construction is
an effort to recovery the overall field deliverability at the Pavonia,
all as more fully set forth in the application which is on file with
the Commission and open to public inspection.
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    \1\ 22 FERC ] 62,029 (1983).
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    Currently, the Pavonia consists of 298 active wells and 2
observation wells and is operated with a total storage capacity of 45.4
Bcf, including 20.8 Bcf of base gas and 24.6 Bcf of working gas. Over
time, the sub grade soil conditions around the reservoir degrade and
cause restriction of gas flow through the existing vertical wells.
Columbia proposes to construct a 540-foot horizontal well (Pavonia
12595) within a geological-favorable area of the Pavonia peaking group,
220 feet of 6-inch storage pipeline (SLW-12595), and appurtenances. The
main purpose of the proposed facilities is to maintain field
performance late in the withdrawal season when reservoir pressure is
lowest. It is estimated that the new horizontal well will provide 25
MMcf/day at the wellhead. Columbia's request seeks no change in the
certificated physical parameters, including total inventory, reservoir
pressure, and capacity. The construction of the proposed facilities
will cost approximately $2,750,000.
    Any questions concerning this application may be directed to
Matthew J. Agen, Senior Counsel, Columbia Gas Transmission, LLC, 5151
San Felipe, Suite 2400, Houston, Texas 77056, or by phone at (713) 386-
3619; email<EMAIL_ADDRESS>    This filing is available for review at the Commission or may be
viewed on the Commission's Web site at http://www.ferc.gov, using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number filed to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or call toll-free at<PHONE_NUMBER>, or, for
TTY, contact<PHONE_NUMBER>. Comments, protests and interventions may
be filed electronically via the Internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
interveners to file electronically.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice, the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to section 157.205 of
the regulations under the

NGA (18 CFR 157.205), a protest to the request. If no protest is filed
within the time allowed therefore, the proposed activity shall be
deemed to be authorized effective the day after the time allowed for
filing a protest. If a protest is filed and not withdrawn within 30
days after the allowed time for filing a protest, the instant request
shall be treated as an application for authorization pursuant to
section 7 of the NGA.

    Dated: July 15, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-17219 Filed 7-20-16; 8:45 am]
 BILLING CODE 6717-01-P