[Federal Register Volume 86, Number 55 (Wednesday, March 24, 2021)]
[Notices]
[Pages 15686-15691]
[FR Doc No: 2021-06052]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-M-3841, FDA-2018-M-3842, FDA-2018-M-3983, FDA-
2018-M-4033, FDA-2018-M-4205, FDA-2018-M-4580, FDA-2018-M-4582, FDA-
2018-M-4665, FDA-2018-M-4777, FDA-2018-M-4778, FDA-2018-M-4779, FDA-
2018-M-4780, FDA-2018-M-4916, FDA-2019-M-0027, FDA-2019-M-0028, FDA-
2019-M-0505, FDA-2019-M-0645, FDA-2019-M-0802, FDA-2019-M-0885, FDA-
2019-M-0995, FDA-2019-M-1214, FDA-2019-M-1251, FDA-2019-M-1310, FDA-
2019-M-1313, FDA-2019-M-1465, FDA-2019-M-1506, FDA-2019-M-1582, FDA-
2019-M-1763, FDA-2019-M-1848, FDA-2019-M-1979, FDA-2019-M-1998, FDA-
2019-M-2052, FDA-2019-M-2193, FDA-2019-M-2408, FDA-M-2522, FDA-2019-M-
2560, FDA-2019-M-2561, FDA-2019-M-2671, FDA-2019-M-2732, FDA-2019-M-
2753, FDA-2019-M-2782, FDA-2019-M-3309, FDA-2019-M-3513, FDA-2019-M-
3652, FDA-2019-M-3845, FDA-2019-M-3863, FDA-2019-M-3844, FDA-2019-M-
4007, FDA-2019-M-4153, FDA-2019-M-4186, FDA-2019-M-4238, FDA-2019-M-
4928, FDA-2019-M-4978, FDA-2019-M-5393, FDA-2019-M-5438, FDA-2019-M-
5534, FDA-2019-M-5605, FDA-2019-M-5683, FDA-2019-M-5741, FDA-2019-M-
5857, FDA-2019-M-5961, FDA-2020-M-0097, FDA-2020-M-0107, FDA-2020-M-
0108, FDA-2020-M-0495, FDA-2020-M-0985, FDA-2020-M-0984, FDA-2020-M-
0986, FDA-2020-M-1083, FDA-2020-M-1115, FDA-2020-M-1116, FDA-2020-M-
1175, FDA-2020-M-1213, FDA-2020-M-1214, FDA-2020-M-1267, FDA-2020-M-
1286, FDA-2020-M-1290, FDA-2020-M-1299, FDA-2020-M-1300, FDA-2020-M-
1311, FDA-2020-M-1358, FDA-2020-M-1367, FDA-2020-M-1410, FDA-2020-M-
1420, FDA-2020-M-1527, FDA-2020-M-1583, FDA-2020-M-1600, FDA-2020-M-
1612, FDA-2020-M-1613, FDA-2020-M-1715, FDA-2020-M-1724, FDA-2020-M-
1726, FDA-2020-M-1748, FDA-2020-M-1752, FDA-2020-M-1760, FDA-2020-M-
1821, FDA-2020-M-1783, FDA-2020-M-1822, FDA-2020-M-1828, FDA-2020-M-
1830, FDA-2020-M-1829, FDA-2020-M-1835, FDA-2020-M-1838, FDA-2020-M-
1868, FDA-2020-M-1986, FDA-2020-M-2021, FDA-2020-M-2288, FDA-2020-M-
2248, and FDA-2020-M-2339]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing
a list of premarket approval applications (PMAs) that have been
approved from October 1, 2018, through December 31, 2020. 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-2018-M-3841, FDA-2018-M-3842, FDA-2018-M-3983, FDA-2018-M-4033,
FDA-2018-M-4205, FDA-2018-M-4580, FDA-2018-M-4582, FDA-

2018-M-4665, FDA-2018-M-4777, FDA-2018-M-4778, FDA-2018-M-4779, FDA-
2018-M-4780, FDA-2018-M-4916, FDA-2019-M-0027, FDA-2019-M-0028, FDA-
2019-M-0505, FDA-2019-M-0645, FDA-2019-M-0802, FDA-2019-M-0885, FDA-
2019-M-0995, FDA-2019-M-1214, FDA-2019-M-1251, FDA-2019-M-1310, FDA-
2019-M-1313, FDA-2019-M-1465, FDA-2019-M-1506, FDA-2019-M-1582, FDA-
2019-M-1763, FDA-2019-M-1848, FDA-2019-M-1979, FDA-2019-M-1998, FDA-
2019-M-2052, FDA-2019-M-2193, FDA-2019-M-2408, FDA-2019-M-2522, FDA-
2019-M-2560, FDA-2019-M-2561, FDA-2019-M-2671, FDA-2019-M-2732, FDA-
2019-M-2753, FDA-2019-M-2782, FDA-2019-M-3309, FDA-2019-M-3513, FDA-
2019-M-3652, FDA-M-3845, FDA-2019-M-3862, FDA-2019-M-3863, FDA-2019-M-
3844, FDA-2019-M-4007, FDA-2019-M-4153, FDA-2019-M-4186, FDA-2019-M-
4238, FDA-2019-M-4928, FDA-2019-M-4978, FDA-2019-M-5393, FDA-2019-M-
5438, FDA-2019-M-5534, FDA-2019-M-5605, FDA-2019-M-5683, FDA-2019-M-
5741, FDA-2019-M-5857, FDA-2019-M-5961, FDA-2020-M-0097, FDA-2020-M-
0107, FDA-2020-M-0108, FDA-2020-M-0495, FDA-2020-M-0985, FDA-2020-M-
0984, FDA-2020-M-0986, FDA-2020-M-1083, FDA-2020-M-1115, FDA-2020-M-
1116, FDA-2020-M-1175, FDA-2020-M-1213, FDA-2020-M-1214, FDA-2020-M-
1267, FDA-2020-M-1286, FDA-2020-M-1290, FDA-2020-M-1299, FDA-2020-M-
1300, FDA-2020-M-1311, FDA-2020-M-1358, FDA-2020-M-1367, FDA-2020-M-
1410, FDA-2020-M-1420, FDA-2020-M-1527, FDA-2020-M-1583, FDA-2020-M-
1600, FDA-2020-M-1612, FDA-2020-M-1613, FDA-2020-M-1715, FDA-2020-M-
1724, FDA-2020-M-1726, FDA-2020-M-1748, FDA-2020-M-1752, FDA-2020-M-
1760, FDA-2020-M-1821, FDA-2020-M-1783, FDA-2020-M-1822, FDA-2020-M-
1828, FDA-2020-M-1830, FDA-2020-M-1829, FDA-2020-M-1835, FDA-2020-M-
1838, FDA-2020-M-1868, FDA-2020-M-1986, FDA-2020-M-2021, FDA-2020-M-
2288, FDA-2020-M-2248, and FDA-2020-M-2339 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, 240-
402-7500.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Dharmesh Patel, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2434, 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 (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 published in the Federal Register.
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 list of available safety
and effectiveness summaries of PMA approvals and denials that were
announced. The following is a list of approved PMAs for which summaries
of safety and effectiveness were placed on the internet from October 1,
2018, through December 31, 2020. 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 and Safety and Probable Benefit Summaries
                for Approved HDEs Made Available From October 1, 2018, Through December 31, 2020
----------------------------------------------------------------------------------------------------------------
          PMA No., Docket No.                   Applicant                   Trade name            Approval date
----------------------------------------------------------------------------------------------------------------
P180003, FDA-2018-M-3841..............  Veryan Medical Ltd......  BioMimics 3D Vascular Stent          10/4/2018
                                                                   System.
P150040/S003, FDA-2018-M-3842.........  Carl Zeiss Meditec, Inc.  VisuMax Femtosecond Laser....        10/4/2018
P160054/S008, FDA-2018-M-3983.........  Thoratec Corp...........  HeartMate 3 Left Ventricular        10/18/2018
                                                                   Assist System.
P100040/S036, FDA-2018-M-4033.........  Medtronic Vascular......  Valiant NavionTM Thoracic           10/19/2018
                                                                   Stent Graft System.
P180010, FDA-2018-M-4205..............  W.L. Gore & Associates,   GORE Carotid Stent...........        11/1/2018
                                         Inc.
P150002, FDA-2018-M-4580..............  Cordis Corp.............  Cordis INCRAFT[supreg] AAA          11/27/2018
                                                                   Stent Graft System.

P120016/S024, FDA-2018-M-4582.........  Cardiva Medical, Inc....  VASCADE[supreg] MVP Venous          11/27/2018
                                                                   Vascular Closure System.
P180007, FDA-2018-M-4665..............  Spiration, Inc..........  Spiration[supreg] Valve              12/3/2018
                                                                   System.
P160034, FDA-2018-M-4672..............  Cardiac Science Corp....  Powerheart[supreg] G3 Pro AED        12/6/2018
P160033, FDA-2018-M-4675..............  Cardiac Science Corp....  Powerheart[supreg] G5 AED,           12/7/2018
                                                                   Powerheart[supreg] AED G3
                                                                   Plus, And Powerheart[supreg]
                                                                   AED G3.
P160043/S012, FDA-2018-M-4777.........  Medtronic Vascular......  Resolute OnyxTM Zotarolimus-        12/14/2018
                                                                   Eluting Coronary Stent
                                                                   System.
P110013/S088, FDA-2018-M-4778.........  Medtronic Vascular......  Resolute Integrity                  12/14/2018
                                                                   Zotarolimus-Eluting Coronary
                                                                   Stent System.
P100018/S015, FDA-2018-M-4779.........  Micro Therapeutics, Inc.  PipelineTM Flex Embolization        12/14/2018
                                         d/b/a ev3 Neurovascular.  Device.
P150038/S006, FDA-2018-M-4780.........  InSightec, Inc..........  Exablate Model 4000 Types 1.0       12/16/2018
                                                                   and 1.1 System (Exablate
                                                                   Neuro).
P170018, FDA-2018-M-4916..............  Physio-Control, Inc.....  LIFEPAK[supreg] CR2                 12/21/2018
                                                                   Defibrillator.
P170032, FDA-2019-M-0027..............  Sequent Medical, Inc....  Woven EndoBridge (WEB)              12/31/2018
                                                                   Aneurysm Embolization System.
P180001, FDA-2019-M-0028..............  William Cook Europe ApS.  Zenith[supreg] Dissection           12/31/2018
                                                                   Endovascular System.
P170037, FDA-2019-M-0505..............  OPKO Diagnostics, LLC...  Sangia Total PSA Test........        1/30/2019
P180025, FDA-19M-2526.................  Essential Medical, Inc..  MANTATM Vascular Closure              2/1/2019
                                                                   Device.
P170036, FDA-2019-M-0645..............  Spinal Kinetics LLC.....  M6-CTM Artificial Cervical            2/6/2019
                                                                   Disc.
P160050, FDA-2019-M-0802..............  Intrinsic Therapeutics..  Barricaid[supreg] Anular              2/8/2019
                                                                   Closure Device (ACD).
P170030, FDA-2019-M-0885..............  Biotronik, Inc..........  Orsiro Sirolimus Eluting             2/22/2019
                                                                   Coronary Stent System
                                                                   (Orsiro Stent System).
P170042/S002, FDA-2019-M-0995.........  C.R. Bard, Inc..........  COVERATM Vascular Covered             3/1/2019
                                                                   Stent.
P160002/S009, FDA-2019-M-1310.........  Ventana Medical System,   VENTANA PD-L1 (SP142) Assay..         3/8/2019
                                         Inc.
P180037, FDA-2019-M-1214..............  Bard Peripheral           VENOVO Venous Stent System...        3/13/2019
                                         Vascular, Inc. (BPV).
P100009/S028, FDA-2019-M-1251.........  Abbott Vascular, Inc....  MitraClip NT Clip Delivery           3/14/2019
                                                                   System; MitraClip NTR/XTR
                                                                   Clip Delivery System.
P180036, FDA-2019-M-1313..............  Impulse Dynamics (USA),   OPTIMIZER Smart System.......        3/21/2019
                                         Inc.
P180040, FDA-2019-M-1465..............  Fidia Pharma USA, Inc...  TRILURONTM...................        3/26/2019
P180032, FDA-2019-M-1506..............  Channel Medsystems, Inc.  Cerene[supreg] Cryotherapy           3/28/2019
                                                                   Device.
P170027, FDA-2019-M-1582..............  TherOx, Inc.............  TherOx DownStream System.....         4/2/2019
P180034, FDA-2019-M-1763..............  Intact Vascular, Inc....  Tack Endovascular                    4/11/2019
                                                                   System[supreg] (6F).
P180043, FDA-2019-M-1979..............  QIAGEN Manchester Ltd...  therascreen[supreg] FGFR RGQ         4/12/2019
                                                                   RT-PCR Kit.
P180024, FDA-2019-M-1848..............  BAROnova, Inc...........  TransPyloric Shuttle/                4/16/2019
                                                                   TransPyloric Shuttle
                                                                   Delivery Device.
P180029, FDA-2019-M-1998..............  Boston Scientific Corp..  LOTUS EdgeTM Valve System....        4/23/2019
P180014, FDA-2019-M-2052..............  XVIVO Perfusion, Inc....  XVIVO Perfusion System               4/26/2019
                                                                   (XPSTM) with STEEN
                                                                   SolutionTM Perfusate.
P180013, FDA-2019-M-2193..............  Boston Scientific Corp..  VICI VENOUS STENT[supreg]             5/2/2019
                                                                   System.
P180031, FDA-2019-M-2408..............  Stryker Neurovascular...  Neuroform Atlas[supreg] Stent        5/16/2019
                                                                   System.
H180002, FDA-2019-M-2522..............  Novocure, Ltd...........  NovoTTFTM-100L System........        5/23/2019
P190001, FDA-2019-M-2560..............  QIAGEN GmbH.............  therascreen PIK3CA RGQ PCR           5/24/2019
                                                                   Kit.
P190004, FDA-2019-M-2561..............  QIAGEN GmbH.............  therascreen PIK3CA RGQ PCR           5/24/2019
                                                                   Kit.
P160013/S002, FDA-2019-M-2671.........  TransMedics, Inc........  Organ Care System (OCSTM)            5/31/2019
                                                                   Lung System.
P160036, FDA-2019-M-2732..............  DT MedTech, LLC.........  Hintermann Series H3TM Total          6/4/2019
                                                                   Ankle Replacement System.
P160048/S006, FDA-2019-M-2753.........  Senseonics, Inc.........  Eversense Continuous Glucose          6/6/2019
                                                                   Monitoring System.
P160029, FDA-2019-M-2782..............  Philips Medical Systems,  HeartStart OnSite                     6/6/2019
                                         Inc.                      Defibrillator (Model
                                                                   M5066A), HeartStart Home
                                                                   Defibrillator (Model
                                                                   M5068A), Primary Battery
                                                                   (Model M5070A), SMART Pads
                                                                   Cartridges (Adult Model
                                                                   M5071A) and Infant/Child
                                                                   (Model M5072A).
P150013/S014, FDA-2019-M-3309.........  Dako North America, Inc.  PD-L1 IHC 22C3 pharmDx.......        6/10/2019
P000025/S104, FDA-2019-M-3513.........  MED-EL Corp.............  MED-EL Cochlear Implant              7/19/2019
                                                                   System.
P150013/S016, FDA-2019-M-3652.........  Dako North America, Inc.  PD-L1 1HC 22C3 pharmDx.......        7/30/2019
P140031/S085, FDA-2019-M-3845.........  Edwards Lifesciences LLC  Edwards SAPIEN 3                     8/16/2019
                                                                   Transcatheter Heart Valve
                                                                   System and Edwards SAPIEN 3
                                                                   Ultra Transcatheter Heart
                                                                   Valve System.
H190005, FDA-2019-M-3863..............  Zimmer Biomet Spine, Inc  The TetherTM--Vertebral Body         8/16/2019
                                                                   Tethering System.
P180050, FDA-2019-M-3862..............  CVRx, Inc...............  BAROSTIM NEO[supreg] System..        8/16/2019
P130021/S058, FDA-2019-M-3844.........  Medtronic CoreValve LLC.  Medtronic CoreValve Evolut R         8/16/2019
                                                                   System and Medtronic
                                                                   CoreValve Evolut PRO System.
H170001, FDA-2019-M-4007..............  ApiFix, Ltd.............  Minimally Invasive Deformity           8/23/19
                                                                   Correction (MID-C) System.

P040020/S087, FDA-2019-M-4153.........  Alcon Laboratories, Inc.  AcrySof[supreg] IQ                   8/26/2019
                                                                   PanOptix[supreg] Trifocal
                                                                   Intraocular Lens (Model
                                                                   TFNT00) and AcrySof[supreg]
                                                                   IQ PanOptix[supreg] Toric
                                                                   Trifocal Intraocular Lens
                                                                   (Models TFNT30, TFNT40,
                                                                   TFNT50 and TFNT60).
P190006, FDA-2019-M-4186..............  Axonics Modulation        Axonics Sacral                        9/6/2019
                                         Technologies, Inc.        Neuromodulation System.
P930016/S057, FDA-2019-M-4238.........  AMO Manufacturing USA,    iDESIGN[supreg] Refractive            9/9/2019
                                         LLC.                      Studio and STAR S4
                                                                   IR[supreg] Excimer Laser
                                                                   Systems.
P190011, FDA-2019-M-4928..............  DiaSorin Inc............  LIAISON XL MUREX HCV Ab             10/18/2019
                                                                   LIAISON XL MUREX Control HCV
                                                                   Ab.
P190014, FDA-2019-M-4978..............  Myriad Genetic            Myriad myChoice[supreg] CDx..       10/23/2019
                                         Laboratories, Inc.
P180046, FDA-2019-M-5393..............  Axonics Modulation        Axonics Sacral                      11/13/2019
                                         Technologies, Inc.        Neuromodulation System.
P180035, FDA-2019-M-5438..............  CooperVision, Inc.......  MiSight 1 Day (omafilcon A)         11/15/2019
                                                                   Soft (Hydrophilic) Contact
                                                                   Lenses for Daily Wear.
P190008, FDA-2019-M-5534..............  Medtronic, Inc..........  IN.PACTTM AV Paclitaxel-            11/21/2019
                                                                   coated Percutaneous
                                                                   Transluminal Angioplasty
                                                                   (PTA) Balloon Catheter.
P190016, FDA-2019-M-5605..............  Tusker Medical, Inc.....  Tula[supreg] System..........       11/25/2019
P180047, FDA-2019-M-5683..............  DiaSorin, Inc...........  LIAISON QuantiFERON--TB Gold        11/26/2019
                                                                   Plus, LIAISON Control
                                                                   QuantiFERON--TB Gold Plus
                                                                   and LIAISON QuantiFERON
                                                                   Software.
P170019/S006, FDA-2019-M-5741.........  Foundation Medicine, Inc  FoundationOne[supreg] CDx....        12/3/2019
P170038, FDA-2019-M-5857..............  Abbott..................  CentriMag Circulatory Support        12/6/2019
                                                                   System.
P180027, FDA-2019-M-5961..............  MicroVention, Inc.......  Flow Re-Direction Endoluminal       12/16/2019
                                                                   Device (FRED[supreg]) System.
P140009/S039, FDA-2020-M-0097.........  Abbott Medical, Inc.....  Abbott InfinityTM DBS System.         1/2/2020
P180038, FDA-2020-M-0107..............  DiaSorin, Inc...........  LIAISON[supreg] XL MUREX Anti-        1/2/2020
                                                                   HBc, LIAISON[supreg] XL
                                                                   MUREX Control Anti-HBc.
P190018, FDA-2020-M-0108..............  Alcon Research, Inc.....  ClareonTM Aspheric                    1/7/2020
                                                                   Hydrophobic Acrylic
                                                                   Intraocular Lens (IOL)
                                                                   (Model Number: SY60WF);
                                                                   ClareonTM Toric Aspheric
                                                                   Hydrophobic Acrylic
                                                                   Intraocular Lens (IOL)
                                                                   (Model Numbers: CNW0T3,
                                                                   CNW0T4, CNW0T5, CNW0T6,
                                                                   CNW0T7, CNW0T8 and CNW0T9);
                                                                   ClareonTM Aspheric
                                                                   Hydrophobic Acrylic
                                                                   Intraocular Lens (IOL) with
                                                                   the AutonoMeTM Pre-loaded
                                                                   Delivery System (Model
                                                                   Number: CNA0T0); ClareonTM
                                                                   Toric Aspheric Hydrophobic
                                                                   Acrylic Intraocular Lens
                                                                   (IOL) with the AutonoMeTM
                                                                   Pre-loaded Delivery System
                                                                   (Model Numbers: CNA0T3,
                                                                   CNA0T4, CNA0T5, CNA0T6,
                                                                   CNA0T7, CNA0T8 and CNA0T9).
P170023, FDA-2020-M-0495..............  Contura International A/  Bulkamid[supreg] Urethral            1/28/2020
                                         S.                        Bulking System.
P170022, FDA-2020-M-0985..............  ARJ Medical, Inc........  PyloPlus UBT System..........        2/18/2020
P180039, FDA-2020-M-0984..............  DiaSorin Inc............  LIAISON[supreg] XL MUREX Anti-       2/21/2020
                                                                   HBs; LIAISON[supreg] XL
                                                                   MUREX Control Anti-HBs;
                                                                   LIAISON[supreg] XL MUREX
                                                                   Anti-HBs Verifiers.
P930014/S126, FDA-2020-M-0986.........  Alcon Laboratories, Inc.  AcrySofTM IQ VivityTM                2/26/2020
                                                                   Extended Vision Intraocular
                                                                   Lens (Model DFT015);
                                                                   AcrySofTM IQ VivityTM Toric
                                                                   Extended Vision IOLs
                                                                   (DFT315, DFT 415, DFT515);
                                                                   AcrySofTM IQ VivityTM
                                                                   Extended Vision UV Absorbing
                                                                   IOL (DAT015); AcrySofTM IQ
                                                                   VivityTM Toric Extended
                                                                   Vision UV Absorbing IOLs
                                                                   (DAT315, DAT415, DAT515).
P190024, FDA-2020-M-1083..............  Ventana Medical Systems,  CINtec[supreg] PLUS Cytology.        3/10/2020
                                         Inc.
P120006/S031, FDA-2020-M-1126.........  Endologix, Inc..........  AltoTM Abdominal Stent Graft         3/13/2020
                                                                   System.
P980033/S050, FDA-2020-M-1115.........  Boston Scientific Corp..  VENOUS WALLSTENT.............        3/17/2020
P970051/S172, FDA-2020-M-1116.........  Cochlear Americas.......  Nucleus 24 Cochlear Implant          3/17/2020
                                                                   System.
P190025, FDA-2020-M-1175..............  Abbott Molecular, Inc...  Alinity m HCV................        3/23/2020
P140029/S021, FDA-2020-M-1214.........  Q-Med AB, a Galderma      Restylane[supreg] Kysse......        3/26/2020
                                         affiliate.
P190028, FDA-2020-M-1213..............  Roche Molecular Systems,  cobas HPV for use on the              4/3/2020
                                         Inc.                      cobas 6800/8800 Systems.
P190027, FDA-2020-M-1286..............  Intact Vascular, Inc....  Tack Endovascular                    4/10/2020
                                                                   System[supreg] (4F, 1.5-
                                                                   4.5mm).
P050010/S020, FDA-2020-M-1267.........  Centinel Spine, LLC.....  prodisc[supreg] L Total Disc         4/10/2020
                                                                   Replacement.
P130008/S039, FDA-2020-M-1299.........  Inspire Medical Systems,  Inspire[supreg] Upper Airway         4/14/2020
                                         Inc.                      Stimulation (UAS).

P190026, FDA-2020-M-1290..............  QIAGEN GmbH.............  therascreen[supreg] BRAF             4/15/2020
                                                                   V600E RGQ PCR Kit.
P170019/S013, FDA-2020-M-1300.........  Foundation Medicine, Inc  FoundationOne[supreg] CDx            4/17/2020
                                                                   (F1CDx).
P190015, FDA-2020-M-1311..............  Bolton Medical Inc......  TREO[supreg] Abdominal Stent-         5/4/2020
                                                                   Graft System.
P170019/S011, FDA-2020-M-1358.........  Foundation Medicine, Inc  FoundationOne[supreg] CDx             5/6/2020
                                                                   (F1CDx).
P160028, FDA-2020-M-1367..............  Philips Medical Systems,  HeartStart FR3 Defibrillators        5/11/2020
                                         Inc.                      Models 861388 (Text) and
                                                                   861389 (ECG Display),
                                                                   Primary Battery (Models
<PHONE_NUMBER>61,<PHONE_NUMBER>71),
                                                                   Rechargeable Battery (Model
<PHONE_NUMBER>41), Charger for
                                                                   the Rechargeable Battery
                                                                   (Model 861394), SmartPads
                                                                   III (Models<PHONE_NUMBER>81,
<PHONE_NUMBER>91), DP pads
                                                                   (Models<PHONE_NUMBER>11,
<PHONE_NUMBER>21), and Pediatric
                                                                   Key (Model<PHONE_NUMBER>31).
P180028, FDA-2020-M-1368..............  Philips Medical Systems,  HeartStart FRx Defibrillator         5/11/2020
                                         Inc.                      (861304), Primary Battery
                                                                   (M5070A), Aviation FRx
                                                                   Battery<PHONE_NUMBER>01),
                                                                   SMART Pads II
<PHONE_NUMBER>61), and Infant/
                                                                   Child Key<PHONE_NUMBER>11).
P150025/S013, FDA-2020-M-1410.........  Dako North America, Inc.  PD-L1 IHC 28-8 pharmDx.......        5/15/2020
P170019/S015, FDA-2020-M-1420.........  Foundation Medicine, Inc  FoundationOne[supreg] CDx....        5/19/2020
P110033/S047, FDA-2020-M-1527.........  Allergan................  JUV[Eacute]DERM[supreg]              6/12/2020
                                                                   VOLUMATM XC.
P190021, FDA-2020-M-1583..............  Mainstay Medical Ltd....  ReActiv8 Implantable                 6/16/2020
                                                                   Neurostimulation System.
P170019/S016, FDA-2020-M-1612.........  Foundation Medicine, Inc  FoundationOne[supreg] CDx            6/16/2020
                                                                   (F1CDx).
P200014, FDA-2020-M-1600..............  Roche Molecular Systems,  cobas[supreg] EZH2 Mutation          6/18/2020
                                         Inc.                      Test.
P100010/S098, FDA-2020-M-1613.........  Medtronic, Inc..........  Arctic Front AdvanceTM               6/23/2020
                                                                   Cardiac Cryoablation
                                                                   Catheter Arctic Front
                                                                   Advance ProTM Cardiac
                                                                   Cryoablation Catheters
                                                                   FreezorTM MAX Cardiac
                                                                   Cryoablation Catheter
                                                                   CryoConsole Manual
                                                                   Retraction Kit.
P130013/S035, FDA-2020-M-1715.........  Boston Scientific Corp..  WATCHMAN FLX Left Atrial             7/21/2020
                                                                   Appendage Closure Device
                                                                   with Delivery System and
                                                                   WATCHMAN Left Atrial
                                                                   Appendage Closure Device
                                                                   with Delivery System.
P190031, FDA-2020-M-1724..............  Ventana Medical Systems,  VENTANA HER2 Dual ISH DNA            7/28/2020
                                         Inc.                      Probe Cocktail.
P180031/S001, FDA-2020-M-1726.........  Stryker Neurovascular...  Neuroform Atlas[supreg] Stent        7/30/2020
                                                                   System.
P200010, FDA-2020-M-1748..............  Guardant Health, Inc....  Guardant360[supreg] CDx......         8/7/2020
P190007, FDA-2020-M-1752..............  Cardinal Health.........  KendallTM Multi-Function              8/7/2020
                                                                   Defibrillation Electrodes,
                                                                   Medi-TraceTM Cadence Multi-
                                                                   Function Defibrillation
                                                                   Electrodes, Physio-Control/
                                                                   Stryker QUIK-COMBO Pacing/
                                                                   Defibrillation/ECG
                                                                   Electrodes.
P150003/S058, FDA-2020-M-1760.........  Boston Scientific Corp..  SYNERGYTM Everolimus-Eluting         8/10/2020
                                                                   Platinum Chromium Coronary
                                                                   Stent System (MonorailTM);
                                                                   SYNERGYTM Everolimus-Eluting
                                                                   Platinum Chromium Coronary
                                                                   Stent System (Over-The-
                                                                   WireTM); SYNERGYTM XD
                                                                   Everolimus-Eluting Platinum
                                                                   Chromium Coronary Stent
                                                                   System (MonorailTM).
P190032, FDA-2020-M-1821..............  Foundation Medicine, Inc  FoundationOne Liquid CDx.....        8/26/2020
P180048, FDA-2020-M-1783..............  Diasorin, Inc...........  LIAISON[supreg] XL MUREX             8/29/2020
                                                                   HBeAg, LIAISON[supreg] XL
                                                                   MUREX Control HBeAg.
P180049, FDA-2020-M-1822..............  Diasorin, Inc...........  LIAISON[supreg] XL MUREX anti-       8/29/2020
                                                                   HBe, LIAISON[supreg] XL
                                                                   MUREX Control Anti-HBe.
P180045, FDA-2020-M-1828..............  Diasorin, Inc...........  LIAISON[supreg] XL MUREX HBc         8/29/2020
                                                                   IgM, LIAISON[supreg] XL
                                                                   MUREX Control HBc IgM.
P200013, FDA-2020-M-1830..............  Abbott Molecular, Inc...  Alinity m HBV................        8/29/2020
P190017, FDA-2020-M-1829..............  Diasorin, Inc...........  LIAISON[supreg] XL MUREX             8/29/2020
                                                                   HBsAg Qual; LIAISON[supreg]
                                                                   MUREX Control HBsAg Qual;
                                                                   LIAISON[supreg] XL MUREX
                                                                   HBsAg Confirmatory Test.
P200015, FDA-2020-M-1835..............  Edwards Lifesciences,     Edwards SAPIEN 3                     8/31/2020
                                         LLC.                      Transcatheter Heart Valve
                                                                   System with Edwards
                                                                   Commander Delivery System.
P160017/S076, FDA-2020-M-1838.........  Medtronic Minimed, Inc..  MiniMed 770G System..........        8/31/2020
P140031/S112, FDA-2020-M-1868.........  Edwards Lifesciences,     Edwards SAPIEN 3 and SAPIEN 3         9/9/2020
                                         LLC.                      Ultra Transcatheter Heart
                                                                   Valve System.
P200022, FDA-2020-M-1986..............  Simplify Medical, Inc...  Simplify[supreg] Cervical            9/18/2020
                                                                   Artificial Disc.
P160042/S010, FDA-2020-M-2021.........  Prollenium Medical        Revanesse[supreg] Lips+......        9/21/2020
                                         Technologies, Inc.

H190001, FDA-2020-M-2248..............  HDL Therapeutics, Inc...  Plasma Delipidation System           12/1/2020
                                                                   (PDS-2TM System).
P190030, FDA-2020-M-2288..............  Theragen, Inc...........  ActaStim-S Spine Fusion                12/9/20
                                                                   Stimulator.
P200030, FDA-2020-M-2339..............  W. L. Gore and            GORE[supreg] EXCLUDER[supreg]         12/22/20
                                         Associates, Inc.          Conformable AAA
                                                                   Endoprosthesis (EXCC).
----------------------------------------------------------------------------------------------------------------

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: March 15, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06052 Filed 3-23-21; 8:45 am]
BILLING CODE 4164-01-P


Posey County Wind Rose Analysis  2002 Wind Speed and Wind Direction on 4 Highest 8 hour Ozone Days Maximum 8 hour ozone concentration of 97 ppb Maximum 8 hour ozone concentration of 106 ppb Maximum 8 hour ozone concentration of 99 ppb Maximum 8 hour Ozone concentration of 98 ppb


[Federal Register Volume 82, Number 118 (Wednesday, June 21, 2017)]
[Proposed Rules]
[Pages 28271-28274]
[FR Doc No: 2017-12794]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0563; Directorate Identifier 2017-NM-021-AD]
RIN 2120-AA64

Airworthiness Directives; Saab AB, Saab Aeronautics (Formerly
Known as Saab AB, Saab Aerosystems) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Saab AB, Saab Aeronautics Model 340A (SAAB/SF340A) and SAAB 340B
airplanes. This proposed AD was prompted by the determination that new
inspection tasks for the drag brace support fitting of the main landing
gear (MLG) and corrosion prevention and control program (CPCP) related
tasks are necessary. This proposed AD would require revising the
maintenance or inspection program, as applicable, to incorporate
airworthiness limitations, including new inspection tasks for the drag
brace support fitting of the MLG and to implement CPCP related tasks.
We are proposing this AD to address the unsafe condition on these
products.

DATES: We must receive comments on this proposed AD by August 7, 2017.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Saab AB,
Saab Aeronautics, SE-581 88, Link[ouml]ping, Sweden; telephone +46 13
18 5591; fax +46 13 18 4874; email<EMAIL_ADDRESS>
Internet http://www.saabgroup.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0563; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory 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 FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356;
telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2017-0563;
Directorate Identifier 2017-NM-021-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2017-0033, dated February 17, 2017 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Saab AB, Saab
Aeronautics Model 340A (SAAB/SF340A) and SAAB 340B airplanes. The MCAI
states:

    The airworthiness limitations and/or certification maintenance
instructions for SAAB SF340A and 340B, which are

approved by EASA, are currently defined and published in the SAAB
SF340A and 340B Airworthiness Limitation Manual (ALM). These
instructions have been identified as mandatory for continued
airworthiness.
    Failure to accomplish these instructions could result in an
unsafe condition [reduced structural integrity of the airplane].
    Recently, Saab AB, Aeronautics issued SAAB SF340A and 340B ALM
Revision 1, mainly to add new inspection tasks for the Main Landing
Gear drag brace support fitting, and to implement Corrosion
Prevention and Control Program related tasks.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0563.

Related Service Information Under 1 CFR Part 51

    We reviewed SAAB 340 Airworthiness Limitation Manual, Revision 1,
dated December 1, 2016. The service information describes airworthiness
limitations, including inspection tasks for the drag brace support
fitting of the MLG and CPCP related tasks. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This Proposed AD and the MCAI or Service
Information

    The MCAI specifies that if there are findings from the
airworthiness limitations section (ALS) inspection tasks, corrective
actions must be accomplished in accordance with SAAB maintenance
documentation. However, this proposed AD does not include that
requirement. Operators of U.S.-registered airplanes are required by
general airworthiness and operational regulations to perform
maintenance using methods that are acceptable to the FAA. We consider
those methods to be adequate to address any corrective actions
necessitated by the findings of ALS inspections required by this
proposed AD.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections) and
Critical Design Configuration Control Limitations (CDCCLs). Compliance
with these actions and CDCCLs is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance according to paragraph
(i)(1) of this proposed AD. The request should include a description of
changes to the required actions that will ensure the continued damage
tolerance of the affected structure.

Airworthiness Limitations Based on Type Design

    The FAA recently became aware of an issue related to the
applicability of ADs that require incorporation of an ALS revision into
an operator's maintenance or inspection program.
    Typically, when these types of ADs are issued by civil aviation
authorities of other countries, they apply to all airplanes covered
under an identified type certificate (TC). The corresponding FAA AD
typically retains applicability to all of those airplanes.
    In addition, U.S. operators must operate their airplanes in an
airworthy condition, in accordance with 14 CFR 91.7(a). Included in
this obligation is the requirement to perform any maintenance or
inspections specified in the ALS, and in accordance with the ALS as
specified in 14 CFR 43.16 and 91.403(c), unless an alternative has been
approved by the FAA.
    When a type certificate is issued for a type design, the specific
ALS, including revisions, is a part of that type design, as specified
in 14 CFR 21.31(c).
    The sum effect of these operational and maintenance requirements is
an obligation to comply with the ALS defined in the type design
referenced in the manufacturer's conformity statement. This obligation
may introduce a conflict with an AD that requires a specific ALS
revision if new airplanes are delivered with a later revision as part
of their type design.
    To address this conflict, the FAA has approved alternative methods
of compliance (AMOCs) that allow operators to incorporate the most
recent ALS revision into their maintenance/inspection programs, in lieu
of the ALS revision required by the AD. This eliminates the conflict
and enables the operator to comply with both the AD and the type
design.
    However, compliance with AMOCs is normally optional, and we
recently became aware that some operators choose to retain the AD-
mandated ALS revision in their fleet-wide maintenance/inspection
programs, including those for new airplanes delivered with later ALS
revisions, to help standardize the maintenance of the fleet. To ensure
that operators comply with the applicable ALS revision for newly
delivered airplanes containing a later revision than that specified in
an AD, we plan to limit the applicability of ADs that mandate ALS
revisions to those airplanes that are subject to an earlier revision of
the ALS, either as part of the type design or as mandated by an earlier
AD.
    This proposed AD therefore would apply to Model 340A (SAAB/SF340A)
and SAAB 340B airplanes with an original certificate of airworthiness
or original export certificate of airworthiness that was issued on or
before the date of approval of the ALS revision identified in this
proposed AD. Operators of airplanes with an original certificate of
airworthiness or original export certificate of airworthiness issued
after that date must comply with the airworthiness limitations
specified as part of the approved type design and referenced on the
type certificate data sheet.

Costs of Compliance

    We estimate that this proposed AD affects 87 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on  U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Revision of the airplane maintenance    1 work-hour x $85 per                 $0             $85          $7,395
 or inspection program.                  hour = $85.
----------------------------------------------------------------------------------------------------------------

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 above, 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; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

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 adding the following new airworthiness
directive (AD):

Saab AB, Saab Aeronautics (Formerly Known as Saab AB, Saab
Aerosystems): Docket No. FAA-2017-0563; Directorate Identifier 2017-
NM-021-AD.

(a) Comments Due Date

    We must receive comments by August 7, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Saab AB, Saab Aeronautics (formerly known as
Saab AB, Saab Aerosystems) Model 340A (SAAB/SF340A) and SAAB 340B
airplanes, certificated in any category, with an original
certificate of airworthiness or original export certificate of
airworthiness that was issued on or before December 1, 2016.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by the determination that new inspection
tasks for the drag brace support fitting of the main landing gear
(MLG) and corrosion prevention and control program (CPCP) related
tasks are necessary. We are issuing this AD to prevent reduced
structural integrity of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Maintenance or Inspection Program Revision

    Within 30 days after the effective date of this AD: Revise the
maintenance or inspection program, as applicable, to incorporate
airworthiness limitations, including inspection tasks for the drag
brace support fitting of the MLG and CPCP related tasks, specified
in SAAB 340 Airworthiness Limitation Manual, Revision 1, dated
December 1, 2016. The compliance time for the initial airworthiness
limitation tasks is at the applicable compliance time specified in
SAAB 340 Airworthiness Limitation Manual, Revision 1, dated December
1, 2016, or within 30 days after the effective date of this AD,
whichever occurs later.

(h) No Alternative Actions, Intervals, Critical Design Configuration
Control Limitations (CDCCLs)

    After the maintenance or inspection program, as applicable, has
been revised as required by paragraph (g) of this AD, no alternative
actions (e.g., inspections), intervals, and/or CDCCLs may be used
unless the actions, intervals, and/or CDCCLs are approved as an
alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (i)(1) of this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
International Branch, send it to the attention of the person
identified in paragraph (j)(2) of this AD. Information may be
emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Saab AB, Saab
Aeronautics's EASA Design Organization Approval (DOA). If approved
by the DOA, the approval must include the DOA-authorized signature.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2017-0033, dated February 17,
2017, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2017-0563.
    (2) For more information about this AD, contact Shahram
Daneshmandi, Aerospace Engineer, International Branch, ANM-116,

Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
    (3) For service information identified in this AD, contact Saab
AB, Saab Aeronautics, SE-581 88, Link[ouml]ping, Sweden; telephone
+46 13 18 5591; fax +46 13 18 4874; email
<EMAIL_ADDRESS>Internet http://www.saabgroup.com.
You may view this service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on June 12, 2017.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-12794 Filed 6-20-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Rules and Regulations]
[Pages 10015-10016]
[FR Doc No: 2021-03032]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2018-0062; FRL-10018-22-Region 10]

Air Plan Approval; Washington; Interstate Transport Requirements
for the 2010 Sulfur Dioxide National Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving the
State Implementation Plan (SIP) revisions submitted by Washington on
February 7, 2018 as meeting certain Clean Air Act (CAA) requirements
for interstate transport of the 2010 1-hour Sulfur Dioxide
(SO2) National Ambient Air Quality Standards (NAAQS). The
EPA has determined that emissions from Washington sources will not
contribute significantly to nonattainment or interfere with the
maintenance of the 2010 1-hour SO2 NAAQS in any other state.

DATES: This final rule is effective March 22, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R10-OAR-2018-0062. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information or other information the disclosure
of which is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available at https://www.regulations.gov, or please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section for additional availability information.

FOR FURTHER INFORMATION CONTACT: John Chi, EPA Region 10, Air and
Radiation Division, 1200 Sixth Avenue--Suite 155, Seattle, WA 98101, at
206-553-1185, or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, wherever ``we'',
``us'', or ``our'' is used, it means the EPA.

I. Background

    On July 27, 2020, the EPA proposed to approve the February 7, 2018
SIP submission from Washington as meeting certain Clean Air Act (CAA)
interstate transport requirements for the 2010 1-hour SO2
NAAQS (85 FR 45146). The reasons for our proposed approval were stated
in the proposed rulemaking and will not be re-stated here. The public
comment period for the proposed rulemaking was reopened on September
22, 2020 (85 FR 59486), due to an incorrect docket number, and closed
on October 22, 2020. We received no comments. Therefore, we are
finalizing our rulemaking as proposed.

II. Final Action

    In this final action, the EPA is approving the February 7, 2018 SIP
submission from Washington as meeting the interstate transport
requirements of CAA section 110(a)(2)(D)(i)(I) for the 2010 1-hour
SO2 NAAQS.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of the requirements would be inconsistent
with the CAA; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this final action does not apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by April 19, 2021. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2)).

List of Subjects in 40 CFR Part 52

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

    Dated: February 9, 2021.
Michelle L. Pirzadeh,
Acting Regional Administrator, Region 10.

    For the reasons set forth in the preamble, 40 CFR part 52 is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for Part 52 continues to read as follows:

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

Subpart WW--Washington

0
2. In Sec.  52.2470, Table 2 in paragraph (e) is amended by adding an
entry for ``Interstate Transport for the 2010 SO2 NAAQS''
immediately below the entry ``Interstate Transport for the 2015 Ozone
NAAQS'' to read as follows:

Sec.  52.2470  Identification of plan.

* * * * *
    (e) * * *

                                Table 2--Attainment, Maintenance, and Other Plans
----------------------------------------------------------------------------------------------------------------
                                     Applicable
     Name of SIP provision          geographic or         State       EPA approval date        Explanations
                                 nonattainment area  submittal date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                110(a)(2) Infrastructure and Interstate Transport
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Interstate Transport for the     Statewide.........        2/7/2018  2/18/2021, [Insert  This action addresses
 2010 SO2 NAAQS.                                                      Federal Register    CAA
                                                                      citation].          110(a)(2)(D)(i)(I).

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2021-03032 Filed 2-17-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 20, 2009 (Volume 74, Number 96)]
[Notices]
[Page 23690]
[DOCID:fr20my09-43]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-R05-OAR-2009-0221, EPA-R05-OAR-2009-0220; FRL-8907-2]

Adequacy Status of the Cleveland/Akron, Ohio and the Columbus,
Ohio Submitted 8-Hour Ozone Redesignation and Maintenance Plans for
Transportation Conformity Purposes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of adequacy.

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

SUMMARY: In this notice, EPA is notifying the public that we have found
that the motor vehicle emissions budgets (MVEBs) for volatile organic
compounds (VOC) and oxides of nitrogen (NOX) in the
Cleveland/Akron, Ohio area and the Columbus, Ohio area are adequate for
use in transportation conformity determinations. Ohio submitted the
Cleveland/Akron area budgets with an 8-hour ozone redesignation and
maintenance plan on March 17, 2009. Ohio submitted the Columbus area
budgets with an 8-hour ozone redesignation and maintenance plan on
March 17, 2009. As a result of our finding, the Cleveland/Akron, Ohio
area and the Columbus, Ohio area must use the MVEBs from the submitted
8-hour ozone maintenance plan for future transportation conformity
determinations.

DATES: This finding is effective June 4, 2009.

FOR FURTHER INFORMATION CONTACT: Anthony Maietta, Life Scientist,
Criteria Pollutant Section (AR-18J), Air Programs Branch, Air and
Radiation Division, United States Environmental Protection Agency,
Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312)
353-8777<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we,''
``us'' or ``our'' is used, we mean EPA.

Background

    Today's notice is simply an announcement of a finding that we have
already made. On March 30, 2009, EPA Region 5 sent a letter to the Ohio
Environmental Protection Agency stating that the 2010 and 2020 MVEBs
for the Cleveland/Akron area, and also for the Columbus area, which
were submitted with the state's 8-hour ozone redesignation and
maintenance plan, are adequate. Receipt of these MVEBs was announced on
EPA's transportation conformity website, and no comments were
submitted. The finding is available at EPA's conformity Web site:
http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm.
    The adequate 2010 and 2020 MVEBs, in tons per day (tpd), for VOC
and NOX for the Cleveland/Akron area are as follows:

------------------------------------------------------------------------
                                                 2012 MVEB    2020 MVEB
                                                   (tpd)        (tpd)
------------------------------------------------------------------------
VOC...........................................        46.64        31.48
NOX...........................................        95.89        42.75
------------------------------------------------------------------------

    The adequate 2010 and 2020 MVEBs, in tons per day (tpd), for VOC
and NOX for the Columbus area are as follows:

------------------------------------------------------------------------
                                                 2012 MVEB    2020 MVEB
                                                   (tpd)        (tpd)
------------------------------------------------------------------------
VOC...........................................        54.86        36.60
NOX...........................................        91.64        46.61
------------------------------------------------------------------------

    Please note that the March 30, 2009, letter to the state had the
budgets in the wrong columns and this has been corrected in this
notice.
    Transportation conformity is required by section 176(c) of the
Clean Air Act. EPA's conformity rule requires that transportation
plans, programs, and projects conform to state air quality
implementation plans and establishes the criteria and procedures for
determining whether or not they do conform. Conformity to a State
Implementation Plan (SIP) means that transportation activities will not
produce new air quality violations, worsen existing violations, or
delay timely attainment of the national ambient air quality standards.
    The criteria by which we determine whether a SIP's motor vehicle
emission budgets are adequate for transportation conformity purposes
are outlined in 40 CFR 93.118(e)(4). We have described our process for
determining the adequacy of submitted SIP budgets in our July 1, 2004,
preamble starting at 69 FR 40038, and we used the information in these
resources while making our adequacy determination. Please note that an
adequacy review is separate from EPA's completeness review, and it also
should not be used to prejudge EPA's ultimate approval of the SIP. Even
if we find a budget adequate, the SIP could later be disapproved.
    The finding and the response to comments are available at EPA's
transportation conformity web site: http://www.epa.gov/otaq/
stateresources/transconf/adequacy.htm.

    Authority:  42 U.S.C. 7401-7671q.

    Dated: May 7, 2009.
Walter W. Kovalick Jr,
Acting Regional Administrator, Region 5.
[FR Doc. E9-11639 Filed 5-19-09; 8:45 am]

BILLING CODE 6560-50-P


From:
D'Angelo, Wayne J<EMAIL_ADDRESS>Sent:
Jones, DonnaLee<EMAIL_ADDRESS>To:
Tuesday, April 27, 2021 5:26 PM
Cc:
Stuart, Eric<EMAIL_ADDRESS>Green, Joseph J<EMAIL_ADDRESS>Subject:
RE: expanded list of false alarms - One more thing

No problem at all.  It's your job to ask questions and it's my job to answer them as best I can.
Best,
Wayne

WAYNE D'ANGELO

Kelley Drye & Warren LLP
Tel:<PHONE_NUMBER>
Cell:<PHONE_NUMBER>

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Tuesday, April 27, 2021 4:46 PM
To: D'Angelo, Wayne J<EMAIL_ADDRESS>Cc: Stuart, Eric<EMAIL_ADDRESS>Green, Joseph J<EMAIL_ADDRESS>Subject: RE: expanded list of false alarms - One more thing

Thanks again. Hopefully, this will be the end of my questions for a while. You have been very tolerant. I appreciate it.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: D'Angelo, Wayne J<EMAIL_ADDRESS>Sent: Tuesday, April 27, 2021 4:27 PM
To: Jones, DonnaLee<EMAIL_ADDRESS>Cc: Stuart, Eric<EMAIL_ADDRESS>Green, Joseph J<EMAIL_ADDRESS>Subject: RE: expanded list of false alarms - One more thing

Dr. Jones,  I cannot speak to the frequency of false and positive alarms but I will ask around to see if I can give you some reasonable estimates.
Best,
Wayne

WAYNE D'ANGELO

Kelley Drye & Warren LLP
Tel:<PHONE_NUMBER>
Cell:<PHONE_NUMBER>

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Tuesday, April 27, 2021 4:07 PM
To: D'Angelo, Wayne J<EMAIL_ADDRESS>Cc: Stuart, Eric<EMAIL_ADDRESS>Green, Joseph J<EMAIL_ADDRESS>Subject: RE: expanded list of false alarms - One more thing

I forgot to ask how often, on a broad-scale average, do facilities have to chase down a false alarm? If its possible, include also the number, on average, of real alarms related to leaks? You can estimate on whatever time basis that makes sense, i.e., weekly, monthly, yearly. From this we also will see the % of alarms that are false.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: Jones, DonnaLee
Sent: Tuesday, April 27, 2021 3:51 PM
To: D'Angelo, Wayne J<EMAIL_ADDRESS>Cc: Stuart, Eric<EMAIL_ADDRESS>Green, Joseph J<EMAIL_ADDRESS>Subject: RE: expanded list of false alarms

This additional information also is helpful. I will circle back with you when I develop a draft list, possibly after discussion with my team.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: D'Angelo, Wayne J<EMAIL_ADDRESS>Sent: Tuesday, April 27, 2021 3:38 PM
To: Jones, DonnaLee<EMAIL_ADDRESS>Cc: Stuart, Eric<EMAIL_ADDRESS>Green, Joseph J<EMAIL_ADDRESS>Subject: RE: expanded list of false alarms

I really can't estimate the percentage of false/nuisance alarms this would cover, but these are likely only a subset of the false/nuisance alarms facilities encounter.  We limited our list to those types of instances where the operator could directly correlate an BLDS alarm to a condition other than a broken, leaking, or dislodged bag.  A significant number of BLDS alarms are only triggered momentarily and for reasons that may not be ascertainable.  For instance, a larger chunk of caked up or accumulated dust can break off at any point in the normal course of operating the baghouse and trigger a BLDS alarm.  It may be impossible to definitively determine that a dislodged dust accumulation caused the brief alarm, but the operator could still use a visual emissions observation and BLDS readout data to determine that there is no broken, leaking, or dislodged bag.   Indeed, for the overall class of short-lived nuisance alarms that cannot be correlated to any of the potential causes/conditions I described in my prior email, I suspect the primary means by which facilities would determine that a momentary alarm was not caused by a broken, leaking, or dislodged bag is to conduct a visual observation/inspection and confirm through readout data that particulate loading levels are normal.

To your question about whether facilities can live with an explicit list, I am not sure I understand how the list will be used.  Am I correct that the "list" is referring to various ways a facility can use "operator's knowledge or other acceptable means" to determine that a BLDS alarm was not caused by a broken, leaking, or deislodged bag?   If so, I would say the list should broadl include: (1) alarm-triggering actions/event/conditions that can be correlated to the BLDS alarm and which do not involve broken, leaking, or dislodged bags (this broadly emompasses everything in my previous email); (2) VE observations; (3) BLDS readout data that shows the alarm was short-lived and particulate loads normalized; (4) physcial observations and maintenance inspections.
Please let me know if I've not answered your question or if this doesn't make sense.  I'm also happy to discuss.
Best,
Wayne
WAYNE D'ANGELO

Kelley Drye & Warren LLP
Tel:<PHONE_NUMBER>
Cell:<PHONE_NUMBER>

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Tuesday, April 27, 2021 2:06 PM
To: D'Angelo, Wayne J<EMAIL_ADDRESS>Cc: Stuart, Eric<EMAIL_ADDRESS>Green, Joseph J<EMAIL_ADDRESS>Subject: RE: expanded list of false alarms

Thank you. Fantastic descriptions. So if we add these instances to the rule, will this cover 99.9% of the reasons for false alarms, along with items already listed in that section of the rule? In other words, could the facilities live with this explicit list (added to what's already in the rule)?

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: D'Angelo, Wayne J<EMAIL_ADDRESS>Sent: Tuesday, April 27, 2021 1:23 PM
To: Jones, DonnaLee<EMAIL_ADDRESS>Cc: Stuart, Eric<EMAIL_ADDRESS>Green, Joseph J<EMAIL_ADDRESS>Subject: RE: expanded list of false alarms

Hello Dr. Jones.  I connected with a few environmental managers in the EAF steel industry in order to compile a more extensive list of reasons a BLDS can alarm intermittently and/or when there is no excess emissions or system malfunctions.   Below are a few examples and my best attempt to categorize them:

1.            Weather  -  As noted in our prior response, BLDS alarms will occasionally trigger during a heavy downpour or when there are significant changes in temperature or humidity.  Operators can confirm these alarms were not caused by broken bags or bag leaks by correlating the alarm to any significant weather conditions/changes at the time, through visual opacity observations, and through review of the BLDS readout to confirm a return to normal particulate loading following the triggering weather condition.

2.            Bag Cleaning Cycle  -  As noted in our prior response and in EPA's BLDS guidance, a BLDS may briefly alarm when the system comes out of a cleaning cycle.  Most often, this is due to the temporary absence of dust in the bags, which acts as an additional filter medium.  Operators can confirm these alarms were not caused by broken bags or bag leaks through visual opacity observations and through review of the BLDS readout to confirm a return to normal particulate loading as the bags re-accumulate dust.

3.            New Bag Start  -  Similar to #2 above, BLDS alarms can be triggered immediately following a replacement of some or all of the bags in the baghouse.  These alarms typically cease shortly after the restart as the new bags accumulate dust that acts as an additional filer medium. Operators can confirm these alarms were not caused by broken bags or bag leaks by correlating the alarm to the new bags, conducting visual opacity observations, and reviewing the BLDS readout to confirm a return to normal particulate loading as the new bags accumulate dust.

4.            Systems Checks/Testing  -  Some facilities may run systems checks on their BLDS that cause the system to alarm.  For example, a facility can check the sensitivity of a BLDS by introducing a handful of flour into a port upstream from the probe.  In this example, the BLDS alarm will trigger briefly, but the operator conducting the test will surely know that the alarm was not caused by a broken bag or bag leak.  Facilities also evaluate and optimize their BLDS performance through drift checks, response tests, calibration exercises, and other quality assurance procedures.  Some of these procedures require the alarm to be triggered in order to test performance, but in other instances the BLDS alarm may be inadvertently triggered during testing.  Regardless whether the systems check/testing alarm is triggered purposely or inadvertently, the operator can readily correlate the alarm with the systems check, and can confirm through visual observation or otherwise that the alarm was not additionally caused by a broken, leaking, or dislodged bag.

5.            Electrical Malfunctions  -  As BLDS detection is based on contact electrification, alarms can be triggered due to electrical surges impacting the sensors, processing electronics, or the connections between the sensor and processing electronics.  These surges can either be environmental (lightning) or from variations/malfunctions in the BLDS system, its software, or its power source.   Additionally, the abrasive environment in the baghouse duct can deteriorate the probe, probe housing, and housing insulation, which can cause an increase in malfunctions.  The alarms associated with these malfunctions/deterioration may provide the operator notice of the need for repair/maintenance, but they are not reliable indicators of broken, dislodged, or leaking bags.

BLDS can also experience electrical malfunctions and software glitches no different than many other types of electrical equipment.  BLDS alarms may be triggered during temporary power lapses or brief connectivity issues between the sensor and the processing electrics, or between the processing electronics and the system output/alarm.    Like any piece of electrical equipment, BLDS can experience brief mechanical or software glitches/errors, including with respect to the sensor's signal amplification or with the configuration of the processing electronics.  In many cases, momentary electrical malfunctions or glitches will cause the BLDS to alarm only briefly, and operators can confirm that these types of alarms were not caused by broken bags or bag leaks by conducting a visual emissions observation, correlating the alarm to a known surge or observable electrical malfunction, reviewing the system readout to confirm no increase in pollutant loading, or through use of other means.

6.            Repair/Maintenance  -   Some baghouse repair and maintenance activities may be conducted while the baghouse is in operation.  In some cases, proper inspection and repair requires the baghouse to be operating in order to observe and repair malfunctions/maintenance issues.  Often these activities are coordinated with a baghouse operator observing the BLDS readout in real time into order to identify the cause of an earlier alarm or to proactively identify maintenance or performance issues.  In other circumstances, baghouse repair and maintenance activities must be conducted when the baghouse is operating simply because the repair/maintenance is urgently needed and it is infeasible to quickly shut down the baghouse.   Regardless of the specific reason for conducting repair/maintenance activities while the baghouse is operating, it is often the case that these activities will cause BLDS alarms.  As workers open and manipulate compartments and conveyances they can introduce particulates into the system or dislodge caked or accumulated dust.  Some maintenance and repair activities can also directly interfere with the BLDS causing it to trigger.   As these maintenance and repair activities are conducted in conjunction with the baghouse operator, the operator can readily correlate a BLDS alarm to a repair activity occurring at that time.  Moreover, because maintenance personal are directly observing baghouse compartments during alarms such as these, they are in a position to fully confirm that the alarms were not caused by broken, leaking, or dislodged bags.

BLDS alarms can also be caused by maintenance and repair activities conducted when the baghouse is not operating.  These activities can introduce foreign material or dislodge accumulations of material from ducts, conveyances, access panels, joints, and other components of the system upstream from the probe.  When the baghouse restarts after such repair and maintenance activities, the newly introduced or dislodged material can cause the BLDS alarm to briefly signal.   Because the operator will know (from direct knowledge or review of the baghouse maintenance log) that these dust-generating activities were conducted in the baghouse while it was idled, the operator can correlate a short-lived alarm upon restart with those maintenance/repair activities.  This correlation can be confirmed through visual opacity observations and review of the BLDS readout to confirm a rapid return to normal particulate loading.

Please let me know if you have any questions or want to discuss.  I am still waiting to hear back from a few contacts regarding your questions.  If I receaive any additional informaiton, examples, or better insights in how to best categorize these types of alarms, I will supplement this response.
Thanks for the opportunity to provide this and please do not hesitate to reach out if we can help in any other way.
Best,
Wayne
WAYNE D'ANGELO

Kelley Drye & Warren LLP
Tel:<PHONE_NUMBER>
Cell:<PHONE_NUMBER>

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Thursday, April 8, 2021 6:56 PM
To: D'Angelo, Wayne J<EMAIL_ADDRESS>Cc: Stuart, Eric<EMAIL_ADDRESS>Green, Joseph J<EMAIL_ADDRESS>Subject: expanded list of false alarms

Hi. Back again. I will need an expanded list of reasons for BLDS false alarms and/or intermittent alarms. I noticed that one reason on your list was already on the response list in the rule: §60.273a (f)(5) Cleaning the bag leak detection system probe or otherwise repairing the bag leak detection system.

If you can think of category names for groups of two or more items on your list of things that cause false alarms, that would be helpful, e.g., a heading of "weather" and item list of things that cause false alarms to include heavy rain and changes in temperature or humidity.

The issue here is not 3 hours vs 24 hours, but documentation of the cause of the alarm (and also the response under 273a(f)(5)), when it is a false alarm and, therefore, no response in terms of stopping a leak is possible.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.