[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Notices]
[Pages 44626-44628]
[FR Doc No: 2017-20391]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-M-4474, FDA-2016-M-1915, FDA-2016-M-1837, FDA-
2016-M-1916, FDA-2016-M-1914, FDA-2016-M-1917, FDA-2016-M-2182, FDA-
2016-M-2183, FDA-2016-M-2184, FDA-2016-M-2185, FDA-2016-M-2332, FDA-
2016-M-2334, FDA-2016-M-2333, FDA-2016-M-2485, FDA-2016-M-2498, FDA-
2016-M-2499, FDA-2016-M-2500, FDA-2016-M-2649, FDA-2016-M-2650, FDA-
2016-M-2651, FDA-2016-M-2735, FDA-2016-M-2974, FDA-2016-M-2971, FDA-
2016-M-1972, FDA-2016-M-2973, FDA-2016-M-2975, FDA-2016-M-3430, FDA-
2016-M-3431, FDA-2016-M-3913, FDA-2016-M-3653, FDA-2016-M-3914, FDA-
2016-M-3915, FDA-2016-M-4046, FDA-2016-M-4344, FDA-2016-M-4458, FDA-
2016-M-4459, FDA-2016-M-4483, FDA-2016-M-4657, FDA-2016-M-4530, FDA-
2016-M-4653, FDA-2017-M-0180, FDA-2017-M-0181, FDA-2017-M-0229, FDA-
2017-M-0560, FDA-2017-M-0831, FDA-2017-M-0661, FDA-2017-M-0971, FDA-
2017-M-2652, FDA-2017-M-1121, FDA-2017-M-1122, FDA-2017-M-1228, FDA-
2017-M-1845, FDA-2017-M-1227, FDA-2017-M-1713, FDA-2017-M-1714, FDA-
2017-M-1950, FDA-2017-M-2594, FDA-2017-M-2766, FDA-2017-M-2767, FDA-
2017-M-2768, FDA-2017-M-3103, FDA-2017-M-3200, FDA-2017-M-3430, FDA-
2017-M-3579, FDA-2017-M-3580, FDA-2017-M-3778, FDA-2017-M-3839, FDA-
2017-M-3928, FDA-2017-M-3982, FDA-2017-M-3990, and FDA-2017-M-3983]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

ADDRESSES: You may submit comments 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 Nos.
FDA-2015-M-4474, FDA-2016-M-1915, FDA-2016-M-1837, FDA-2016-M-1916,
FDA-2016-M-1914, FDA-2016-M-1917, FDA-2016-M-2182, FDA-2016-M-2183,
FDA-2016-M-2184, FDA-2016-M-2185, FDA-2016-M-2332, FDA-2016-M-2334,
FDA-2016-M-2333, FDA-2016-M-2485, FDA-2016-M-2498, FDA-2016-M-2499,
FDA-2016-M-2500, FDA-2016-M-2649, FDA-2016-M-2650, FDA-2016-M-2651,
FDA-2016-M-2735, FDA-2016-M-2974, FDA-2016-M-2971, FDA-2016-M-1972,
FDA-2016-M-2973, FDA-2016-M-2975, FDA-2016-M-3430, FDA-2016-M-3431,
FDA-2016-M-3913, FDA-2016-M-3653, FDA-2016-M-3914, FDA-2016-M-3915,
FDA-2016-M-4046, FDA-2016-M-4344, FDA-2016-M-4458, FDA-2016-M-4459,
FDA-2016-M-4483, FDA-2016-M-4657, FDA-2016-M-4530, FDA-2016-M-4653,
FDA-2017-M-0180, FDA-2017-M-0181, FDA-2017-M-0229, FDA-2017-M-0560,
FDA-2017-M-0831, FDA-2017-M-0661, FDA-2017-M-0971, FDA-2017-M-2652,
FDA-2017-M-1121, FDA-2017-M-1122, FDA-2017-M-1228, FDA-2017-M-1845,
FDA-2017-M-1227, FDA-2017-M-1713, FDA-2017-M-1714, FDA-2017-M-1950,
FDA-2017-M-2594, FDA-2017-M-2766, FDA-2017-M-2767, FDA-2017-M-2768,
FDA-2017-M-3103, FDA-2017-M-3200, FDA-2017-M-3430, FDA-2017-M-3579,
FDA-2017-M-3580, FDA-2017-M-3778, FDA-2017-M-3839, FDA-2017-M-3928,
FDA-2017-M-3982, FDA-2017-M-3990, and FDA-2017-M-3983 for ``Medical
Devices; Availability of Safety and Effectiveness Summaries for
Premarket Approval Applications.'' 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.

FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the FD&C Act. The
30-day period for requesting reconsideration of an FDA action under
Sec.  10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a
PMA begins on the day the notice is placed on the internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
    The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the internet from July 1, 2016, through June 30, 2017.
There were no denial actions during this period. The list provides the
manufacturer's name, the product's generic name or the trade name, and
the approval date.

 Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From July 1, 2016 Through
                                                  June 30, 2017
----------------------------------------------------------------------------------------------------------------
                                                                                Approval
          PMA No., Docket No.                     Applicant                    Trade name                date
----------------------------------------------------------------------------------------------------------------
P130018, FDA-2015-M-4474...............  Uromedica, Inc............  ProACTTM Adjustable Continence     11/24/15
                                                                      Therapy for Men.
P140003/S004, FDA-2016-M-1915..........  Abiomed, Inc..............  Impella Ventricular Support...     4/7/2016
P150034, FDA-2016-M-1837...............  Revision Optics, Inc......  Raindrop Near Vision Inlay....    6/29/2016
P150017, FDA-2016-M-1916...............  Cartiva, Inc..............  Cartiva Synthetic Cartilage        7/1/2016
                                                                      Implant.
P150023, FDA-2016-M-1914...............  Abbott Vascular...........  Absorb GT1TM Bioresorbable         7/5/2016
                                                                      Vascular Scaffold (BVS)
                                                                      System.
P100020/S017, FDA-2016-M-1917..........  Roche Molecular Systems,    cobas[supreg] HPV Test........     7/7/2016
                                          Inc.
P090029/S003, FDA-2016-M-2182..........  Medtronic Sofamor Danek     Prestige LPTM Cervical Disc...     7/7/2016
                                          USA, Inc.
P150038, FDA-2016-M-2183...............  InSightec, Inc............  ExAblate Model 4000 Type 1.0      7/11/2016
                                                                      System (ExAblate Neuro).
P980040/S065, FDA-2016-M-2184..........  Abbott Medical Optics, Inc  TECNIS[supreg] Symfony            7/15/2016
                                                                      Extended Range of Vision
                                                                      Intraocular Lens.
P150006, FDA-2016-M-2185...............  Vasorum, Ltd..............  Celt ACD Vascular Closure         7/20/2016
                                                                      Device.
P160004, FDA-2016-M-2332...............  W.L. Gore & Associates,     Gore TIGRIS Vascular Stent....    7/27/2016
                                          Inc.
P150003/S003, FDA-2016-M-2334..........  Boston Scientific Corp....  SYNERGYTM Everolimus-Eluting      7/29/2016
                                                                      Platinum Chromium Coronary
                                                                      Stent System (Over-The-Wire &
                                                                      Monorail).
P150037, FDA-2016-M-2333...............  Alcon Laboratories, Inc...  CyPass[supreg] System (Model      7/29/2016
                                                                      241-S).
P150001, FDA-2016-M-2500...............  Medtronic MiniMed.........  MiniMed 630G System with          8/10/2016
                                                                      SmartGuard.
P150036, FDA-2016-M-2485...............  Edwards Lifesciences, LLC.  Edwards INTUITY Elite Valve       8/12/2016
                                                                      System.
P130009/S057, FDA-2016-M-2498..........  Edwards Lifesciences LLC..  Edwards SAPIEN XT                 8/18/2016
                                                                      Transcatheter Heart Valve.
P140031/S010, FDA-2016-M-2499..........  Edwards Lifesciences LLC..  Edwards SAPIEN 3 Transcatheter    8/18/2016
                                                                      Heart Valve.
P020045/S073, 2016-M-2649..............  Medtronic, Inc............  Freezor[supreg] Xtra Cardiac      8/31/2016
                                                                      Cryoablation Catheter.
P140010/S015, FDA-2016-M-2650..........  Medtronic Vascular, Inc...  In PactTM AdmiralTM Paclitaxel-    9/7/2016
                                                                      Coated Percutaneous
                                                                      Transluminal Angioplasty
                                                                      Balloon Catheter.
P160001, FDA-2016-M-2651...............  Obalon Therapeutics, Inc..  Obalon Balloon System.........     9/8/2016
P150040, FDA-2016-M-2735...............  Carl Zeiss Meditec, Inc...  VisuMax[supreg] Femtosecond       9/13/2016
                                                                      Laser.
P000025/S084, FDA-2016-M-2974..........  MED-EL Corp...............  MED-EL Cochlear Implant System    9/15/2016
P150021, FDA-2016-M-2971...............  Abbott Diabetes Care, Inc.  Freestyle Libre Pro Flash         9/23/2016
                                                                      Glucose Monitoring System.
P080020/S020, FDA-2016-M-2975..........  Seikagaku Corp............  Gel-One[supreg]...............    9/27/2016
P160017, FDA-2016-M-1972...............  Medtronic MiniMed, Inc....  MiniMed 670G System...........    9/28/2016
P150044, FDA-2016-M-2973...............  Roche Molecular Systems,    cobas[supreg] EGFR Mutation       9/28/2016
                                          Inc.                        Test v2.
P150030, FDA-2016-M-3430...............  Smith & Nephew, Inc.......  R3TM delta Ceramic Acetabular    10/17/2016
                                                                      System.
P160006, FDA-2016-M-3431...............  Ventana Medical Systems,    VENTANA PD-L1 (SP142) Assay...   10/18/2016
                                          Inc.
P150013/S001, FDA-2016-M-3913..........  Dako North America, Inc...  PD-L1 IHC 22C3 pharmDX........   10/24/2016
P120021, FDA-2016-M-3653...............  St. Jude Medical, Inc.....  AmplatzerTM PFO Occluder......   10/28/2016
P150043, FDA-2016-M-3914...............  QView Medical, Inc........  QVCAD System..................    11/9/2016
P930016/S045, FDA-2016-M-3915..........  AMO Manufacturing USA, LLC  Star S4 IR Excimer Laser         11/14/2016
                                                                      System and iDesign Advanced
                                                                      WaveScan Studio.
P020050/S023, FDA-2016-M-4046..........  Alcon Laboratories, Inc...  WaveLight[supreg] EX500 and      11/21/2016
                                                                      ALLEGRETTO WAVE[supreg] EYE-Q
                                                                      Excimer Laser Systems.
P140029, FDA-2016-M-4344...............  Q-Med AB..................  Restylane[supreg] Refyne and      12/9/2016
                                                                      Restylane[supreg] Defyne.
P130007/S016, FDA-2016-M-4458..........  Animas Corporation........  OneTouch VibeTM Plus System...   12/16/2016
P160018, FDA-2016-M-4459...............  Foundation Medicine, Inc..  FoundationFocusTM CDxBRACA       12/19/2016
                                                                      Assay.
P120005/S041, FDA-2016-M-4483..........  Dexcom, Inc...............  Dexcom G5 Mobile Continuous      12/20/2016
                                                                      Glucose Monitoring System.
P040020/S049, FDA-2016-M-4657..........  Alcon Laboratories, Inc...  Acrysof[supreg] IQ               12/22/2016
                                                                      ReSTOR[supreg] +3.0 D
                                                                      Multifocal Toric Intraocular
                                                                      Lens.
P160019, FDA-2016-M-4530...............  Roche Diagnostics.........  Elecsys HBsAg II/Elecsys HBsAg   12/23/2016
                                                                      Confirmatory Test/
                                                                      PreciControl HBsAg II.
P100022/S020, FDA-2016-M-4653..........  Cook Medical Inc..........  Zilver PTX Drug-Eluting          12/28/2016
                                                                      Peripheral Stent.
H070005, FDA-2017-M-0180...............  AGA Medical Corp..........  AMPLATZERTM Post-Infarct          1/10/2017
                                                                      Muscular VSD Occluder.
P160031, FDA-2017-M-0181...............  FUJIFILM Medical Systems    ASPIRE Cristalle Digital          1/10/2017
                                          U.S.A., Inc.                Breast Tomosynthesis Option.
P160008, FDA-2017-M-0229...............  HeartSine Technologies LLC  HeartSine samaritan[supreg]       1/12/2017
                                                                      SAM 350P, SAM 360P, and SAM
                                                                      450P Public Access Automated
                                                                      External Defibrillators,
                                                                      Accessories and Saver
                                                                      EVO[supreg] Software Version
                                                                      1.4.0.
P160021, FDA-2017-M-0560...............  W.L. Gore & Associates,     Gore[supreg] Viabahn[supreg]      1/27/2017
                                          Inc.                        VBX Balloon Expandable
                                                                      Endoprosthesis.
P130024/S009, FDA-2017-M-0831..........  Lutonix, Inc..............  Lutonix[supreg] 035 Drug           2/7/2017
                                                                      Coated Balloon PTA Catheter.
P140033, FDA-2017-M-0661...............  St. Jude Medical, Inc.....  MR Conditional Pacemaker          1/31/2017
                                                                      System--Assurity MRITM and
                                                                      Endurity MRITM Pacemakers and
                                                                      Tendril MRITM 1200M LPA Lead.
P160023, FDA-2017-M-0971...............  Hologic, Inc..............  Aptima[supreg] HCV Quant Dx       2/13/2017
                                                                      Assay.

P160003, FDA-2016-M-2652...............  Biotronik, Inc............  PRO-Kinetic Energy Cobalt         2/14/2017
                                                                      Chromium Coronary Stent
                                                                      System.
P150039, FDA-2017-M-1121...............  Tryton Medical, Inc.......  TRYTON Side Branch Stent......    2/21/2017
P160014, FDA-2017-M-1122...............  CeloNova BioSciences, Inc.  COBRA PzFTM NanoCoated            2/21/2017
                                                                      Coronary Stent System.
P100044/S023, FDA-2017-M-1228..........  Intersect ENT.............  PROPEL[supreg] Contour Sinus      2/23/2017
                                                                      Implant.
P140017/S005, FDA-2017-M-1227..........  Medtronic, Inc............  MelodyTM Transcatheter            2/24/2017
                                                                      Pulmonary Valve, EnsembleTM
                                                                      Transcatheter Valve Delivery
                                                                      System and EnsembleTM II
                                                                      Transcatheter Valve Delivery
                                                                      System.
P160016, FDA-2017-M-1713...............  Siemens Healthcare          VERSANT[supreg] HCV GENOTYPE      3/14/2017
                                          Diagnostics, Inc.           2.0 Assay (LiPA).
P110033/S020, FDA-2017-M-1714..........  Allergan..................  Juv[eacute]derm VollureTM XC..    3/17/2017
P160025, FDA-2017-M-1845...............  Biotronik, Inc............  Astron Pulsar and Pulsar-18       3/23/2017
                                                                      Stent Systems.
P160009, FDA-2017-M-1950...............  iCAD, Inc.................  PowerLook[supreg] Tomo            3/24/2017
                                                                      Detection Software.
P160024, FDA-2017-M-2594...............  Bard Peripheral Vascular,   LifeStream Balloon Expandable     4/24/2017
                                          Inc.                        Vascular Covered Stent.
P160043, FDA-2017-M-2767...............  Medtronic, Inc............  Resolute Onyx Zotarolimus-        4/28/2017
                                                                      Eluting Coronary Stent System.
P160040, FDA-2017-M-2766...............  Invivoscribe Technologies,  LeukoStrat[supreg] CDx FLT3       4/28/2017
                                          Inc.                        Mutation Assay.
P160046, FDA-2017-M-2768...............  Ventana Medical Systems,    VENTANA PD-L1 (SP263) Assay...     5/1/2017
                                          Inc.
H150003, FDA-2017-M-3103...............  Wilson-Cook Medical, Inc..  FlourishTM Pediatric              5/12/2017
                                                                      Esophageal Atresia Device.
P160044, FDA-2017-M-3200...............  Abbott Molecular, Inc.....  Abbott RealTime CMV...........    5/18/2017
P160041, FDA-2017-M-3430...............  Roche Molecular Systems,    cobas[supreg] CMV.............     6/1/2017
                                          Inc.
P140031/S028, FDA-2017-M-3579..........  Edwards Lifesciences LLC..  Edwards SAPIEN 3TM                 6/5/2017
                                                                      Transcatheter Heart Valve and
                                                                      Accessories.
P160035, FDA-2017-M-3580...............  Berlin Heart, Inc.........  EXCOR[supreg] Pediatric            6/6/2017
                                                                      Ventricular Assist Device.
P160047, FDA-2017-M-3778...............  AEGEA Medical, Inc........  AEGEA Vapor SystemTM..........    6/14/2017
H160002, FDA-2017-M-3839...............  Pulsar Vascular, Inc......  PulseRider[supreg] Aneurysm       6/19/2017
                                                                      Neck Reconstruction Device
                                                                      (``PulseRider'').
P160045, FDA-2017-M-3928...............  Life Technologies Corp....  OncomineTM Dx Target Test.....    6/22/2017
P150046, FDA-2017-M-3982...............  SciBase AB................  Nevisense.....................    6/28/2017
P150048, FDA-2017-M-3990...............  Edwards Lifesciences, LLC.  Edwards Pericardial Aortic        6/29/2017
                                                                      Bioprosthesis and Edwards
                                                                      INSPIRIS RESILIA Aortic Valve.
P160038, FDA-2017-M-3983...............  Illumina, Inc.............  PraxisTM Extended RAS Panel...    6/29/2017
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.

    Dated: September 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20391 Filed 9-22-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Notices]
[Pages 31057-31059]
[FR Doc No: 2012-12620]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67027; File No. SR-NASDAQ-2012-061]

Self-Regulatory Organizations; the NASDAQ Stock Market LLC;
Notice of Filing of Proposed Rule Change for the NASDAQ Options Market
To Accept Inbound Orders From NASDAQ OMX BX's New Options Market

 May 18, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 15, 2012, The NASDAQ Stock Market LLC (``Exchange'' or
``NASDAQ'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    NASDAQ is filing with the Commission a proposal for the NASDAQ
Options Market (``NOM'') to accept inbound orders routed by NASDAQ
Options Services LLC (``NOS'') from NASDAQ OMX BX's new options market
(with the attendant obligations and conditions), as described further
below, on a one year pilot basis.
    The text of the proposed rule change is available at http://nasdaq.cchwallstreet.com, at NASDAQ's principal office, and at the
Commission's Public Reference Room.

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

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

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

1. Purpose
    In conjunction with a proposal by NASDAQ OMX BX (``BX'') to
establish a new options market and provide outbound routing services to
all markets using its affiliated routing broker, NOS,\3\ NASDAQ
proposes that NOS be permitted to route orders from BX to NASDAQ on a
one year pilot basis.
---------------------------------------------------------------------------

    \3\ See SR-BX-2012-030.
---------------------------------------------------------------------------

    NOS is a broker-dealer and member of NASDAQ, BX and NASDAQ OMX PHLX
(``PHLX''). NOS provides all routing functions for NASDAQ \4\ and

PHLX,\5\ and BX has proposed that NOS do so for BX as well.\6\ NASDAQ,
PHLX, BX and NOS are affiliates. Accordingly, the affiliate
relationship between NASDAQ and NOS, its member, raises the issue of an
exchange's affiliation with a member of such exchange.\7\ Specifically,
in connection with prior filings, the Commission has expressed concern
that the affiliation of an exchange with one of its members raises the
potential for unfair competitive advantage and potential conflicts of
interest between an exchange's self-regulatory obligations and its
commercial interests.\8\
---------------------------------------------------------------------------

    \4\ See NOM Rules Chapter VI, Section 11(e). See also Securities
Exchange Act Release No. 57478 (March 12, 2008), 73 FR 14521 (March
18, 2008) (SR-NASDAQ-2007-004 and SR-NASDAQ-2007-080).
    \5\ See Securities Exchange Act Release No. 59995 (May 28,
2009), 74 FR 26750 (June 3, 2009) (SR-Phlx-2009-32).
    \6\ See SR-BX-2012-030.
    \7\ Absent an effective filing, Exchange Rule 2160(b) would
prohibit NOS from being a member of the Exchange.
    \8\ See e.g., Securities Exchange Act Release No. 59153
(December 23, 2008), 73 FR 80485 (December 31, 2008) (SR-NASDAQ-
2008-098); and 62736 (August 17, 2010), 75 FR 51861 (August 23,
2010) (SR-NASDAQ-2010-100).
---------------------------------------------------------------------------

    Recognizing that the Commission has previously expressed concern
regarding the potential for conflicts of interest in instances where a
member firm is affiliated with an exchange of which it is a member,
NASDAQ previously proposed, and the Commission approved, limitations
and conditions on NOS's affiliation with NASDAQ.\9\ In addition, NASDAQ
is permitted to accept inbound orders that NOS routes in its capacity
as a facility of PHLX, subject to certain limitations and
conditions.\10\
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release No. 57478 (March 12,
2008), 73 FR 14521 (March 18, 2008) (SR-NASDAQ-2007-004 and SR-
NASDAQ-2007-080).
    \10\ See Securities Exchange Act Release No. 59948 (May 20,
2009), 74 FR 25784 (May 29, 2009) (SR-NASDAQ-2009-047).
---------------------------------------------------------------------------

    Also recognizing that the Commission has expressed concern
regarding the potential for conflicts of interest in instances where a
member firm is affiliated with an exchange to which it is routing
orders, many exchanges have filed with the Commission the conditions
and limitations under which they can accept inbound orders from an
affiliated exchange using an affiliated router.\11\ At this time,
NASDAQ proposes to accept inbound options orders that NOS will route in
its capacity as a facility of BX, subject to the following limitations
and conditions:
---------------------------------------------------------------------------

    \11\ See e.g., Securities Exchange Act Release No. 65399
(September 26, 2011), 76 FR 60955 (September 20, 2011) (SR-Phlx-
2011-111).
---------------------------------------------------------------------------

     First, NASDAQ and the Financial Industry Regulatory
Authority (``FINRA'') will maintain a Regulatory Contract, as well as
an agreement pursuant to Rule 17d-2 under the Act (``17d-2
Agreement'').\12\ Pursuant to the Regulatory Contract and the 17d-2
Agreement, FINRA will be allocated regulatory responsibilities to
review NOS's compliance with certain NASDAQ rules.\13\ Pursuant to the
Regulatory Contract, however, NASDAQ retains ultimate responsibility
for enforcing its rules with respect to NOS.
---------------------------------------------------------------------------

    \12\ 17 CFR 240.17d-2.
    \13\ NOS is also subject to independent oversight by FINRA, its
designated examining authority, for compliance with financial
responsibility requirements.
---------------------------------------------------------------------------

     Second, FINRA will monitor NOS for compliance with
NASDAQ's trading rules, and will collect and maintain certain related
information.\14\
---------------------------------------------------------------------------

    \14\ Pursuant to the Regulatory Contract, both FINRA and NASDAQ
will collect and maintain all alerts, complaints, investigations and
enforcement actions in which NOS (in its capacity as a facility of
BX routing orders to NASDAQ) is identified as a participant that has
potentially violated applicable Commission or Exchange rules. NASDAQ
and FINRA will retain these records in an easily accessible manner
in order to facilitate any potential review conducted by the
Commission's Office of Compliance Inspections and Examinations.
---------------------------------------------------------------------------

     Third, FINRA will provide a report to NASDAQ's chief
regulatory officer (``CRO''), on a quarterly basis, that: (i)
Quantifies all alerts (of which the Exchange or FINRA is aware) that
identify NOS as a participant that have potentially violated Commission
or Exchange rules, and (ii) lists all investigations that identify NOS
as a participant that has potentially violated Commission or Exchange
rules.
     Fourth, NASDAQ is amending NASDAQ Rule 2160 \15\ to
require NASDAQ OMX, as the holding company owning both NASDAQ and NOS,
to establish and maintain procedures and internal controls reasonably
designed to ensure that NOS does not develop or implement changes to
its system, based on non-public information obtained regarding planned
changes to NASDAQ's systems as a result of its affiliation with NASDAQ,
until such information is available generally to similarly situated
Exchange members, in connection with the provision of inbound order
routing to NASDAQ. Currently, Rule 2160 applies to NES; NASDAQ proposes
to add NOS to this rule.
---------------------------------------------------------------------------

    \15\ Currently, NASDAQ Rule 2160 requires NASDAQ OMX, as the
holding company owning both NASDAQ and NASDAQ Execution Services,
LLC (``NES''), to establish and maintain procedures and internal
controls reasonably designed to ensure that NES does not develop or
implement changes to its system, based on non-public information
obtained regarding planned changes to NASDAQ's systems as a result
of its affiliation with NASDAQ, until such information is available
generally to similarly situated Exchange members, in connection with
the provision of inbound order routing to NASDAQ.
---------------------------------------------------------------------------

     Fifth, NASDAQ proposes that the routing of orders from NOS
to NASDAQ, in NOS's capacity as a facility of BX be authorized for a
pilot period of one year.
    NASDAQ believes that the above-listed conditions protect the
independence of NASDAQ's regulatory responsibility with respect to NOS,
and that these mitigate the aforementioned concerns about potential
conflicts of interest and unfair competitive advantage.
2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\16\ in general, and with
Section 6(b)(5) of the Act,\17\ in particular, in that the proposal is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, 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, because the
proposed rule change will allow NASDAQ to receive inbound routes of
orders from NOS, acting in its capacity as a facility of BX, in a
manner consistent with prior approvals and established protections.
NASDAQ believes that the proposed conditions establish mechanisms that
protect the independence of NASDAQ's regulatory responsibility with
respect to NOS, as well as ensure that NOS cannot use any information
it may have because of its affiliation with NASDAQ to its advantage.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f.
    \17\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    No written comments were either solicited or received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    A. By order approve or disapprove such proposed rule change; or
    B. Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2012-061 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2012-061. 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 Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2012-061 and should
be submitted on or before June 14, 2012.
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority. \18\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-12620 Filed 5-23-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 110 (Monday, June 9, 2014)]
[Proposed Rules]
[Pages 32881-32883]
[FR Doc No: 2014-13261]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 79, No. 110 / Monday, June 9, 2014 / Proposed
Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0364; Directorate Identifier 2013-SW-041-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters (Previously
Eurocopter France) (Airbus Helicopters) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede airworthiness directive (AD) 2013-21-
01 that currently applies to Eurocopter France Model AS350B, AS350BA,
AS350B1, AS350B2, AS350B3, AS350C, AS350D, AS350D1, AS355E, AS355F,
AS355F1, AS355F2, AS355N, and AS355NP helicopters. AD 2013-21-01
currently requires certain inspections of each tail rotor pitch horn
assembly (pitch horn) for a crack and, if there is a crack, before
further flight, replacing the pitch horn with an airworthy pitch horn.
AD 2013-21-01 also requires a one-time visual inspection for pitch
horns above certain hours time-in-service (TIS). This NPRM would retain
the requirements of AD 2013-21-01 but would require a repetitive visual
inspection for all pitch horns regardless of hours TIS, which requires
allowing the public an opportunity to comment. These proposed actions
are intended to detect a crack in the pitch horn to prevent failure of
the pitch horn, loss of the anti-torque function, and subsequent loss
of control of the helicopter.

DATES: We must receive comments on this proposed AD by August 8, 2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the foreign
authority's AD, the economic evaluation, any comments received and
other information. The street address for the Docket Operations Office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.
    For service information identified in this proposed AD, contact
Airbus Helicopters, Inc., 2701 N. Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
http://www.airbushelicopters.com/techpub.
    You may review the referenced service information at the FAA,
Office of the Regional Counsel, Southwest Region, 2601 Meacham Blvd.,
Room 663, Fort Worth, Texas 76137.

FOR FURTHER INFORMATION CONTACT: Robert Grant, Aviation Safety
Engineer, Safety Management Group, FAA, 2601 Meacham Blvd., Fort Worth,
Texas 76137; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    On October 7, 2013, we issued AD 2013-21-01, Amendment 39-17625 (78
FR 63853, October 25, 2013) for Eurocopter France (now Airbus
Helicopters) Model AS350B, AS350BA, AS350B1, AS350B2, AS350B3, AS350C,
AS350D, AS350D1, AS355E, AS355F, AS355F1, AS355F2, AS355N, and AS355NP
helicopters. AD 2013-21-01 requires a one-time visual inspection of
each pitch horn with 135 or more hours TIS for a crack and, if there is
a crack, before further flight, replacing the pitch horn with an
airworthy pitch horn. It also requires a dye-penetrant inspection of
any pitch horn before it is installed. AD 2013-21-01 was prompted by a
report of a crack in the yoke of a pitch horn and is intended to detect
a crack in the pitch horn to prevent failure of the pitch horn, loss of
the anti-torque function, and subsequent loss of control of the
helicopter.
    AD 2013-21-01 was prompted by AD No. 2013-0133, dated June 28,
2013, issued by the European Aviation Safety Agency (EASA), which is
the Technical Agent for the Member States of the European Union. EASA
issued AD No. 2013-0133 to correct an unsafe condition for Model
AS350B, AS350BA, AS350BB, AS350B1, AS350B2, AS350B3, AS350D, AS355E,
AS355F, AS355F1, AS355F2, AS355N, and AS355NP helicopters. EASA advises
of an ongoing investigation of a crack in the yoke of a pitch horn for
which a cause has not been determined. The EASA AD requires repetitive
visual inspections of each pitch horn for a crack and replacing the
pitch horn with a serviceable assembly if a crack is found. EASA states
that its AD is an

interim action and further action may follow.
    This NPRM would retain the actions in AD 2013-12-01 but would
require the visual inspection for all pitch horns regardless of hours
TIS. This NPRM would also require repeating the visual inspection every
165 hours TIS. This NPRM would also change the requirement for the dye
penetration inspection so that it only applies to pitch horns that are
not new. Also, since we issued AD 2013-12-01, Eurocopter France has
changed its name to Airbus Helicopters. This NPRM reflects that change.

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, its technical
representative, has notified us of the unsafe condition described in
the EASA AD. We are proposing this AD because we evaluated all known
relevant information and determined that an unsafe condition is likely
to exist or develop on other helicopters of the same type design.

Related Service Information

    We reviewed a Eurocopter (now Airbus Helicopters) Emergency Alert
Service Bulletin, Revision 1, dated June 25, 2013 (EASB), with four
different numbers. EASB No.05.00.74 is for Model AS350B, B1, B2, B3,
BA, and D; the non-FAA type certificated Model AS350BB; and the non-FAA
type certificated military Model AS350L1 helicopters. EASB No. 05.00.49
is for non-FAA type certificated military Model AS550A2, C2, C3, and U2
helicopters. EASB No. 05.00.65 is for Model AS355E, F, F1, F2, N, and
NP helicopters. EASB No. 05.00.44 is for non-FAA type certificated
military Model AS555AF, AN, SN, UF, and UN helicopters. Airbus
Helicopters has been informed of a case of a crack on the yoke of a
pitch horn, which may lead to failure of the pitch horn, resulting in
loss of the anti-torque function. The EASB specifies a check for cracks
on the yokes of the two pitch horns and specifies replacing any cracked
pitch horn. The EASB states that it may be necessary to modify the log
card of the tail rotor blade assembly due to some of the pitch horn
part numbers being recorded incorrectly.
    EASA classified this EASB as mandatory and issued EASA AD No. 2013-
0133, dated June 28, 2013, to ensure the continued airworthiness of
these helicopters.

Proposed AD Requirements

    This proposed AD would require:
     For parts with 155 or less hours TIS, before exceeding 165
hours TIS, or for parts with more than 155 hours TIS, within 10 hours
TIS, visually inspecting each pitch horn for a crack.
     Thereafter, at intervals not to exceed 165 hours TIS,
visually inspecting each pitch horn for a crack.
     After each inspection, if there is a crack, before further
flight, replacing the pitch horn with an airworthy pitch horn.
     Before installing any pitch horn, P/N 350A121368, with
more than 0 hours TIS, dye penetrant inspecting it for a crack.

Differences Between the Proposed AD and the EASA AD

    The EASA AD applies to Eurocopter Model AS350BB that does not have
an FAA type certificate and therefore is not a part of this proposed
AD. The EASA AD does not apply to Eurocopter Model AS350C or AS350D1,
but this proposed AD would because those models have an FAA type
certificate and may have the applicable pitch horn installed. The
proposed AD would require a dye-penetrant inspection before installing
a pitch horn; the EASA AD does not.

Interim Action

    We consider this AD to be an interim action. If final action is
later identified, we might consider further rulemaking then.

Costs of Compliance

    We estimate that this proposed AD would affect 938 helicopters of
U.S. Registry. We estimate that operators may incur the following costs
in order to comply with this proposed AD. Labor costs are estimated at
$85 per work hour. We estimate .1 work hour to visually inspect a pitch
horn for a total cost of $8.50 per helicopter or $7,973 for the fleet,
per inspection cycle. We estimate 1 work hour to do a dye-penetrant
inspection, for a total cost of $85 per helicopter. We estimate 1 work
hour to replace a part, if necessary, and a cost for required parts of
$1,946, for a total cost of $2,031 per helicopter.

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

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; 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.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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 removing airworthiness directive (AD)
2013-21-01, Amendment 39-17625 (78 FR 63853, October 25, 2013), Docket
No. FAA-2013-0878, Directorate Identifier

2013-SW-033-AD, and adding the following new AD:

Airbus Helicopters (Previously Eurocopter France Helicopters)
(Airbus Helicopters): Docket No. FAA-2014-0364; Directorate
Identifier 2013-SW-041-AD.

(a) Applicability

    This AD applies to Airbus Helicopters Model AS350B, AS350BA,
AS350B1, AS350B2, AS350B3, AS350C, AS350D, AS350D1, AS355E, AS355F,
AS355F1, AS355F2, AS355N, and AS355NP helicopters with tail rotor
hub pitch horn (pitch horn) assembly, part number (P/N)
350A121368.01, 350A121368.02, 350A121368.03, or 350A121368.04, with
a pitch horn, P/N 350A121368.XX, where XX stands for a two-digit
dash number, installed, certificated in any category. The pitch horn
may be marked with either the pitch horn assembly P/N or pitch horn
P/N.

(b) Unsafe Condition

    This AD defines the unsafe condition a crack in the yoke of a
pitch horn. This condition could result in failure of a pitch horn,
loss of the anti-torque function, and subsequent loss of control of
the helicopter.

(c) Affected ADs

    This AD supersedes AD 2013-21-01, Amendment 39-17625 (78 FR
63853, October 25, 2013).

(d) Comments Due Date

    We must receive comments by August 8, 2014.

(e) 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.

(f) Required Actions

    (1) For parts with 155 or less hours time-in-service (TIS),
before exceeding 165 hours TIS, or for parts with more than 155
hours TIS, within 10 hours TIS, and thereafter at intervals not to
exceed 165 hours TIS, visually inspect each pitch horn for a crack
in the areas shown in Figure 1 of Eurocopter Emergency Alert Service
Bulletin (EASB) No. 05.00.74 or No. 05.00.65, both Revision 1 and
both dated June 25, 2013, as appropriate for your model helicopter.
    (2) If there is a crack, before further flight, replace the
pitch horn with an airworthy pitch horn.
    (3) Do not install a pitch horn, P/N 350A121368 (any dash
number), with more than 0 hours TIS on any helicopter unless it has
passed a dye penetrant inspection for a crack in the areas shown in
Figure 1 of Eurocopter EASB No. 05.00.74 or No. 05.00.65, both
Revision 1 and both dated June 25, 2013, as appropriate for your
model helicopter.

(g) Special Flight Permits

    Special flight permits are prohibited.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Robert Grant, Aviation Safety
Engineer, Safety Management Group, FAA, 2601 Meacham Blvd., Fort
Worth, Texas 76137; 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.

(i) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) AD No. 2013-0133, dated June 28, 2013. You may view
the EASA AD on the Internet at http://www.regulations.gov in Docket
No. FAA-2014-0364.

(j) Subject

    Joint Aircraft Service Component (JASC) Code: 6400 Tail Rotor.

    Issued in Fort Worth, Texas, on May 30, 2014.
Lance T. Gant,
Acting Directorate Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 2014-13261 Filed 6-6-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80218-80219]
[FR Doc No: 2020-27213]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2013-0444; FMCSA-2014-0212; FMCSA-2015-0320; FMCSA-
2015-0323; FMCSA-2016-0007; FMCSA-2018-0054]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to renew exemptions for nine
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: The exemptions were applicable on November 15, 2020. The
exemptions expire on November 15, 2022.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Dockets Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2013-0444, FMCSA-2014-0212, FMCSA-2015-
0320, FMCSA-2015-0323, FMCSA-2016-0007, or FMCSA-2018-0054, in the
keyword box, and click ``Search.'' Next, click the ``Open Docket
Folder'' button and choose the document to review. If you do not have
access to the internet, you may view the docket online by visiting
Dockets Operations in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between
9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.
To be sure someone is there to help you, please call<PHONE_NUMBER> or
(202) 366-9826 before visiting Dockets Operations.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    On October 28, 2020, FMCSA published a notice announcing its
decision to renew exemptions for nine individuals from the epilepsy and
seizure disorders prohibition in 49 CFR 391.41(b)(8) to operate a CMV
in interstate commerce and requested comments from the public (85 FR
68405). The public comment period ended on November 27, 2020, and no
comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that renewing these exemptions would achieve a level of
safety equivalent to, or greater than, the level that would be achieved
by complying with Sec.  391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in Sec.  391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.

    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce.
---------------------------------------------------------------------------

    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Conclusion

    Based on its evaluation of the nine renewal exemption applications,
FMCSA announces its decision to exempt the following drivers from the
epilepsy and seizure disorders prohibition in Sec.  391.41(b)(8).
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of November
and are discussed below.
    As of November 15, 2020, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following nine individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers (85 FR
68405):
Kevin Beamon (NY)
Joshua Cirilo (MN)
Peter DellaRocca, Jr. (PA)
Marvin Fender (CO)
Donald Horst (MD)
Chad T. Knott (MD)
Louis Lerch (IA)
Kyle Loney (WA)
Curtis J. Palubicki (MN)

    The drivers were included in docket number FMCSA-2013-0444, FMCSA-
2014-0212, FMCSA-2015-0320, FMCSA-2015-0323, FMCSA-2016-0007, and
FMCSA-2018-0054. Their exemptions were applicable as of November 15,
2020, and will expire on November 15, 2022.
    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315(b).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2020-27213 Filed 12-10-20; 8:45 am]
BILLING CODE 4910-EX-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

REGION III

1650 Arch Street

Philadelphia, Pennsylvania  19103

DATE:	July 19, 2011

SUBJECT:	Technical Support Document for Maryland’s Adoption of Plastic
Parts and Business Machines Coating Standards

			/s/

FROM:	Irene Shandruk, Physical Scientist

Office of Air Program Planning

TO:	File

			/s/

THRU: 	Cristina Fernandez, Associate Director

Office of Air Program Planning

A.  BACKGROUND

Section 172(c)(1) of the Clean Air Act (CAA) provides that state
implementation plans (SIPs) for nonattainment areas must include
reasonably available control measures (RACM), including reasonably
available control technology (RACT), for sources of emissions.  Section
182(b)(2)(A) provides that for certain nonattainment areas, States must
revise their SIPs to include RACT for sources of volatile organic
compound (VOC) emissions covered by a control techniques guidelines
(CTG) document issued after November 15, 1990 and prior to the area’s
date of attainment.

The United States Environmental Protection Agency (EPA) defines RACT as
“the lowest emission limitation that a particular source is capable of
meeting by the application of control technology that is reasonably
available considering technological and economic feasibility.” (44 FR
53761, Sept. 17, 1979).  In subsequent Federal Register notices, EPA has
addressed how states can meet the RACT requirements of the CAA.

CTGs are intended to provide state and local air pollution control
authorities information that should assist them in determining RACT for
VOCs from various sources, including miscellaneous metal product and
plastic parts surface coating operations.  In developing these CTGs,
EPA, among other things, evaluated the sources of VOC emissions from
this industry and the available control approaches for addressing these
emissions, including the costs of such approaches.  Based on available
information and data, EPA provides recommendations for RACT for VOCs
from miscellaneous metal product and plastic parts surface coating.

In June 1978, EPA published a CTG for controlling VOC emissions from
surface coating of miscellaneous metal and plastic products
(EPA-450/2-78-015).  This CTG discusses the nature of VOC emissions from
this industry, available control technologies for addressing such
emissions, the costs of available control options, and other items.  EPA
also published a national emission standard for hazardous air pollutants
(NESHAP) for surface coating of miscellaneous metal parts and products
surface coating (40 CFR part 63, subpart MMMM) and a NESHAP for plastic
parts and products surface coating in 2004 (40 CFR 63, subpart PPPP).

In 2008, after conducting a review of currently existing state and local
VOC emission reduction approaches for this industry, reviewing the 1978
CTG and the NESHAP for this industry, and taking into account the
information that has become available since then, EPA developed a new
CTG for surface coating of miscellaneous metal and plastic parts
products, entitled Control Techniques Guidelines for Miscellaneous Metal
and Plastic Parts Coatings (Publication No. EPA 453/R-08-003).

Description of Miscellaneous Metal and Plastic Parts Coatings

The miscellaneous metal product and plastic parts surface coatings
categories under section 183(e) of the CAA includes the coatings that
are applied to the surfaces of a varied range of metal and plastic parts
and products.  Such parts or products are constructed either entirely or
partially from metal or plastic.  The CTG applied to manufacturers of
miscellaneous metal and plastic parts that surface-coat the parts they
produce.  The CTG also applies to facilities that perform surface
coating of miscellaneous metal and plastic parts on a contract basis.

Miscellaneous metal product and plastic parts surface coatings serve
decorative, protective, and functional purposes.  Coatings protect metal
parts from corrosion by providing resistance to moisture, heat, and
sometimes the outdoor elements.  Plastic parts may be coated to provide
color, texture, or protection, thus improving appearance and durability,
and can also function to attenuate electromagnetic interference/radio
frequency interference signals, and to conceal mold lines and flaws in
substrate surface.

The miscellaneous metal product and plastic parts surface coating
process may be divided into three main unit operations:  (1) surface
preparation, (2) coating application operations, and (3) cleaning
activities.  These three types of activities utilize VOC-containing
compounds (i.e., coatings, thinners, and/or cleaning materials).  The
CTG provides control recommendations for reducing VOC emissions from the
use of these activities.

The VOC emissions from miscellaneous metal product and plastic parts
surface coating processes result from the evaporation of the volatile
components of the coatings and cleaning materials used in these
operations.  In most cases, VOC emissions from surface preparation,
storage, handling, and waste/wastewater operations are relatively small.

EPA’s Recommended Control Options for Miscellaneous Metal and Plastic
Parts Coatings

EPA issued a CTG for miscellaneous metal and plastic parts coatings in
September 2008 (Publication No. EPA 453/R-08-003).  EPA recommends that
the control approaches outlined below apply to each miscellaneous metal
product and plastic parts surface coating unit at a facility where the
total actual VOC emissions from all miscellaneous metal product and
plastic parts surface coating operations, including related cleaning
activities, at that facility are equal to or exceed 6.8 kilograms
(kg)/day (15 pounds (lbs)/day), or an equivalent level of 2.7 tons per
12-month rolling period, before consideration of controls.

The Control Techniques Guidelines for Miscellaneous Metal and Plastic
Parts Coatings document recommends emission limits for various metal and
plastic coatings and those emission limits that apply to this particular
State Implementation Plan (SIP) revision are as follow:

Table 1.  VOC Content Limits

Plastic Parts Coatings

Coating Category	kg VOC/liter coating	lbs VOC/gallon coating

General One Component	0.28	2.3

General Multi Component	0.42	3.5

Electric Dissipating Coatings and Shock-Free Coatings	0.80	6.7

Extreme Performance	0.42 (2-pack coatings)	3.5 (2-pack coatings)

Metallic	0.42	3.5

Military Specification	0.34 (1 pack)

0.42 (2 pack)	2.8 (1 pack)

3.5 (2 pack)

Mold-Seal	0.76	6.3

Multi-Colored Coatings	0.68	5.7

Optical Coatings	0.80	6.7

Vacuum-Metalizing	0.80	6.7

Business Machine Coatings

Primers	0.35	2.9

Topcoat	0.35	2.9

Texture Coat	0.35	2.9

Fog Coat	0.26	2.9

Touchup and repair	0.35	2.9

B.  STATE SUBMITTAL

On June 22, 2011, Maryland Department of the Environment (MDE) submitted
to EPA a SIP revision concerning the adoption of the emission limits for
plastic parts and business machines coatings, part of the EPA
miscellaneous metal and plastic parts coatings CTG.  EPA develops CTGs
as guidance on control requirements for source categories.  States can
follow the CTGs or adopt more restrictive standards.  The State of
Maryland has adopted EPA’s CTG standards for plastic parts and
business machine coating processes.  These regulations are in COMAR
26.11.19, Volatile Organic Compounds from Specific Processes.
Specifically, this revision amends the existing regulation at Section
<IP_ADDRESS> by moving existing VOC coating standards for plastic parts
and vinyl from Section <IP_ADDRESS> to new Section <IP_ADDRESS>-2, Plastic
Parts and Business Machines Coating.  Additionally, coating standards
for plastic parts and business machines from EPA’s CTG are being
adopted into COMAR <IP_ADDRESS>-2.  Work practice procedures for coating
can be found in COMAR <IP_ADDRESS>.  Specifically, requirements for
cleaning activities can be found in COMAR <IP_ADDRESS>(I) and these have
previously been approved into Maryland’s SIP.

The following changes are being made to COMAR 26.11.19:

The title of Section <IP_ADDRESS> is being changed from “Paper, Fabric,
Vinyl, and Other Plastic Parts” to “Paper, Fabric, Film, and Foil
Coating.”

Existing definitions in section <IP_ADDRESS>(A) and standards in Section
<IP_ADDRESS>(C)(3) pertaining to plastic parts and vinyl are being moved
to new Section <IP_ADDRESS>-2.

Section <IP_ADDRESS>-2, entitled Plastic Parts and Business Machines
Coatings, is added.  The following definitions are included in Section
<IP_ADDRESS>-2(A), Definitions: business machine, business machine
coating, electric dissipating coating, extreme performance coating, fog
coating, metallic coating, military specification coating, mold seal
coating, multi-colored coating, multi-component coating, one-component
coating, optical coating, plastic part, plastic part coating, prime
coat, shock-free coating, standard industrial classification code (SIC
code), texture coat, touch-up and repair coat, vacuum-metalizing
coatings, and vacuum metalizing process.

Section <IP_ADDRESS>-2(B), Standards for Coating Installations, includes
VOC emission limits for plastic parts coating standards, business
machines coating standards, and printing standards (see Tables 2-4).

Section <IP_ADDRESS>-2(C), Application Methods, lists the application
methods subject to this regulation.  They are:  electrostatic
application, high volume low pressure (HVLP) spray, flow coat, roller
coat, dip coat including electrodeposition, brush coat, or a coating
application method capable of achieving a transfer efficiency equivalent
to or better than the efficiency achieved by HVLP spraying.

Table 2.  Plastic Parts Coating Standards

Coating Installation	Applicability (lbs of VOC per day)	Pounds of VOC
Per Gallon of Coating (as applied minus water)	Kilograms of VOC Per
Liter of Coating (as applied minus water)

Decorative coating of other plastic parts	20	5.9	0.70

General, one-component	15	2.3	0.28

General, multi-component	15	3.5	0.42

Electric dissipating coatings and shock-free coatings	15	6.7	0.80

Extreme performance	15	3.5	0.42

Metallic	15	3.5	0.42

Military specification, one-component	15	2.8	0.34

Military specification, multi-component	15	3.5	0.42

Mold seal	15	6.3	0.76

Multi-colored coatings	15	5.7	0.68

Optical coatings	15	6.7	0.80

Plastic vehicle parts	20	3.0	0.36

Vacuum-metalizing	15	6.7	0.80

Vinyl	20	3.8	0.45

Table 3.  Business Machines Coating Standards

Coating Installation	Applicability (lbs of VOC per day)	Pounds of VOC
Per Gallon of Coating (as applied minus water)	Kilograms of VOC Per
Liter of Coating (as applied minus water)

Prime coat	15	2.9	0.35

Topcoat	15	2.9	0.35

Texture coat	15	2.9	0.35

Fog coat	15	2.9	0.26

Touchup and repair	15	2.9	0.35

Table 4.  Printing Standards

Printing  Installation	Applicability (lbs of VOC per day)	Pounds of VOC
Per Gallon of Coating (as applied minus water)	Kilograms of VOC Per
Liter of Coating (as applied minus water)

Plastic other than vinyl	Non-major source	5.8	0.69

Plastic other than vinyl	Major source as defined in COMAR
<IP_ADDRESS>B(4)	3.8	0.45

Vinyl	20	3.8	0.45

C.  EPA EVALUATION

MDE has adopted the standards and requirements of the CTG for a variety
of plastic parts coatings and business machine coating applications and
is amending the Maryland SIP to reflect these amendments.  The maximum
benefit from these amendments will be provided during the ozone season
when VOCs readily combine with nitrogen oxides (NOx) to form
ground-level ozone.  Specifically, emissions of VOCs from plastic parts
and products and business machines coating are expected to be reduced by
35 percent nationally from facilities above the recommended 6.8 kg/day
threshold as a result of this rulemaking, but because Maryland already
has regulations in place which have reduced VOC emissions from plastic
parts coating, the reduction is expected to be less than that on a
national level.  Nonetheless, this revision will help Maryland attain
and maintain the National Ambient Air Quality Standards (NAAQS) for
ozone.

D.  CONCLUSIONS AND RECOMMENDED AGENCY ACTION

The adoption of the EPA CTG requirements for plastic parts coatings and
business machines coating standards by the State of Maryland will result
in the reduction of VOC emissions from plastic parts and business
machines coatings.  EPA’s approval of the SIP revision is recommended.

 PAGE

 PAGE   1


[Federal Register Volume 81, Number 136 (Friday, July 15, 2016)]
[Notices]
[Pages 46140-46143]
[FR Doc No: 2016-16718]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78277; File No. SR-OCC-2016-007]

Self-Regulatory Organizations; The Options Clearing Corporation;
Order Approving Proposed Rule Change Related to The Options Clearing
Corporation's Membership Approval Process

July 11, 2016.
    On May 16, 2016, The Options Clearing Corporation (``OCC'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change SR-OCC-2016-007 pursuant to Section 19(b)(1) of
the Securities and Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder.\2\ The Commission did not receive any comments on the
proposed rule change. This order approves the proposed rule change.
---------------------------------------------------------------------------

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

I. Description

    OCC is changing its rules to: (i) Vest the authority to approve or
disapprove

new membership applications with OCC's Risk Committee,\3\ and (ii)
delegate authority to the Executive Chairman or President of OCC to
approve new membership applications provided that: (a) It is not
recommended that the Risk Committee impose additional membership
criteria upon the applicant pursuant to Section 1, Interpretation and
Policy .06 of Article V of OCC's By-Laws, and (b) the Risk Committee is
given not less than five business days to determine that the
application should be reviewed at a meeting of the Risk Committee and
the Risk Committee has not requested that the application be reviewed
at a meeting of the Risk Committee within such five day period.
---------------------------------------------------------------------------

    \3\ OCC's Risk Committee is a committee of OCC's Board of
Directors. See OCC's By-Laws Article III, Section 9.
---------------------------------------------------------------------------

    This proposed rule change will streamline OCC's membership approval
process by: (i) Allowing OCC's Executive Chairman or President to
approve pro forma applications for clearing membership, and (ii)
vesting ultimate authority with OCC's Risk Committee, not its Board, to
approve or disapprove applications for clearing membership that are not
approved by either OCC's Executive Chairman or President. The practical
effect of the proposed rule change is that either OCC's Executive
Chairman or President will approve most applications for clearing
membership at OCC since most applicants for clearing membership choose
to have their application presented for approval only when such
approval is pro forma in nature (i.e., the applicant meets all of the
clearing membership requirements at OCC and there is no need to impose
additional membership requirements). OCC believes that the proposed
rule change will better allocate the time and resources of the Board
and Risk Committee and ensure applications for clearing membership are
considered in a timely manner.

Background

    OCC believes that its membership criteria are objective standards
that are designed not to unfairly discriminate in the admission of
participants to OCC,\4\ as well as to provide for fair and open access
to OCC.\5\ Currently, the authority to approve or disapprove new
applications for clearing membership resides with the Board.\6\ Under
Article V, Section 2 of OCC's By-Laws, OCC's Risk Committee, including
its designated delegates or agents, is responsible for reviewing
applications for clearing membership, and the Risk Committee is
responsible for making a recommendation of approval or disapproval to
the Board (in part, relying on OCC's Management's review and
recommendation).\7\ OCC's management (``Management'') performs the
substantive review of applications for clearing membership on behalf of
the Risk Committee. Management reviews a given application against
OCC's membership criteria, which are set forth in Article V of OCC's
By-Laws as well as Chapters 2 and 3 of OCC's Rules. Based on its
review, Management, as the subject matter expert on OCC's membership
criteria, either recommends an application for approval without
conditions, recommends an application for approval with conditions (in
accordance with OCC's By-Laws, Article V, Section 1, Interpretation and
Policy .06), or does not recommend an application for approval. The
Risk Committee, based on Management's review of the application,
recommends a course of action to OCC's Board. OCC's Board then approves
or disapproves applications for clearing membership based on the Risk
Committee's recommendation.
---------------------------------------------------------------------------

    \4\ See 15 U.S.C. 78q-1(b)(3)(F).
    \5\ See 7 U.S.C. 7a-1(c)(2)(C)(iii)(III).
    \6\ See OCC's By-Laws Article V, Section 2.
    \7\ See OCC's By-Laws Article V, Section 2. The Risk Committee,
from a practical perspective, has designated OCC's management as its
agent to review applications for clearing membership. OCC's
management reviews applications for clearing membership and makes a
recommendation to the Risk Committee concerning the applicant's
satisfaction of OCC's membership criteria.
---------------------------------------------------------------------------

    Moreover, since the rules of the Commission and the Commodity
Futures Trading Commission require OCC to have rules that do not
unfairly discriminate in the admission of participants and provide fair
and open access,\8\ OCC believes that, under its rules, it is required
to admit applicants for clearing membership that clearly meet OCC's
membership criteria, and therefore, that the Board's ultimate approval
of an application for clearing membership for which Management does not
recommend approval with conditions or disapproval is pro forma. From a
timing perspective, applications for clearing membership often do not
track the Risk Committee or Board's regular meeting schedule and, on
occasion, the Board has had to convene a special meeting for the sole
purpose of considering an application for clearing membership or
otherwise has had to seek approval via unanimous written consent, which
OCC believes is an inefficient use of the Board's time and resources.
In an effort to better allocate the time and resources of OCC's Board
and Risk Committee as well as streamline its clearing membership
approval process, OCC proposed the amendments to Articles V and VIII of
its By-Laws as well as the Board and Risk Committee Charters described
below. The effect of such amendments is that either OCC's Executive
Chairman or President will approve most applications for clearing
membership, thereby allowing the Board and the Risk Committee to better
allocate their time and resources.
---------------------------------------------------------------------------

    \8\ See 15 U.S.C. 78q-1(b)(3)(F) and 7 U.S.C. 7a-1(c)(2)(C).
---------------------------------------------------------------------------

Changes to Vest Authority of New Applicant Approvals With the Risk
Committee

    OCC proposed amending Article V, Section 2 of its By-Laws to vest
the authority to approve or disapprove new applicants for clearing
membership with the Risk Committee. OCC believes that the members of
the Board comprising the Risk Committee are capable of appropriately
acting on membership applications. The Risk Committee is currently
delegated the authority to (1) review applications for clearing
membership and recommend approval or disapproval thereof to the Board,
(2) conduct hearings if requested by applicants whose applications are
proposed to be disapproved, and (3) review and approve or disapprove
requests by clearing members to expand clearing activities.\9\
Therefore, OCC believes that requiring the Board to approve or
disapprove an application for clearing membership that has already been
reviewed by, and received a recommendation for approval or disapproval
from, the Risk Committee is redundant and represents an inefficient use
of the Board's time. Accordingly, OCC believes that the Risk Committee
is the appropriate governing body in which to vest ultimate authority
to approve or disapprove applications for clearing membership.\10\
Should the Risk Committee propose to disapprove an application for
clearing membership, the Risk Committee must first provide the
applicant an opportunity to be heard and present evidence on its own
behalf (as is currently the case today with respect to the Board's
decision to

disapprove an application for clearing membership).\11\
---------------------------------------------------------------------------

    \9\ See Section IV of the Risk Committee Charter provided as
Exhibit 5B to the proposed rule change.
    \10\ The Board will continue to oversee OCC's membership
criteria and ongoing membership standards through its authority to
approve changes to OCC's By-Laws and Rules (and specifically those
By-Laws and Rules that concern membership). The Risk Committee will
inform the Board, at the Board's next regularly scheduled meeting,
of applications for clearing membership pursuant to proposed Article
V, Section 2(c) of the By-Laws.
    \11\ See OCC's By-Laws Article V, Section 2. Typically, however,
if OCC's due diligence review reveals issues that would prevent the
Board or the Risk Committee from approving an application for
clearing membership, the applicant voluntarily remediates such
issues prior to the presentation of the application for clearing
membership to the Risk Committee.
---------------------------------------------------------------------------

    In order to effect the foregoing, and in addition to proposed
changes to Article V, Section 2 of the By-Laws, OCC proposed conforming
changes to Article V, Sections 1 and 3 of the By-Laws as well as the
Board and Risk Committee Charters.\12\ Such conforming changes identify
that the Risk Committee, and not the Board, will approve applications
for clearing membership. Additionally, OCC proposed changes to Article
VIII, Section 2 of the By-Laws (as well as the Board and Risk Committee
Charters) to identify that the Risk Committee, and not the Board, will
set initial clearing fund requirements in connection with the approval
of an application for clearing membership.
---------------------------------------------------------------------------

    \12\ Marked versions of the Board and Risk Committee Charters
were provided as Exhibits 5A and 5B to the proposed change.
---------------------------------------------------------------------------

Delegation of Authority To Approve Applications for Membership to the
Executive Chairman or President of OCC

    OCC has stated that, in order to better streamline OCC's membership
application approval process, and allow the Board and the Risk
Committee to more efficiently allocate their time, it proposed
additional amendments to Article V, Section 2 of its By-Laws to allow
OCC's Executive Chairman or its President to approve certain
applications for clearing membership. As described above: (i) OCC
believes that, based on the applicable rules of the Commission and the
Commodity Futures Trading Commission, applications for clearing
membership that clearly meet OCC's membership criteria must be
approved,\13\ and (ii) applications for clearing members do not
necessarily track the Risk Committee or Board's regular meeting
schedule and, on occasion, the Board has had to convene in a special
meeting for the sole purpose of considering a clearing member
application or otherwise seek approval via unanimous written consent,
which is not a good use of either the Board or the Risk Committee's
time and resources. Therefore, OCC proposed amending Article V, Section
2 of its By-Laws to delegate the authority to approve applications for
clearing membership to the Executive Chairman or President of OCC
provided that: (i) It is not recommended that the Risk Committee impose
additional membership criteria upon the applicant pursuant to Section
1, Interpretation and Policy .06 of Article V of OCC's By-Laws, and
(ii) the Risk Committee is given not less than five business days from
the date it is notified by its designated delegates or agents that the
Executive Chairman or President intends to approve a given application
to determine that such application should be reviewed at a meeting of
the Risk Committee and the Risk Committee has not requested that the
application be reviewed at a meeting of the Risk Committee within such
five day period. If five business days pass and no member of the Risk
Committee notifies Management that a given application for clearing
membership should be reviewed at a meeting of the Risk Committee, then
the Executive Chairman and President shall have the authority to
approve the application for clearing membership. This proposed change
will allow either OCC's Executive Chairman or the President to approve
most applications for clearing membership received by OCC. Neither the
Executive Chairman nor the President will be allowed to disapprove an
application for clearing membership. Instead, if either the Executive
Chairman or President determined he cannot approve an application for
clearing membership, the application will be considered by the Risk
Committee for approval or disapproval at its next regularly scheduled
meeting. OCC believes that allowing the Executive Chairman or President
to approve applications for clearing membership that clearly meet OCC's
membership criteria will allow the Board and the Risk Committee to
allocate their time to more efficiently and effectively.
---------------------------------------------------------------------------

    \13\ See 15 U.S.C. 78q-1(b)(3)(F) and 7 U.S.C. 7a-1(c)(2)(C).
---------------------------------------------------------------------------

II. Discussion

    Section 19(b)(2)(C) of the Act \14\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if it
finds that the rule change, as proposed, is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to such organization.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(2)(C).
---------------------------------------------------------------------------

    The Commission finds that the proposed rule change is consistent
with Section 17A(b)(3)(F) \15\ of the Act. This section requires, among
other things, that the rules of a clearing agency be designed to
protect investors and the public interest while not being designed to
permit unfair discrimination in the admission of participants. The
proposed rule change will preserve Board-level oversight for the
membership approval process by vesting the authority to approve or
disapprove applications for clearing membership with the Risk
Committee, a Board-level committee. A considerable portion of the Risk
Committee's functions and responsibilities, as listed in its charter,
pertains to the oversight of membership and membership standards
generally. Therefore it is reasonable to expect that the Risk Committee
should have the requisite expertise and authority to carry out the
membership application approval or disapproval process previously
tasked to the entire Board.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    The proposed rules also delegate to the Executive Chairman or the
President the authority to approve new applications provided that: (i)
It is not recommended that the Risk Committee impose additional
membership criteria upon the applicant pursuant to Section 1,
Interpretation and Policy .06 of Article V of OCC's By-Laws, and (ii)
the Risk Committee is given not less than five business days to
determine that the application should be reviewed at a meeting of the
Risk Committee and the Risk Committee has not requested that the
application be reviewed at a meeting of the Risk Committee within such
five day period. The authority to disapprove applications is not
delegated to the Executive Chairman or the President. The rules, as
revised, continue to provide Board-level oversight of the membership
approval process by ensuring involvement of the Risk Committee. For the
above reasons, although the revised rules will streamline the
membership approval process, the Commission believes that they are
designed to protect investors and the public interest. Additionally,
the revised rules are not designed to permit unfair discrimination
because they do not alter the criteria considered for the approval of
new membership.
    Additionally, the Commission finds that the revised rules are
consistent with Rule 17Ad-22(d)(8) under the Act.\16\ Rule 17Ad-
22(d)(8) requires that a clearing agency establish, implement,
maintain, and enforce written policies and procedures reasonably
designed to, as applicable, have governance arrangements that are clear
and transparent to fulfill the public interest requirements in Section
17A of the Act \17\ applicable to clearing agencies and support the
objectives of owners and participants. OCC's revised rules

provide clarity and transparency in its governance processes by
identifying, in OCC's public rulebook, the parties authorized to
approve or disapprove membership applications, and fulfill the public
interest requirements of Section 17A of the Act as described above.
---------------------------------------------------------------------------

    \16\ 17 CFR 240.17Ad-22(d)(8).
    \17\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

III. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of Act, and in particular,
with the requirements of Section 17A of the Act \18\ and the rules and
regulations thereunder.
---------------------------------------------------------------------------

    \18\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    IT IS THEREFORE ORDERED, pursuant to Section 19(b)(2) of the
Act,\19\ that the proposed rule change (SR-OCC-2016-007) be, and it
hereby is, approved.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-16718 Filed 7-14-16; 8:45 am]
 BILLING CODE 8011-01-P