[Federal Register Volume 88, Number 150 (Monday, August 7, 2023)]
[Notices]
[Pages 52173-52179]
[FR Doc No: 2023-16770]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]

Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 060

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
Recognized Consensus Standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 060'' (Recognition List Number: 060), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.

DATES: Submit either electronic or written comments on the notice at
any time. These modifications to the list of recognized standards are
applicable August 7, 2023.

ADDRESSES: You may submit comments on the current list of FDA
Recognized Consensus Standards at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for

information submitted, marked and identified, as confidential, if
submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of
1997: Modifications to the List of Recognized Standards, Recognition
List Number: 060.'' 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,<PHONE_NUMBER>.
FDA will consider any comments received in determining whether to amend
the current listing of modifications to the list of recognized
standards, Recognition List Number: 060.
     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>.
    An electronic copy of Recognition List Number: 060 is available on
the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section IV for
electronic access to the searchable database for the current list of
FDA-recognized consensus standards, including Recognition List Number:
060 modifications and other standards-related information. Submit
written requests for a single hard copy of the document entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 060'' to Jianchao Zeng, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5572, Silver Spring, MD 20993,<PHONE_NUMBER>. Send one self-
addressed adhesive label to assist that office in processing your
request, or Fax your request to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jianchao Zeng, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514
of the FD&C Act allows FDA to recognize consensus standards developed
by international and national organizations for use in satisfying
portions of device premarket review submissions or other requirements.
    In the Federal Register of September 14, 2018 (83 FR 46738), FDA
announced the availability of a guidance entitled ``Appropriate Use of
Voluntary Consensus Standards in Premarket Submissions for Medical
Devices.'' The guidance describes how FDA has implemented its standards
recognition program and is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices.
Modifications to the initial list of recognized standards, as published
in the Federal Register, can be accessed at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.
    These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains on its
website HTML and PDF versions of the list of FDA Recognized Consensus
Standards, available at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.
Additional information on the Agency's Standards and Conformity
Assessment Program is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program.

II. Modifications to the List of Recognized Standards, Recognition List
Number: 060

    FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency is recognizing for
use in premarket submissions and other requirements for devices. FDA is
incorporating these modifications to the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA is using
the term ``Recognition List Number: 060'' to identify the current
modifications.
    In table 1, FDA describes the following modifications: (1) the
withdrawal of standards and their replacement by others, if applicable;
(2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
    In section III, FDA lists modifications the Agency is making that
involve new entries and consensus standards added as modifications to
the list of recognized standards under Recognition List Number: 060.

       Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
                   Replacement
 Old recognition   recognition   Title of standard \1\       Change
       No.             No.
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
1-127...........         1-161  ISO 16628 Second        Withdrawn and
                                 edition 2022-06         replaced with
                                 Anaesthetic and         newer version.
                                 respiratory
                                 equipment--Tracheobro
                                 nchial tubes.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
2-213...........         2-299  ASTM F1904-23 Standard  Withdrawn and
                                 Guide for Testing the   replaced with
                                 Biological Responses    newer version.
                                 to Medical Device
                                 Particulate Debris
                                 and Degradation
                                 Products in vivo.
2-222...........         2-300  ISO 10993-2 Third       Withdrawn and
                                 edition 2022-11         replaced with
                                 Biological evaluation   newer version.
                                 of medical devices--
                                 Part 2: Animal
                                 welfare requirements.
2-227...........         2-301  ASTM F1983-23 Standard  Withdrawn and
                                 Practice for            replaced with
                                 Assessment of           newer version.
                                 Selected Tissue
                                 Effects of Absorbable
                                 Biomaterials for
                                 Implant Applications.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-87............         3-184  ASTM F2477-23 Standard  Withdrawn and
                                 Test Methods for in     replaced with
                                 vitro Pulsatile         newer version.
                                 Durability Testing of
                                 Vascular Stents and
                                 Endovascular
                                 Prostheses.
------------------------------------------------------------------------
                  D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-86............  ............  ANSI/ADA Standard No.   Withdrawn.
                                 38-2000 (R2015) Metal-
                                 Ceramic Dental
                                 Restorative Systems.
4-139...........  ............  ANSI/ADA Standard No.   Withdrawn.
                                 48-2004 (R2015)
                                 Visible Light Curing
                                 Units.
4-181...........         4-298  ISO 4049 Fifth edition  Withdrawn and
                                 2019-05 Dentistry--     replaced with
                                 Polymer-based           newer version.
                                 restorative materials.
4-198...........         4-299  ISO 3107 Fifth edition  Withdrawn and
                                 2022-09 Dentistry--     replaced with
                                 Zinc oxide-eugenol      newer version.
                                 cements and non-
                                 eugenol zinc oxide
                                 cements.
4-227...........         4-300  ISO 22674 Third         Withdrawn and
                                 edition 2022-08         replaced with
                                 Dentistry--Metallic     newer version.
                                 materials for fixed
                                 and removable
                                 restorations and
                                 appliances.
4-231...........  ............  ISO/TS 11405 Third      Withdrawn.
                                 edition 2015-02-01
                                 Dentistry--Testing of
                                 adhesion to tooth
                                 structure.
4-240...........         4-301  ISO 21563 Second        Withdrawn and
                                 edition 2021-08         replaced with
                                 Dentistry--Hydrocollo   newer version.
                                 id impression
                                 materials.
4-248...........         4-302  ISO 10477 Fourth        Withdrawn and
                                 edition 2020-10         replaced with
                                 Dentistry--Polymer-     newer version.
                                 based crown and
                                 veneering materials.
4-249...........  ............  ANSI/ADA Standard No.   Withdrawn.
                                 19-2018 Elastometric
                                 Impression Materials.
4-253...........  ............  ANSI/ADA Standard No.   Withdrawn. See 4-
                                 27-2016 Polymer-based   298.
                                 Restorative Materials.
4-264...........         4-303  ISO 9333 Third edition  Withdrawn and
                                 2022-08 Dentistry--     replaced with
                                 Brazing materials.      newer version.
4-267...........         4-304  ISO 21606 Second        Withdrawn and
                                 edition 2022-08         replaced with
                                 Dentistry--Elastomeri   newer version.
                                 c auxiliaries for use
                                 in orthodontics.
------------------------------------------------------------------------
         E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-34...........  ............  IEC 61010-1 Edition     Recognition
                                 3.1 2017-01             restored.
                                 CONSOLIDATED VERSION
                                 Safety requirements
                                 for electrical
                                 equipment for
                                 measurement, control,
                                 and laboratory use--
                                 Part 1: General
                                 requirements
                                 [Including:
                                 Corrigendum 1 (2019)].
------------------------------------------------------------------------
          G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-253...........         6-486  ISO 10535 Third         Withdrawn and
                                 Edition 2021-10         replaced with
                                 Assistive products--    newer version.
                                 Hoists for the
                                 transfer of persons--
                                 Requirements and test
                                 methods.
6-296...........         6-487  AAMI PB70:2022 Liquid   Withdrawn and
                                 barrier performance     replaced with
                                 and classification of   newer version.
                                 protective apparel
                                 and drapes intended
                                 for use in health
                                 care facilities.
6-306...........         6-488  ASTM F1671/F1671M-22    Withdrawn and
                                 Standard Test Method    replaced with
                                 for Resistance of       newer version.
                                 Materials Used in
                                 Protective Clothing
                                 to Penetration by
                                 Blood-Borne Pathogens
                                 Using Phi-X174
                                 Bacteriophage
                                 Penetration as a Test
                                 System.
6-321...........         6-489  IEC 60601-2-52 Edition  Withdrawn and
                                 1.1 2015-03             replaced with
                                 CONSOLIDATED VERSION    newer version.
                                 Medical electrical
                                 equipment--Part 2-52:
                                 Particular
                                 requirements for the
                                 basic safety and
                                 essential performance
                                 of medical beds.
6-357...........         6-490  ISO 10555-6 First       Withdrawn and
                                 edition 2015-04-15      replaced with
                                 Intravascular           newer version.
                                 catheters--Sterile
                                 and single-use
                                 catheters--Part 6:
                                 Subcutaneous
                                 implanted ports
                                 [Including Amendment
                                 1 (2019)].
6-402...........         6-491  ASTM F1670/F1670M-17a   Withdrawn and
                                 Standard Test Method    replaced with
                                 for Resistance of       newer version.
                                 Materials Used in
                                 Protective Clothing
                                 to Penetration by
                                 Synthetic Blood.

6-425...........         6-492  ASTM F2100-23 Standard  Withdrawn and
                                 Specification for       replaced with
                                 Performance of          newer version.
                                 Materials Used in
                                 Medical Face Masks.
6-427...........         6-493  ASTM F2101-23 Standard  Withdrawn and
                                 Test Method for         replaced with
                                 Evaluating the          newer version.
                                 Bacterial Filtration
                                 Efficiency (BFE) of
                                 Medical Face Mask
                                 Materials, Using a
                                 Biological Aerosol of
                                 Staphylococcus aureus.
6-474...........         6-494  ASTM F3352/F3352M-23a   Withdrawn and
                                 Standard                replaced with
                                 Specification for       newer version.
                                 Isolation Gowns
                                 Intended for Use in
                                 Healthcare Facilities.
------------------------------------------------------------------------
                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-152...........         7-315  CLSI EP12 3rd Edition   Withdrawn and
                                 Evaluation of           replaced with
                                 Qualitative, Binary     newer version.
                                 Output Examination
                                 Performance.
7-244...........         7-316  CLSI NBS01 7th Edition  Withdrawn and
                                 Dried Blood Spot        replaced with
                                 Specimen Collection     newer version.
                                 for Newborn Screening.
7-308...........         7-317  CLSI M100, 33rd         Withdrawn and
                                 Edition Performance     replaced with
                                 Standards for           newer version.
                                 Antimicrobial
                                 Susceptibility
                                 Testing.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-200...........         8-597  ASTM F2003-02(2022)     Withdrawn and
                                 Standard Practice for   replaced with
                                 Accelerated Aging of    newer version.
                                 Ultra-High Molecular
                                 Weight Polyethylene
                                 After Gamma
                                 Irradiation in Air.
8-441...........         8-598  ASTM F3109-22 Standard  Withdrawn and
                                 Practice for            replaced with
                                 Verification of Multi-  newer version.
                                 Axis Force Measuring
                                 Platforms.
8-453...........         8-599  ASTM F1295-22 Standard  Withdrawn and
                                 Specification for       replaced with
                                 Wrought Titanium-       newer version.
                                 6Aluminum-7Niobium
                                 Alloy for Surgical
                                 Implant Applications
                                 (UNS R56700).
8-467...........         8-600  ASTM F1978-22 Standard  Withdrawn and
                                 Test Method for         replaced with
                                 Measuring Abrasion      newer version.
                                 Resistance of
                                 Metallic Thermal
                                 Spray Coatings by
                                 Using the Taber
                                 Abraser.
8-506...........         8-601  ASTM F2516-22 Standard  Withdrawn and
                                 Test Method for         replaced with
                                 Tension Testing of      newer version.
                                 Nickel-Titanium
                                 Superelastic
                                 Materials.
8-528...........         8-602  ASTM F2503-23 Standard  Withdrawn and
                                 Practice for Marking    replaced with
                                 Medical Devices and     newer version.
                                 Other Items for
                                 Safety in the
                                 Magnetic Resonance
                                 Environment.
8-555...........         8-603  ASTM F1472-23 Standard  Withdrawn and
                                 Specification for       replaced with
                                 Wrought Titanium-       newer version.
                                 6Aluminum-4Vanadium
                                 Alloy for Surgical
                                 Implant Applications
                                 (UNS R56400).
------------------------------------------------------------------------
                            J. Nanotechnology
------------------------------------------------------------------------
18-15...........         18-23  ASTM E3025-22 Standard  Withdrawn and
                                 Guide for Tiered        replaced with
                                 Approach to Detection   newer version.
                                 and Characterization
                                 of Silver
                                 Nanomaterials in
                                 Textiles.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
  L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
9-67............         9-145  ASTM D7661-18 Standard  Withdrawn and
                                 Test Method for         replaced with
                                 Determining             newer version.
                                 Compatibility of
                                 Personal Lubricants
                                 with Natural Rubber
                                 Latex Condoms.
9-94............         9-146  ISO 8600-4 Third        Withdrawn and
                                 Edition 2023-01         replaced with
                                 Endoscopes--Medical     newer version.
                                 endoscopes and
                                 endotherapy devices--
                                 Part 4: Determination
                                 of maximum width of
                                 insertion portion.
9-125...........         9-147  ISO/CIE 11664-2 First   Withdrawn and
                                 edition 2022-08         replaced with
                                 Colorimetry--Part 2:    newer version.
                                 CIE standard
                                 illuminants.
9-128...........         9-148  ISO/CIE 11664-6 Second  Withdrawn and
                                 edition 2022-08         replaced with
                                 Colorimetry--Part 6:    newer version.
                                 CIEDE2000 Colour-
                                 difference formula.
9-143...........  ............  ISO 20696 First         Extent of
                                 edition 2018-06         recognition.
                                 Corrected version
                                 2019-12 Sterile
                                 urethral catheters
                                 for single use.
------------------------------------------------------------------------
                              M. Ophthalmic
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
11-294..........        11-399  ASTM F1357-23 Standard  Withdrawn and
                                 Specification for       replaced with
                                 Articulating Total      newer version.
                                 Wrist Implants.
------------------------------------------------------------------------

                          O. Physical Medicine
------------------------------------------------------------------------
16-165..........        16-234  ISO 7176-14 Third       Withdrawn and
                                 Edition 2022            replaced with
                                 Wheelchairs--Part 14    newer version.
                                 Power and control
                                 systems for
                                 electrically powered
                                 wheelchairs and
                                 scooters--Requirement
                                 s and test methods.
16-194..........        16-235  ISO 7176-25 Second      Withdrawn and
                                 Edition 2022            replaced with
                                 Wheelchairs--Part 25:   newer version.
                                 Lead-acid batteries
                                 and chargers for
                                 powered wheelchairs--
                                 Requirements and test
                                 methods.
16-201..........        16-236  ISO 7176-19 Third       Withdrawn and
                                 Edition 2022            replaced with
                                 Wheelchairs--Part 19:   newer version.
                                 Wheeled mobility
                                 devices for use as
                                 seats in motor
                                 vehicles.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
12-6............        12-350  IEC 60806 Edition 2.0   Withdrawn and
                                 2022-11 Determination   replaced with
                                 of the maximum          newer version.
                                 symmetrical radiation
                                 field of X-ray tube
                                 assemblies and X-ray
                                 source assemblies for
                                 medical diagnosis.
12-347..........  ............  IEC 60601-2-33 Edition  Transition
                                 4.0 2022-08 Medical     period
                                 electrical equipment--  extended.
                                 Part 2-33: Particular
                                 requirements for the
                                 basic safety and
                                 essential performance
                                 of magnetic resonance
                                 equipment for medical
                                 diagnosis.
12-329..........        12-351  IEC 60601-2-43 Edition  Withdrawn and
                                 3.0 2022-12 Medical     replaced with
                                 electrical equipment--  newer version.
                                 Part 2-43: Particular
                                 requirements for the
                                 basic safety and
                                 essential performance
                                 of X-ray equipment
                                 for interventional
                                 procedures.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-169..........        14-584  ASTM F2391-22 Standard  Withdrawn and
                                 Test Method for         replaced with
                                 Measuring Package and   newer version.
                                 Seal Integrity Using
                                 Helium as the Tracer
                                 Gas.
14-456..........        14-585  ISO/TS 16775 Second     Withdrawn and
                                 edition 2021-11         replaced with
                                 Packaging for           newer version.
                                 terminally sterilized
                                 medical devices--
                                 Guidance on the
                                 application of ISO
                                 11607-1 and ISO 11607-
                                 2.
14-575..........  ............  ASTM F1980-21 Standard  Transition
                                 Guide for Accelerated   period
                                 Aging of Sterile        extended.
                                 Barrier Systems for
                                 Medical Devices.
------------------------------------------------------------------------
                          S. Tissue Engineering
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

III. Listing of New Entries

    In table 2, FDA provides the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 060. These entries are of standards not
previously recognized by FDA.

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                     Reference No. and
   Recognition No.        Title of standard \1\             date
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-185................  Active implantable medical  ANSI/AAMI PC76:2021.
                        devices--Requirements and
                        test protocols for safety
                        of patients with
                        pacemakers and ICDs
                        exposed to magnetic
                        resonance imaging.
3-186................  Implants for surgery--      ISO 14708-2 Third
                        Active implantable          edition 2019-09.
                        medical devices--Part 2:
                        Cardiac pacemakers.
3-187................  Implants for surgery--      ISO 14708-6 Second
                        Active implantable          edition 2019-09.
                        medical devices--Part 6:
                        Particular requirements
                        for active implantable
                        medical devices intended
                        to treat tachyarrhythmia
                        (including implantable
                        defibrillators).

3-188................  Non-invasive                ISO 81060-3 First
                        sphygmomanometers--Part     edition 2022-12.
                        3: Clinical investigation
                        of continuous automated
                        measurement type.
------------------------------------------------------------------------
                              D. Dental/ENT
------------------------------------------------------------------------
4-305................  Dentistry--Central suction  ISO 10637 Second
                        source equipment.           edition 2018-05.
4-306................  Dentistry--Compressed air   ISO 22052 First
                        source equipment.           edition 2020-06.
4-307................  Dentistry--General          ISO 13504 First
                        requirements for            edition 2012-07.
                        instruments and related
                        accessories used in
                        dental implant placement
                        and treatment.
4-308................  Implants for surgery--      ISO 14708-7 Second
                        Active implantable          edition 2019-12
                        medical devices--Part 7:    (Corrected version
                        Particular requirements     2020-05).
                        for cochlear and auditory
                        brainstem implant systems.
------------------------------------------------------------------------
                          E. General I (QS/RM)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                         F. General II (ES/EMC)
------------------------------------------------------------------------
19-49................  Medical electrical          IEC 60601-1 Edition
                        equipment--Part 1:          3.2 2020-08
                        General requirements for    CONSOLIDATED
                        basic safety and            VERSION.
                        essential performance.
------------------------------------------------------------------------
                                G. GH/GPS
------------------------------------------------------------------------
6-495................  Catheter systems for        ISO 20698 First
                        neuraxial application--     Edition 2018-07.
                        Sterile and single-use
                        catheters and accessories.
6-496................  Standard Test Method for    ASTM F739-20.
                        Permeation of Liquids and
                        Gases Through Protective
                        Clothing Materials Under
                        Conditions of Continuous
                        Contact.
------------------------------------------------------------------------
                                 H. IVD
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-604................  Standard Specification for  ASTM F2257-22.
                        Wrought Seamless or
                        Welded and Drawn
                        18Chromium-14Nickel-
                        2.5Molybdenum Stainless
                        Steel Small Diameter
                        Tubing for Surgical
                        Implants (UNS S31673).
------------------------------------------------------------------------
                            J. Nanotechnology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                           L. OB-Gyn/G/Urology
------------------------------------------------------------------------
9-149................  Medical electrical          IEC 60601-2-39
                        equipment--Part 2-39:       Edition 3.0 2018-04.
                        Particular requirements
                        for basic safety and
                        essential performance of
                        peritoneal dialysis
                        equipment.
------------------------------------------------------------------------

                              M. Ophthalmic
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-586...............  Sterilization of health     ISO 22441 First
                        care products--Low          edition 2022-08.
                        temperature vaporized
                        hydrogen peroxide--
                        Requirements for the
                        development, validation
                        and routine control of a
                        sterilization process for
                        medical devices.
14-587...............  Guidance on transferring    AAMI TIR104:2022.
                        health care products
                        between radiation
                        sterilization sources.
14-588...............  Compatibility of materials  AAMI TIR17:2017/
                        subjected to                (R)2020.
                        sterilization.
------------------------------------------------------------------------
                          S. Tissue Engineering
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

IV. List of Recognized Standards

    FDA maintains the current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has recognized by notice published in the
Federal Register or that FDA has decided to recognize but for which
recognition is pending (because a periodic notice has not yet appeared
in the Federal Register). FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
[email protected]. To be considered, such recommendations
should contain, at a minimum, the information available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.

    Dated: August 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16770 Filed 8-4-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 134 (Monday, July 14, 2014)]
[Rules and Regulations]
[Page 40644]
[FR Doc No: 2014-16333]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-1033]

Safety Zones; Annual Events Requiring Safety Zones in the Captain
of the Port Lake Michigan Zone--Start of the Chicago to Mackinac Race

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the safety zone on Lake Michigan
near Chicago, IL for the start of the Chicago to Mackinac Race. This
zone will be enforced on July 18, 2014, from 1:30 p.m. until 4 p.m.,
and on July 19, 2014, from 10 a.m. until 4:30 p.m. This action is
necessary and intended to ensure safety of life on navigable waters
during the start of the Chicago to Mackinac Race. During the
aforementioned periods, the Coast Guard will enforce restrictions upon,
and control movement of, vessels in the safety zone. No person or
vessel may enter the safety zone while it is being enforced without
permission of the Captain of the Port, Lake Michigan.

DATES: The regulations in 33 CFR 165.929 will be enforced for safety
zone (e)(45) in Sec.  165.929, Table 165.929, on July 18, 2014, from
1:30 p.m. until 4 p.m., and on July 19, 2014, from 10 a.m. until 4:30
p.m.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
document, call or email MST1 Joseph McCollum, Prevention Department,
Coast Guard Sector Lake Michigan, Milwaukee, WI at<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Start of
Chicago to Mackinac Race safety zone listed as item (e)(45) in Table
165.929 of 33 CFR 165.929. Section 165.929 lists many annual events
requiring safety zones in the Captain of the Port Lake Michigan zone.
This zone will encompass all waters of Lake Michigan in the vicinity of
the Navy Pier at Chicago IL, within a rectangle that is approximately
1500 by 900 yards. The rectangle is bounded by the coordinates
beginning at 41[deg]53'15.1'' N, 087[deg]35'25.8'' W; then south to
41[deg]52'48.7'' N, 087[deg]35'25.8'' W; then east to 41[deg]52'49.0''
N, 087[deg]34'26.0'' W; then north to 41[deg]53'15'' N, 087[deg]34'26''
W; then west, back to point of origin (NAD 83). This zone will be
enforced on July 18, 2014 from 1:30 p.m. until 4 p.m., and on July 19,
2014, from 10 a.m. until 4:30 p.m.
    All vessels must obtain permission from the Captain of the Port
Lake Michigan or the on-scene representative to enter, move within, or
exit a safety zone. Vessels and persons granted permission to enter the
safety zone must obey all lawful orders or directions of the Captain of
the Port Lake Michigan or a designated representative. Vessels that
wish to transit through the safety zone may request permission from the
Captain of the Port Lake Michigan. Requests must be made in advance and
approved by the Captain of the Port before transits will be authorized.
Approvals will be granted on a case by case basis.
    This document is issued under authority of 33 CFR 165.929, Safety
Zones; Annual events requiring safety zones in the Captain of the Port
Lake Michigan zone, and 5 U.S.C. 552(a). In addition to this
publication in the Federal Register, the Coast Guard will provide the
maritime community with advance notification of this event via
Broadcast Notice to Mariners or Local Notice to Mariners that the
regulation is in effect. The Captain of the Port, Lake Michigan, or her
on-scene representative may be contacted via Channel 16, VHF-FM.

    Dated: June 30, 2014.
A.B. Cocanour,
Captain, U.S. Coast Guard, Captain of the Port, Lake Michigan.
[FR Doc. 2014-16333 Filed 7-11-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 205 (Monday, October 24, 2011)]
[Notices]
[Page 65736]
[FR Doc No: 2011-27327]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Oncologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on December 7, 2011, from 8
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Yvette Waples, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, Fax: 301-847-
8533, e-mail<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), and
follow the prompts to the desired center or product area. Please call
the Information Line for up-to-date information on this meeting. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On December 7, 2011, during the morning session, the
committee will discuss new drug application (NDA) 202324, with the
proposed trade name Inlyta (axitinib) tablets, application submitted by
Pfizer, Inc. The proposed indication (use) for this product is for the
treatment of patients with advanced renal cell carcinoma (kidney
cancer).
    During the afternoon session, the committee will discuss new drug
application (NDA) 202799, with the established name peginesatide
injection, application submitted by Affymax, Inc. The proposed
indication (use) for this product is for the treatment of anemia
associated with chronic renal failure in adult patients on dialysis.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 22, 2011. Oral presentations from the public will be scheduled
between approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m.
Those individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
November 14, 2011. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by November 15,
2011.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Yvette Waples at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: October 18, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-27327 Filed 10-21-11; 8:45 am]
BILLING CODE 4160-01-P


	Ronnail Rawls

09/22/2006 07:57 AM

	To:	ADMB_HQ OAR@EPA

	cc:

	Subject:	EPA keep clean air standards<EMAIL_ADDRESS>

Betty Guthrie

Box 328

Athens, AL 35612-0328

September 22, 2006

Administrator Stephen L. Johnson

1200 Pennsylvania Ave., N.W.

Rm. 1101A

Washington, DC 20460

Dear Administrator Johnson:

Docket  ID No.  OAR-2001-0017

Dear Administrator Johnson:

EPA now proposes new air pollution standards that do not follow the

recommendations of its own air pollution health science experts and are

not consistent with the requirements of the Clean Air  Act.

Americans already suffer from air pollution.  You must  raise the

standards back to the levels  recommended by your own staff and experts.

Sincerely

Betty Champagne Guthrie

(406)-622-5545


[Federal Register: July 21, 2009 (Volume 74, Number 138)]
[Notices]
[Page 35876]
[DOCID:fr21jy09-65]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Risk Communication Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Risk Communication Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on August 13, 2009, from 8
a.m. to 5 p.m. and August 14, 2009, from 8 a.m. to 2 p.m.
    Location: National Transportation Safety Board (NTSB) Conference
Center, 429 L'Enfant Plaza SW., Washington, DC 20594 (at Metro's
L'Enfant Plaza station; parking is limited and public transportation is
recommended.)
    Contact Person: Lee L. Zwanziger, Office of the Commissioner,
Office of Policy, Planning and Preparedness, Office of Planning, Food
and Drug Administration, 5600 Fishers Lane, rm. 14-90, Rockville, MD
20857,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>or
FDA Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER>
in the Washington, DC area), code<PHONE_NUMBER>. Please call the
Information Line for up-to-date information on this meeting. A notice
in the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On August 13 and 14, 2009, the Committee will discuss FDA's
external research on, and internal assessment of, communications about
food safety problems. This discussion will address research on consumer
knowledge of food recalls and plans for how to monitor communication
effectiveness during the course of a recall. The purpose of the
discussion is to advise FDA on developing more effective communication
strategies. Also on August 14, 2009, the RCAC will be briefed on the
work of the FDA Transparency Task Force.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm, click on the year 2009 and scroll down to the appropriate
advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
August 7, 2009. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on August 13th and 10:30 to
11:30 a.m. on August 14th. Those desiring to make formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before August 6, 2009. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by August 7,
2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Lee L. Zwanziger at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.

    Dated: July 10, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-17222 Filed 7-20-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Notices]
[Pages 42732-42735]
[FR Doc No: 2018-18167]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83882; File No. SR-FINRA-2018-032]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of a Proposed Rule Change To Amend
FINRA Rule 6710 To Modify the Dissemination Protocols for Agency Debt
Securities

August 17, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 16, 2018, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by FINRA. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

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

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

    FINRA is proposing to amend FINRA Rule 6710 to modify the
dissemination protocols with respect to Agency Debt Securities.
    The text of the proposed rule change is available on FINRA's
website at http://www.finra.org, at the principal office of FINRA and
at the Commission's Public Reference Room.

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

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

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

1. Purpose
    FINRA requires members to report to the Trade Reporting and
Compliance Engine (``TRACE'') transactions in TRACE-Eligible
Securities,\3\ including securities that meet the definition of
``Agency Debt Security.'' \4\ FINRA disseminates transaction
information on Agency Debt Securities and displays either the actual
size (volume) of the transaction or a capped amount, depending on
whether the security is rated as Investment Grade,\5\ Non-Investment
Grade,\6\ or is unrated. For transactions in Agency Debt Securities
that are either Investment Grade or unrated, FINRA disseminates the
actual size of the trade for transactions less than or equal to $5
million in par value traded, thus providing actual transaction size up
to $5 million, and disseminates ``$5MM+'' for trades exceeding $5
million in par value traded.\7\ For transactions in Agency Debt
Securities that are Non-Investment Grade, FINRA disseminates the actual
size of the trade for transactions less than or equal to $1 million in
par value, and disseminates ``1MM+'' for trades exceeding $1 million in
par value traded.\8\
---------------------------------------------------------------------------

    \3\ Rule 6710 generally defines a ``TRACE-Eligible Security''
as: A debt security that is United States (``U.S.'') dollar-
denominated and is: (1) Issued by a U.S. or foreign private issuer,
and, if a ``restricted security'' as defined in Securities Act Rule
144(a)(3), sold pursuant to Securities Act Rule 144A; (2) issued or
guaranteed by an Agency as defined in Rule 6710(k) or a Government-
Sponsored Enterprise as defined in Rule 6710(n); or (3) a U.S.
Treasury Security as defined in Rule 6710(p). ``TRACE-Eligible
Security'' does not include a debt security that is issued by a
foreign sovereign or a Money Market Instrument as defined in Rule
6710(o).
    \4\ ``Agency Debt Security'' generally includes a debt security
(i) issued or guaranteed by an Agency as defined in Rule 6710(k);
(ii) issued or guaranteed by a Government-Sponsored Enterprise
(``GSE'') as defined in Rule 6710(n); or (iii) issued by a trust or
other entity that was established or sponsored by a GSE for the
purpose of issuing debt securities, where such enterprise provides
collateral to the trust or other entity or retains a material net
economic interest in the reference tranches associated with the
securities issued by the trust or other entity. Rule 6710(n)
provides that ``Government-Sponsored Enterprise'' has the same
meaning as defined in 2 U.S.C. 622(8).
    \5\ Rule 6710 provides that ``Investment Grade'' means ``a
TRACE-Eligible Security that, if rated by only one nationally
recognized statistical rating organization (``NRSRO''), is rated in
one of the four highest generic rating categories; or if rated by
more than one NRSRO, is rated in one of the four highest generic
rating categories by all or a majority of such NRSROs; provided that
if the NRSROs assign ratings that are evenly divided between (i) the
four highest generic ratings and (ii) ratings lower than the four
highest generic ratings, FINRA will classify the TRACE-Eligible
Security as Non-Investment Grade for purposes of TRACE. If a TRACE-
Eligible Security is unrated, for purposes of TRACE, FINRA may
classify the TRACE-Eligible Security as an Investment Grade
security. FINRA will classify an unrated Agency Debt Security as
defined in [Rule 6710(l)] as an Investment Grade security for
purposes of the dissemination of transaction volume.'' See FINRA
Rule 6710(h).
    \6\ Rule 6710 provides that ``Non-Investment Grade'' means ``a
TRACE-Eligible Security that, if rated by only one NRSRO, is rated
lower than one of the four highest generic rating categories; or if
rated by more than one NRSRO, is rated lower than one of the four
highest generic rating categories by all or a majority of such
NRSROs. Except as provided in paragraph (h), if a TRACE-Eligible
Security is unrated, FINRA may classify the TRACE-Eligible Security
as a Non-Investment Grade security.'' See FINRA Rule 6710(i).
    \7\ See Securities Exchange Act Release No. 59733 (April 8,
2009), 74 FR 17709 (April 16, 2009) (Notice of Filing of File No.
SR-FINRA-2009-010).
    \8\ See supra note 7.
---------------------------------------------------------------------------

    FINRA is proposing to apply a $5 million dissemination cap to all
Agency Debt Securities, regardless of the rating assigned to the
security. When adopting the original dissemination caps for Agency Debt
Securities, FINRA believed that unrated Agency Debt Securities should
default to the $5 million dissemination cap due to factors such as that
they trade more consistently with Investment Grade securities that are
subject to the $5 million dissemination cap. While Non-Investment Grade
Agency Debt Securities have been disseminated with the $1 million
dissemination cap, FINRA is not aware of the existence of any Non-
Investment Grade Agency Debt Securities other than credit risk transfer
securities (``CRTs''), a type of Agency Debt Security issued by Fannie
Mae (``Fannie'') and Freddie Mac (``Freddie''). Based on experience
gained with CRTs and in consultation with Fannie and Freddie, FINRA

believes that it is appropriate to disseminate Non-Investment Grade
CRTs with the $5 million dissemination cap. Because CRTs are the only
type of Agency Debt Security rated less than Investment Grade, FINRA is
proposing to simplify the dissemination structure by applying the $5
million dissemination cap to all Agency Debt Securities irrespective of
rating.
    FINRA notes that transactions in the vast majority of securities
issued by Fannie and Freddie are disseminated with the actual size of
the trade (uncapped), and, of those that are capped, the vast majority
are disseminated with the $5 million cap: 94.4% of all transactions in
direct obligations issued by Fannie and Freddie, including CRTs,
currently are disseminated with the actual size of the trade. Of the
remaining 5.6% that are capped (both at $1 million and $5 million), 95%
currently are disseminated with the $5 million cap. Thus, FINRA
believes that the proposed modification to apply the $5 million
dissemination cap to all Agency Debt Securities uniformly will have a
minimal impact, while simplifying the dissemination structure and
providing additional transparency in Agency Debt Securities.
    If the Commission approves the proposed rule change, FINRA will
announce the effective date of the proposed rule change in a Regulatory
Notice to be published no later than 60 days following Commission
approval. The effective date will be no later than 120 days following
publication of the Regulatory Notice announcing Commission approval.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\9\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. The proposed rule change would benefit investors in
that it would simplify the dissemination structure by creating a
uniform dissemination protocol for all Agency Debt Securities, and
would increase transparency for transactions in Non-Investment Grade
Agency Debt Securities over $1 million. Additionally, the proposed rule
change would have a minimal impact as the vast majority of capped
transactions in Agency Debt Securities are already disseminated with
the $5 million cap.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.
Economic Impact Assessment
    FINRA has undertaken an economic impact assessment, as set forth
below, to analyze the potential economic impacts, including anticipated
costs, benefits, and distributional and competitive effects, relative
to the current baseline, and the alternatives FINRA considered in
assessing how to best meet its regulatory objectives.
Economic Baseline
    As of December 31, 2017, there were 35 Investment Grade, 9 Non-
Investment Grade, and 172 unrated CRT classes (based on TRACE data).
FINRA notes that certain CRTs are currently the only type of Agency
Debt Security with a Non-Investment Grade rating. The outstanding
amount of these issues are $770 million, $350 million and $2,877
million for Investment Grade, Non-Investment Grade and unrated issues
respectively. Table 1 presents the number of trades reported to TRACE
and nominal trade value of CRT CUSIPs by rating for the calendar year
beginning January 1, 2017.\10\
---------------------------------------------------------------------------

    \10\ Each CRT deal utilizes a senior/subordinate structure in
which credit protection is provided to the senior class by the
subordinate classes in priority order. The senior class and
subordinate tranches, while part of the same CRT issuance, are
separate securities and each are assigned a unique CUSIP. In
addition, each CRT class can be further tranched to provide
additional optionality for investors' needs. As such, each CRT class
is associated with multiple unique CUSIPs. We note that only the
CUSIP associated with the senior tranche contributes to the amount
of debt outstanding for a given CRT class.

                                                     Table 1
----------------------------------------------------------------------------------------------------------------
                                                              Trades                        Trade value
                                                 ---------------------------------------------------------------
                      Grade                                                           Dollars
                                                      Number          Percent       (millions)        Percent
----------------------------------------------------------------------------------------------------------------
Non-Investment..................................           1,950            13.6         8,800.9            13.6
Investment......................................           1,988            13.8         8,880.1            13.7
Unrated.........................................          10,423            72.6        47,077.7            72.7
----------------------------------------------------------------------------------------------------------------

    Under the existing dissemination protocols, Agency Debt Securities
that are unrated or rated Investment Grade are disseminated with a $5
million dissemination cap, where trades over $5 million are displayed
as ``5MM+.'' Non-Investment Grade Agency Debt Securities are
disseminated with a $1 million dissemination cap, where trades over $1
million are displayed as ``1MM+.'' Table 2 presents the number and
percent of trades and nominal trade value disseminated with actual
trade sizes or displayed with ``5MM+'' for Investment Grade or unrated
CRT CUSIPs for calendar year 2017. These statistics include all trades
reported to TRACE during the period, and thus would include two trade
reports for interdealer trades and one trade report for dealer to
customer trades (two-sided trade data).\11\
---------------------------------------------------------------------------

    \11\ For calendar year 2017, there were 11,341 trades reported
to TRACE, that include only one trade report for interdealer trades
and one trade report for dealer to customer trades (one-sided trade
data), in Investment Grade and unrated CRT CUSIPs, of which 20.8%
were displayed as ``5MM+.''

                                                     Table 2
----------------------------------------------------------------------------------------------------------------
                                                                              Trades
                                                 ---------------------------------------------------------------
                      Grade                                    <=$5M                           >$5M
                                                 ---------------------------------------------------------------
                                                      Number          Percent         Number          Percent
----------------------------------------------------------------------------------------------------------------
Investment......................................           1,524            76.7             464            23.3
Unrated.........................................           8,435            80.9           1,988            19.1
----------------------------------------------------------------------------------------------------------------

                                                                            Trade value
                                                 ---------------------------------------------------------------
                                                               <=$5M                           >$5M
                                                 ---------------------------------------------------------------
                                                      Dollars                         Dollars
                                                    (millions)        Percent       (millions)        Percent
----------------------------------------------------------------------------------------------------------------
Investment......................................         2,591.5            29.2         6,288.6            28.2
Unrated.........................................        22,390.9            47.6        24,686.7            46.6
----------------------------------------------------------------------------------------------------------------

    Table 3 presents the number and percent of trades and nominal trade
value disseminated with actual trade sizes or displayed with ``1MM+''
for Non-Investment Grade CRT CUSIPs for calendar year 2017.\12\
---------------------------------------------------------------------------

    \12\ For calendar year 2017, there were 1,712 trades reported to
TRACE, that include only one trade report for interdealer trades and
one trade report for dealer to customer trades (one-sided trade
data), in Non-Investment Grade CUSIPs, of which 88.3% were displayed
as ``1MM+.''

                                                     Table 3
----------------------------------------------------------------------------------------------------------------
                                                                              Trades
                                                 ---------------------------------------------------------------
                      Grade                                    <=$1M                           >$1M
                                                 ---------------------------------------------------------------
                                                      Number          Percent         Number          Percent
----------------------------------------------------------------------------------------------------------------
Non-Investment..................................             222            11.4           1,728            88.6
----------------------------------------------------------------------------------------------------------------

                                                                            Trade value
                                                 ---------------------------------------------------------------
                                                               <=$1M                           >$1M
                                                 ---------------------------------------------------------------
                                                      Dollars                         Dollars
                                                    (millions)        Percent       (millions)        Percent
----------------------------------------------------------------------------------------------------------------
Non-Investment..................................           139.7             1.6         8,661.2            98.4
----------------------------------------------------------------------------------------------------------------

Economic Impact
    Based on transactions during calendar year 2017, this proposal
would have led to dissemination of additional trade size information
for 1,112 trades in 82 CRT CUSIPs than disseminated under the current
protocols. This increased transparency could have impacts on investors,
market makers and issuers. Markets participants, especially uninformed
investors, generally anticipate that they benefit from greater price
transparency because, in the presence of this information, they are
more likely to gain more timely information about the current price of
an asset. Knowing this, they may be more willing to commit capital.\13\
---------------------------------------------------------------------------

    \13\ For instance, one study that examined corporate bond
transactions in TRACE from January 2003 through January 2005 found
that ``[c]osts are lower for bonds with transparent trade prices,
and they drop when the TRACE system starts to publicly disseminate
their prices. The results suggest that public traders benefit
significantly from price transparency.'' For additional details, see
Amy K. Edwards, Lawrence E. Harris, and Michael S. Piwowar,
Corporate Bond Market Transaction Costs and Transparency, Journal of
Finance 62, No. 3, 1421-1451 (2007).
---------------------------------------------------------------------------

    At the same time, FINRA understands that some firms believe that
transparency about the size of larger trades impedes their ability to
commit capital and hence may have a negative impact on liquidity.
Increasing transparency may increase the amount of information
available to uninformed investors on transaction size and price. This
may reduce the informed investors' relative advantage by decreasing the
bid-ask spread earned by an informed investor or increasing the bid-ask
spread paid by an informed investor. Furthermore, firms may be less
willing to trade as principal and hold these securities in inventory,
leading to wider spreads or less depth, if they fear that investors may
identify the firms' inventory position.\14\ In addition, existing
institutional investors that prefer trading in large sizes or at the
current level of transparency in Non-Investment Grade CRTs may
substitute trading in other asset classes, if the investors fear others
may identify their holdings. The consensus of the academic literature
studying the impact of transparency in a variety of settings in U.S.
fixed income markets is that greater transparency is associated with
lower costs to end customers and positive to neutral impacts on market
liquidity.\15\ In addition, FINRA has discussed the proposed rule
change with Fannie and Freddie, both of which support the application
of the $5 million dissemination cap to all CRTs.
---------------------------------------------------------------------------

    \14\ See supra note 13.
    \15\ See supra note 13.
---------------------------------------------------------------------------

Alternatives
    No alternatives are under consideration.

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

    Written comments were neither solicited nor received.

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

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-FINRA-2018-032 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2018-032. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of FINRA. All comments received
will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-FINRA-2018-032, and should be submitted
on or before September 13, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-18167 Filed 8-22-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)]
[Rules and Regulations]
[Pages 42034-42036]
[FR Doc No: 2018-17935]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

[EPA-R04-OAR-2017-0390; FRL-9982-70--Region 4]

Air Plan Approval and Air Quality Designation; KY; Redesignation
of the Kentucky Portion of the Louisville Unclassifiable Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: On May 4, 2018, the Commonwealth of Kentucky, through the
Kentucky Energy and Environment Cabinet, Division for Air Quality
(KDAQ), submitted a request for the Environmental Protection Agency
(EPA) to redesignate the portion of Kentucky that is within the bi-
state Louisville, KY-IN fine particulate matter (PM2.5)
unclassifiable area (hereinafter referred to as the ``bi-state
Louisville Area'' or ``Area'') to unclassifiable/attainment for the
2012 primary annual PM2.5 national ambient air quality
standard (NAAQS). The bi-state Louisville Area consists of Jefferson
County and a portion of Bullitt County in Kentucky, as well as Clark
and Floyd Counties in Indiana. EPA is approving the State's request and
redesignating the Area to unclassifiable/attainment for the 2012
primary annual PM2.5 NAAQS based upon valid, quality-
assured, and certified ambient air monitoring data showing that the
PM2.5 monitors in the bi-state Louisville Area are in
compliance with the 2012 primary annual PM2.5 NAAQS.

DATES: This rule will be effective September 19, 2018.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2017-0390. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
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 either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Madolyn Sanchez, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. Ms. Sanchez can be reached by telephone at<PHONE_NUMBER>
or via electronic mail at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On December 14, 2012, EPA revised the primary annual NAAQS for
PM2.5 at a level of 12 micrograms per cubic meter ([micro]g/
m\3\), based on a 3-year average of annual mean PM2.5
concentrations. See 78 FR 3085 (January 15, 2013). EPA established the
standards based on significant evidence and numerous health studies
demonstrating that serious health effects are associated with exposures
to particulate matter.
    The process for designating areas following promulgation of a new
or revised NAAQS is contained in section

107(d)(1) of the CAA. On December 18, 2014, EPA designated the majority
of areas across the country as nonattainment, unclassifiable/
attainment, or unclassifiable\1\ for the 2012 PM2.5 NAAQS
based upon air quality monitoring data from monitors for calendar years
2011-2013. See 80 FR 2206 (January 15, 2015). EPA's January 15, 2015,
rulemaking notice also described a process by which EPA would evaluate
any complete, quality-assured, certified air quality monitoring data
from 2014 that a state submitted for consideration before February 27,
2015. EPA stated that it would evaluate whether, with the inclusion of
certified 2014 data, the 3-year design value for 2012-2014 suggests
that a change in the initial designation would be appropriate for an
area. If EPA agreed that a change in the initial designation would be
appropriate, EPA would withdraw the designation announced in the
January 15, 2015, notice for such area before the effective date and
issue another designation reflecting the inclusion of 2014 data.
---------------------------------------------------------------------------

    \1\ For the initial PM area designations in 2014 (for the 2012
annual PM2.5 NAAQS), EPA used a designation category of
``unclassifiable/attainment'' for areas that had monitors showing
attainment of the standard and were not contributing to nearby
violations and for areas that did not have monitors but for which
EPA had reason to believe were likely attaining the standard and not
contributing to nearby violations. EPA used the category
``unclassifiable'' for areas in which EPA could not determine, based
upon available information, whether or not the NAAQS was being met
and/or EPA had not determined the area to be contributing to nearby
violations. EPA reserves the ``attainment'' category for when EPA
redesignates a nonattainment area that has attained the relevant
NAAQS and has an approved maintenance plan.
---------------------------------------------------------------------------

    In a follow-up designation action published on April 7, 2015 (80 FR
18535), EPA designated five areas as unclassifiable/attainment in
Georgia, including two neighboring counties in the bordering states of
Alabama and South Carolina, that were initially deferred in EPA's
January 15, 2015, rulemaking. In the same action, EPA changed the
designations for one area in Ohio, two areas in Pennsylvania, and one
bi-state area with portions in Kentucky and Ohio from nonattainment to
unclassifiable/attainment. The bi-state Louisville Area was changed
from nonattainment to unclassifiable.
    On May 4, 2018, Kentucky submitted a request for EPA to redesignate
the bi-state Louisville Area to unclassifiable/attainment for the 2012
primary annual PM2.5 NAAQS now that there is sufficient data
to determine that the Area is in attainment. In a notice of proposed
rulemaking (NPRM) published on May 30, 2018 (83 FR 24714), EPA proposed
to approve the State's request to redesignate the Kentucky portion of
the bi-state Louisville Area to unclassifiable/attainment for the 2012
primary annual PM2.5 NAAQS. The details of Kentucky's
submittal and the rationale for EPA's actions are further explained in
the NPRM. EPA did not receive any adverse comments on the proposed
action.

II. Final Action

    EPA is approving Kentucky's redesignation request and redesignating
the Kentucky portion of the bi-state Louisville Area from
unclassifiable to unclassifiable/attainment for the 2012 primary annual
PM2.5 NAAQS.

III. Statutory and Executive Order Reviews

    Under the CAA, redesignation of an area to unclassifiable/
attainment is an action that affects the status of a geographical area
and does not impose any additional regulatory requirements on sources
beyond those imposed by state law. A redesignation to unclassifiable/
attainment does not in and of itself create any new requirements.
Accordingly, this action merely redesignates an area to unclassifiable/
attainment and does not impose additional requirements. 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);
     is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because redesignations are exempted under
Executive Order 12866;
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (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 those requirements would be inconsistent
with the CAA; and
     will not have disproportionate human health or
environmental effects under Executive Order 12898 (59 FR 7629, February
16, 1994).
    This final redesignation action is not approved to apply to any
Indian reservation land or in any other area where 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), nor will it
impose substantial direct costs on tribal governments or preempt tribal
law.
    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. 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 October 19, 2018. 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 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: August 8, 2018.
Onis ``Trey'' Glenn, III
Regional Administrator, Region 4.

    40 CFR part 81 is amended as follows:

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
1. The authority citation for part 81 continues to read as follows:

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

0
2. In Sec.  81.318, the table entitled ``Kentucky-2012 Annual
PM2.5 NAAQS'' is amended under the heading ``Louisville, KY-
IN:'' by revising the entries for ``Bullitt County (part)'' and
``Jefferson County'' to read as follows:

Sec.  81.318  Kentucky.

* * * * *

                                        Kentucky--2012 Annual PM2.5 NAAQS
                                                    [Primary]
----------------------------------------------------------------------------------------------------------------
                                                     Designation                          Classification
        Designated area \1\        -----------------------------------------------------------------------------
                                           Date \2\                 Type             Date \2\          Type
----------------------------------------------------------------------------------------------------------------
Louisville, KY-IN:
    Bullitt County (part).........  August 20, 2018......  Unclassifiable/
                                                            Attainment..
        2010 Census tracts:
         201.01, 201.02, 201.03,
         202.01, 202.02, 203, 204,
         205, 206.01, 206.02,
         207.01, 207.02, 208,
         211.01 and 211.02.
    Jefferson County..............  August 20, 2018......  Unclassifiable/
                                                            Attainment..

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Includes areas of Indian country located in each county or area, except as otherwise specified.
\2\ This date is April 15, 2015, unless otherwise noted.

* * * * *
[FR Doc. 2018-17935 Filed 8-17-18; 8:45 am]
 BILLING CODE 6560-50-P