[Federal Register Volume 87, Number 156 (Monday, August 15, 2022)]
[Notices]
[Pages 50079-50085]
[FR Doc No: 2022-17474]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2022-0132; FRL-9411-06-OCSPP]

Certain New Chemicals; Receipt and Status Information for July
2022

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA),
as amended by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, to make information publicly available and to publish
information in the Federal Register pertaining to submissions under
TSCA section 5, including notice of receipt of a Premanufacture notice
(PMN), Significant New Use Notice (SNUN) or Microbial Commercial
Activity Notice (MCAN), including an amended notice or test
information; an exemption application (Biotech exemption); an
application for a test marketing exemption (TME), both pending and/or
concluded; a notice of commencement (NOC) of manufacture (including
import) for new chemical substances; and a periodic status report on
new chemical substances that are currently under EPA review or have
recently concluded review. This document covers the period from 7/1/
2022 to 7/31/2022.

DATES: Comments identified by the specific case number provided in this
document must be received on or before September 14, 2022.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2022-0132, and the specific case number for the
chemical substance related to your comment, through the Federal
eRulemaking Portal at https://www.regulations.gov. Follow the online
instructions for submitting comments. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Additional instructions on commenting and visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim
Rahai, Project Management and Operations Division (7407M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202)

564-8593; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    This action provides information that is directed to the public in
general.

B. What action is the Agency taking?

    This document provides the receipt and status reports for the
period from 7/1/2022 to 07/31/2022. The Agency is providing notice of
receipt of PMNs, SNUNs and MCANs (including amended notices and test
information); an exemption application under 40 CFR part 725 (Biotech
exemption); TMEs, both pending and/or concluded; NOCs to manufacture a
new chemical substance; and a periodic status report on new chemical
substances that are currently under EPA review or have recently
concluded review.
    EPA is also providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.

C. What is the Agency's authority for taking this action?

    Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et
seq., a chemical substance may be either an ``existing'' chemical
substance or a ``new'' chemical substance. Any chemical substance that
is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory)
is classified as a ``new chemical substance,'' while a chemical
substance that is listed on the TSCA Inventory is classified as an
``existing chemical substance.'' (See TSCA section 3(11).) For more
information about the TSCA Inventory please go to: https://www.epa.gov/tsca-inventory.
    Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN or SNUN, as appropriate,
before initiating the activity. EPA will review the notice, make a risk
determination on the chemical substance or significant new use, and
take appropriate action as described in TSCA section 5(a)(3).
    TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture or
process a new chemical substance, or a chemical substance subject to a
significant new use rule (SNUR) issued under TSCA section 5(a)(2), for
``test marketing'' purposes, upon a showing that the manufacture,
processing, distribution in commerce, use, and disposal of the chemical
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: https://www.epa.gov/oppt/newchems.
    Under TSCA sections 5 and 8 and EPA regulations, EPA is required to
publish in the Federal Register certain information, including notice
of receipt of a PMN/SNUN/MCAN (including amended notices and test
information); an exemption application under 40 CFR part 725 (biotech
exemption); an application for a TME, both pending and concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on the new chemical substances that are currently under EPA review or
have recently concluded review.

D. Does this action have any incremental economic impacts or paperwork
burdens?

    No.

E. What should I consider as I prepare my comments for EPA?

    1. Submitting confidential business information (CBI). Do not
submit CBI information to EPA through regulations.gov or email. Clearly
mark the part or all of the information that you claim to be CBI. For
CBI information in a disk or CD-ROM that you mail to EPA, mark the
outside of the disk or CD-ROM as CBI and then identify electronically
within the disk or CD-ROM the specific information that is claimed as
CBI. In addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Status Reports

    In the past, EPA has published individual notices reflecting the
status of TSCA section 5 filings received, pending or concluded. In
1995, the Agency modified its approach and streamlined the information
published in the Federal Register after providing notice of such
changes to the public and an opportunity to comment (See the Federal
Register of May 12, 1995, (60 FR 25798) (FRL-4942-7). Since the passage
of the Lautenberg amendments to TSCA in 2016, public interest in
information on the status of section 5 cases under EPA review and, in
particular, the final determination of such cases, has increased. In an
effort to be responsive to the regulated community, the users of this
information, and the general public, to comply with the requirements of
TSCA, to conserve EPA resources and to streamline the process and make
it more timely, EPA is providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.

III. Receipt Reports

    For the PMN/SNUN/MCANs that have passed an initial screening by EPA
during this period, Table I provides the following information (to the
extent that such information is not subject to a CBI claim) on the
notices screened by EPA during this period: The EPA case number
assigned to the notice that indicates whether the submission is an
initial submission, or an amendment, a notation of which version was
received, the date the notice was received by EPA, the submitting
manufacturer (i.e., domestic producer or importer), the potential uses
identified by the manufacturer in the notice, and the chemical
substance identity.
    As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G)

indicates that this information in the table is generic information
because the specific information provided by the submitter was claimed
as CBI. Submissions which are initial submissions will not have a
letter following the case number. Submissions which are amendments to
previous submissions will have a case number followed by the letter
``A'' (e.g. P-18-1234A). The version column designates submissions in
sequence as ``1'', ``2'', ``3'', etc. Note that in some cases, an
initial submission is not numbered as version 1; this is because
earlier version(s) were rejected as incomplete or invalid submissions.
Note also that future versions of the following tables may adjust
slightly as the Agency works to automate population of the data in the
tables.

                                              Table I--PMN/SNUN/MCANs Approved * From 7/1/2022 to 7/31/2022
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               Case No.                   Version     Received date         Manufacturer                   Use                   Chemical substance
--------------------------------------------------------------------------------------------------------------------------------------------------------
P-19-0160A............................            6      07/21/2022  CBI......................  (S) Component of a UV      (G) Alkanesulfonic acid, 2-
                                                                                curable printing ink.      [(2-aminoethyl)heteroatom-
                                                                                substituted]-, sodium salt
                                                                                (1:1), polymer with alpha-
                                                                                [2,2-
                                                                                bis(hydroxymethyl)butyl]-
                                                                                omega-methoxypoly(oxy-1,2-
                                                                                ethanediyl) and 1,1'-
                                                                                methylenebis[4-
                                                                                isocyanatocyclohexane],
                                                                                acrylic acid-
                                                                                dipenthaerythritol reaction
                                                                                products- and polypropylene
                                                                                glycol ether with
                                                                                pentaerythritol (4:1)
                                                                                triacrylate-blocked.
P-20-0108A............................            5      07/06/2022  CBI......................  (G) Film-forming polymer.  (G) Alkanoic acid, compds.
                                                                                with diphenolmethane
                                                                                derivative-N1,N1-dialkyl-1,3-
                                                                                alkanediamine-epiclorohydrin-
                                                                                2-cyclic ester homopolymer
                                                                                with dialkylene glycol (2:1)
                                                                                polymer-dialkanolamine
                                                                                reaction products.
P-20-0108A............................            6      07/15/2022  CBI......................  (G) Film-forming polymer.  (G) Alkanoic acid, compds.
                                                                                with diphenolmethane
                                                                                derivative-N1,N1-dialkyl-1,3-
                                                                                alkanediamine-epiclorohydrin-
                                                                                2-cyclic ester homopolymer
                                                                                with dialkylene glycol (2:1)
                                                                                polymer-dialkanolamine
                                                                                reaction products.
P-21-0011A............................            4      07/22/2022  CBI......................  (S) Crosslinking agent     (G) Hexane, 1,6-diisocyanato-
                                                                                for inks and coatings.     , homopolymer, alkyl epoxy
                                                                                ether- and polyethylene
                                                                                glycol mono-Me ether-
                                                                                blocked, reaction products
                                                                                with propylenimine.
P-21-0098A............................            5      07/06/2022  Hubergroup...............  (S) Co-initiator for the   (G) Poly(oxy-1,2-ethanediyl),
                                                                                curing of UV printing      alpha-hydro-omega-[2(or 3)-
                                                                                inks.                      [[substituted
                                                                                benzoyl]oxy]hydroxypropoxyl]-
                                                                                , alpha, alpha'', alpha'' -
                                                                                ether with 2-ethyl-2-
                                                                                (hydroxymethyl)-1,3-
                                                                                propanediol (3:1).
P-21-0174A............................            2      07/06/2022  Marubeni America           (G) Raw material for       (G) Carbonic acid, ester,
                                                                      Corporation.               polyurethane.              polymer with alkanediol
                                                                                (C=4,5).
P-22-0002.............................            3      07/21/2022  Materion Advanced          (G) This product is used   (G) Metal Oxide Chloride.
                                                                      Chemicals.                 for the manufacturing of
                                                                                electronic devices.
P-22-0040A............................            2      07/15/2022  Natron Energy............  (G) Component used in      (S) Manganate(4-),
                                                                                manufacture of high        hexakis(cyano-.kappa.C)-,
                                                                                performance batteries.     manganese (2+) sodium, (OC-6-
                                                                                11)-.
P-22-0041A............................            2      07/15/2022  Natron Energy............  (G) A component used in    (S) Ferrate (-4),
                                                                                the manufacture of         hexakis(cyano-.kappa.C)-,
                                                                                batteries.                 iron(3+) manganese(2+)
                                                                                sodium, (OC-6-11)-.
P-22-0069A............................            2      07/25/2022  CBI......................  (G) Component in battery.  (G) fluoroheteroacid, metal
                                                                                salt.
P-22-0071A............................            3      07/13/2022  Lamberti USA Inc.........  (G) Industrial Surfactant  (S) D-Glucopyranose,
                                                                                oligomeric, maleates, C9-11-
                                                                                alkyl glycosides,
                                                                                sulfonated, potassium salts.
P-22-0072A............................            3      07/13/2022  Lamberti USA Inc.........  (G) Industrial Surfactant  (S) D-Glucopyranose,
                                                                                oligomeric, maleates, decyl
                                                                                octyl glycosides,
                                                                                sulfonated, potassium salts.
P-22-0073A............................            3      07/13/2022  Lamberti USA Inc.........  (G) Industrial Surfactant  (S) D-Glucopyranose,
                                                                                oligomeric, maleates, C10-16-
                                                                                alkyl glycosides,
                                                                                sulfonated, potassium salts.
P-22-0087A............................            2      06/29/2022  Hubergroup...............  (S) Binder for energy-     (S) Fatty acids, C18-unsatd.,
                                                                                curing printing inks.      dimers, polymers with
                                                                                acrylic acid, bisphenol A,
                                                                                epichlorohydrin, oleic acid,
                                                                                2,2'-
                                                                                [oxybis(methylene)]bis[2-
                                                                                ethyl-1,3-propanediol] and
                                                                                phthalic anhydride.

P-22-0087A............................            3      07/06/2022  Hubergroup...............  (S) Binder for energy-     (S) Fatty acids, C18-unsatd.,
                                                                                curing printing inks.      dimers, polymers with
                                                                                acrylic acid, bisphenol A,
                                                                                epichlorohydrin, oleic acid,
                                                                                2,2'-
                                                                                [oxybis(methylene)]bis[2-
                                                                                ethyl-1,3-propanediol] and
                                                                                phthalic anhydride.
P-22-0088A............................            2      06/29/2022  Hubergroup...............  (S) Binder for energy-     (S) Fatty acids, C18-unsatd.,
                                                                                curing printing inks.      dimers, polymers with
                                                                                acrylic acid, bisphenol A,
                                                                                epichlorohydrin, oleic acid,
                                                                                pentaerythritol and phthalic
                                                                                anhydride.
P-22-0088A............................            3      07/06/2022  Hubergroup...............  (S) Binder for energy-     (S) Fatty acids, C18-unsatd.,
                                                                                curing printing inks.      dimers, polymers with
                                                                                acrylic acid, bisphenol A,
                                                                                epichlorohydrin, oleic acid,
                                                                                pentaerythritol and phthalic
                                                                                anhydride.
P-22-0118A............................            4      06/29/2022  Elantas PDG, Inc.........  (S) RV9054 is an           (S) Hexanedioic acid, polymer
                                                                                unsaturated polyester      with 1,2,3-propanetriol and
                                                                                resin used as a diluent    1,3,5-tris(2-hydroxyethyl)-
                                                                                in a finished product.     1,3,5-triazine-
                                                                                2,4,6(1H,3H,5H)-trione, 3-
                                                                                methyl-3-buten-1-yl ester.
P-22-0125A............................            3      06/30/2022  CBI......................  (G) corrosion inhibitor..  (G) Isononanoylamidocaproic
                                                                                Acid.
P-22-0130.............................            2      07/08/2022  Integrity Bio-Chemical,    (S) Surfactant--surface    (S) Maltodextrin, octanoate.
                                                                      LLC.                       tension reducing agent
                                                                                for use in production
                                                                                enhancement in oil wells
                                                                                (industrial),
                                                                                Emulsifier, Surface
                                                                                reduction Household and
                                                                                industrial detergents,
                                                                                Wetting agent Personal
                                                                                care, Agriculture,
                                                                                Surfactants--as raw
                                                                                materials for use in the
                                                                                manufacture of
                                                                                industrial products and
                                                                                consumer and household
                                                                                products.
P-22-0131.............................            2      07/08/2022  Integrity Bio-Chemical,    (S) Surfactant--surface    (S) Maltodextrin,
                                                                      LLC.                       tension reducing agent     hexadecanoate.
                                                                                for use in production
                                                                                enhancement in oil wells
                                                                                (industrial),
                                                                                Emulsifier, Surface
                                                                                reduction Household and
                                                                                industrial detergents,
                                                                                Wetting agent Personal
                                                                                care, Agriculture,
                                                                                Surfactants--as raw
                                                                                materials for use in the
                                                                                manufacture of
                                                                                industrial products and
                                                                                consumer and household
                                                                                products.

P-22-0132.............................            2      07/08/2022  Integrity Bio-Chemical,    (S) Surfactant--surface    (S) Maltodextrin, decanoate.
                                                                      LLC.                       tension reducing agent
                                                                                for use in production
                                                                                enhancement in oil wells
                                                                                (industrial),
                                                                                Emulsifier, Surface
                                                                                reduction Household and
                                                                                industrial detergents,
                                                                                Wetting agent Personal
                                                                                care, Agriculture,
                                                                                Surfactants--as raw
                                                                                materials for use in the
                                                                                manufacture of
                                                                                industrial products and
                                                                                consumer and household
                                                                                products.
P-22-0133.............................            2      07/08/2022  Integrity Bio-Chemical,    (S) Surfactant--surface    (S) Maltodextrin,
                                                                      LLC.                       tension reducing agent     octadecanoate.
                                                                                for use in production
                                                                                enhancement in oil wells
                                                                                (industrial),
                                                                                Emulsifier, Surface
                                                                                reduction Household and
                                                                                industrial detergents,
                                                                                Wetting agent Personal
                                                                                care, Agriculture,
                                                                                Surfactants--as raw
                                                                                materials for use in the
                                                                                manufacture of
                                                                                industrial products and
                                                                                consumer and household
                                                                                products products (e.g.,
                                                                                cleaners).
P-22-0134.............................            2      07/08/2022  Integrity Bio-Chemical,    (S) Surfactant--surface    (S) Maltodextrin,
                                                                      LLC.                       tension reducing agent     dodecanoate.
                                                                                for use in production
                                                                                enhancement in oil wells
                                                                                (industrial),
                                                                                Emulsifier, Surface
                                                                                reduction Household and
                                                                                industrial detergents,
                                                                                Wetting agent Personal
                                                                                care, Agriculture,
                                                                                Surfactants--as raw
                                                                                materials for use in the
                                                                                manufacture of
                                                                                industrial products and
                                                                                consumer and household
                                                                                products products (e.g.,
                                                                                cleaners).

P-22-0135.............................            2      07/08/2022  Integrity Bio-Chemical,    (S) Surfactant--surface    (S) Maltodextrin,
                                                                      LLC.                       tension reducing agent     tetradecanoate.
                                                                                for use in production
                                                                                enhancement in oil wells
                                                                                (industrial),
                                                                                Emulsifier, Surface
                                                                                reduction Household and
                                                                                industrial detergents,
                                                                                Wetting agent Personal
                                                                                care, Agriculture,
                                                                                Surfactants--as raw
                                                                                materials for use in the
                                                                                manufacture of
                                                                                industrial products and
                                                                                consumer and household
                                                                                products products (e.g.,
                                                                                cleaners).
P-22-0137.............................            2      07/18/2022  Sachem Inc...............  (G) Intermediate for       (G) alkyl dialkylamine.
                                                                                making quaternary
                                                                                ammonium salt.
P-22-0138.............................            3      07/18/2022  Sachem Inc...............  (S) Intermediate for       (G) Tetraalkylammonium
                                                                                making hydroxide salt.     chloride.
P-22-0140.............................            2      07/02/2022  CBI......................  (G) Corrosion inhibitor..  (G) 6-[(alkyl-1-
                                                                                oxohexyl)amino]-hexanoic
                                                                                acid, compd. with
                                                                                cyclohexylamine (1:1).
P-22-0144.............................            1      06/30/2022  United Color               (G) Intermediate.........  (G) Alkylated
                                                                      Manufacturing.                                        PhenylNaphthylamine.
P-22-0145.............................            2      07/01/2022  Allnex USA Inc...........  (S) The PMN substance      (G) Alkanoic acid, trialkyl-,
                                                                                will be used as a          diester with carbomonocycle
                                                                                reactive-diluent in a      bis(alkyleneoxy)]bis[alkaned
                                                                                polyol component of a 2K   iol].
                                                                                (Isocyanate-Polyol)
                                                                                Urethane coating system
                                                                                for interior concrete
                                                                                floor sealant or
                                                                                interior/exterior paver
                                                                                sealer.
P-22-0146.............................            3      07/06/2022  Allnex USA Inc...........  (S) Water based            (G) Carbamic acid, N,N',N''-
                                                                                formaldehyde free          1,3,5-triazine-2,4,6-
                                                                                crosslinker.               triyltris-, mixed alkyl
                                                                                alkoxy triesters.
P-22-0147.............................            1      07/12/2022  VP Racing Fuels, Inc.....  (S) Feedstock for          (S) Hydrocarbons, C5-10.
                                                                                Gasoline to include
                                                                                Racing Fuels.
P-22-0147A............................            2      07/21/2022  VP Racing Fuels, Inc.....  (S) Feedstock for          (S) Hydrocarbons, C5-10.
                                                                                Gasoline to include
                                                                                Racing Fuels.
P-22-0148.............................            2      07/25/2022  CBI......................  (G) Intermediate.........  (G) Substituted benzonitrile.
P-22-0150.............................            1      07/25/2022  CBI......................  (G) Photolithography.....  (G) Sulfonium, tricarbocyclic-
                                                                                , alpha, alpha, beta, beta-
                                                                                polyhalopolyhydro-
                                                                                heteropolycyclic-5-
                                                                                alkanesulfonate (1:1).
P-22-0151.............................            1      07/26/2022  Locus Fermentation         (G) Surfactant for         (G) Glycolipids, sophorose-
                                                                      Solutions.                 commercial applications.   contg., yeast-fermented,
                                                                                from glycerides and
                                                                                carbohydrates.
SN-21-0013A...........................            3      07/15/2022  Koch Agronomic Services..  (S) Additive for urea      (S) Urea, reaction products
                                                                                ammonium nitrate, UAN,     with N-butylphosphorothioic
                                                                                fertilizer for boom        triamide and formaldehyde.
                                                                                spray applications.
SN-22-0010............................            1      07/15/2022  CBI......................  (S) Monomer chemical,      (S) 2-Oxazolidinone, 3-
                                                                                reactive diluent in UV     ethenyl-5-methyl-.
                                                                                coating formulations and
                                                                                reactive diluent,
                                                                                additive in UV adhesive
                                                                                formulations.

SN-22-0011............................            1      07/18/2022  CBI......................  (G) Chemical Intermediate  (G)
                                                                                Haloalkylfurancarboxaldehyde
                                                                                .
--------------------------------------------------------------------------------------------------------------------------------------------------------
* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required information and documents have been provided
  with the submission prior to the start of the 90 day review period, and in no way reflects the final status of a complete submission review.

    In Table II of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the NOCs
that have passed an initial screening by EPA during this period: The
EPA case number assigned to the NOC including whether the submission
was an initial or amended submission, the date the NOC was received by
EPA, the date of commencement provided by the submitter in the NOC, a
notation of the type of amendment (e.g., amendment to generic name,
specific name, technical contact information, etc.) and chemical
substance identity.

                              Table II--NOCs Approved * From 7/1/2022 to 7/31/2022
----------------------------------------------------------------------------------------------------------------
                               Received     Commencement      If amendment, type of
          Case No.               date           date                amendment             Chemical substance
----------------------------------------------------------------------------------------------------------------
J-22-0013..................   07/25/2022        07/15/2022  N.......................  (G) Genetically modified
                                                                                microorganism for
                                                                                chemical production.
P-15-0691..................   07/26/2022        07/22/2022  N.......................  (G) Acrylate, polymer with
                                                                                substituted
                                                                                ethyleneamine.
P-18-0289..................   07/01/2022        06/22/2022  N.......................  (G) 2-
                                                                                (2(methylcaboxymonocyclic
                                                                                )amino)ethoxy)-alcohol,.
P-18-0290..................   07/01/2022        06/22/2022  N.......................  (G) Carbomonocylic-
                                                                                oxazolidine,.
P-19-0037..................   07/10/2022        05/27/2022  N.......................  (G) D-glucaric acid, mixed
                                                                                alkali metal salt.
P-19-0135..................   07/19/2022        07/08/2022  N.......................  (G) Alkyl polyoxyethylene
                                                                                ethers,
                                                                                carboxymethylated.
P-21-0067..................   06/30/2022        06/24/2022  N.......................  (G) Arylfurandione,
                                                                                [bis(trihaloalkyl)alkylid
                                                                                ene]bis-, polymer with
                                                                                alkanediamine.
P-21-0217..................   07/28/2022        07/06/2022  N.......................  (G) Multi-walled carbon
                                                                                nanotubes.
----------------------------------------------------------------------------------------------------------------
* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
  information and documents have been provided with the submission.

    In Table III of this unit, EPA provides the following information
(to the extent such information is not subject to a CBI claim) on the
test information that has been received during this time period: The
EPA case number assigned to the test information; the date the test
information was received by EPA, the type of test information
submitted, and chemical substance identity.

                         Table III--Test Information Received From 7/1/2022 to 7/31/2022
----------------------------------------------------------------------------------------------------------------
                                                              Received       Type of test
                         Case No.                               date         information      Chemical substance
----------------------------------------------------------------------------------------------------------------
P-14-0712.................................................   07/25/2022  Polychlorinated      (S) Waste
                                                                          Dibenzodioxins and   plastics,
                                                                          Polychlorinated      pyrolyzed, C5-55
                                                                          dibenzofurans        fraction.
                                                                          Testing.
----------------------------------------------------------------------------------------------------------------

    If you are interested in information that is not included in these
tables, you may contact EPA's technical information contact or general
information contact as described under FOR FURTHER INFORMATION CONTACT
to access additional non-CBI information that may be available.
    Authority: 15 U.S.C. 2601 et seq.

    Dated: August 10, 2022.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2022-17474 Filed 8-12-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4611-4612]
[FR Doc No: 2022-01788]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0980]

Assessing the Credibility of Computational Modeling and
Simulation in Medical Device Submissions; Draft Guidance for Industry
and Food and Drug Administration Staff; Availability; Extension of
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice of availability that
appeared in the Federal Register of December 23, 2021. In the notice of
availability, FDA requested comments on draft guidance for industry and
FDA staff entitled ``Assessing the Credibility of Computational
Modeling and Simulation in Medical Device Submissions.'' The Agency is
taking this action in response to a request for an extension to allow
interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the document published
December 23, 2021 (86 FR 72969). Submit either electronic or written
comments on the draft guidance by March 24, 2022, to ensure that the
Agency considers your comment on this draft guidance before it begins
work on the final version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-0980 for ``Assessing the Credibility of Computational
Modeling and Simulation in Medical Device Submissions.'' 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>.
     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>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Assessing the Credibility of Computational Modeling and Simulation in
Medical Device Submissions'' to the Office of Policy, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Pras Pathmanathan, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1133, Silver Spring, MD 20993-0002, 301-
796-3490.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 23, 2021, FDA published a
notice of availability with a 60-day comment period to request comments
on draft guidance for industry and FDA staff entitled ``Assessing the
Credibility of Computational Modeling and Simulation in Medical Device
Submissions.''
    The Agency has received a request for an extension of the comment
period. The request conveyed concern that the current 60-day comment
period does not allow sufficient time to develop a meaningful or
thoughtful response.
    FDA has considered the request and is extending the comment period
for the notice of availability for 30 days, until March 24, 2022. The
Agency believes that a 30-day extension allows adequate time for
interested persons to submit comments without significantly

delaying guidance on these important issues.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Assessing
the Credibility of Computational Modeling and Simulation in Medical
Device Submissions.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This draft guidance document
is also available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
Persons unable to download an electronic copy of ``Assessing the
Credibility of Computational Modeling and Simulation in Medical Device
Submissions'' may send an email request to [email protected] to
receive an electronic copy of the document. Please use the document
number 1500056 and complete title to identify the guidance you are
requesting.

    Dated: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01788 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 34 (Thursday, February 20, 2020)]
[Notices]
[Pages 9931-9932]
[FR Doc No: 2020-03350]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0111]

Qualification of Drivers; Exemption Applications; Hearing

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt 17 individuals from the
hearing requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs) to operate a commercial motor vehicle (CMV) in interstate
commerce. The exemptions enable these hard of hearing and deaf
individuals to operate CMVs in interstate commerce.

DATES: The exemptions were applicable on January 21, 2020. The
exemptions expire on January 21, 2022.

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

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov/docket?D=FMCSA-2019-0111 and choose the document to review. If you do
not have access to the internet, you may view the docket online by
visiting the Docket Operations in Room W12-140 on the ground floor of
the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590,
between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal
holidays.

B. Privacy Act

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

II. Background

    On December 19, 2019, FMCSA published a notice announcing receipt
of applications from 17 individuals requesting an exemption from the
hearing requirement in 49 CFR 391.41(b)(11) to operate a CMV in
interstate commerce and requested comments from the public (84 FR
69820). The public comment period ended on January 21, 2020, and one
comment was received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting exemptions to these individuals would achieve
a level of safety equivalent to, or greater than, the level that would
be achieved by complying with Sec.  391.41(b)(11).
    The physical qualification standard for drivers regarding hearing
found in Sec.  391.41(b)(11) states that a person is physically
qualified to drive a CMV if that person first perceives a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000

Hz, and 2,000 Hz with or without a hearing aid when the audiometric
device is calibrated to American National Standard (formerly ASA
Standard) Z24.5--1951.
    This standard was adopted in 1970 and was revised in 1971 to allow
drivers to be qualified under this standard while wearing a hearing
aid, 35 FR 6458, 6463 (April 22, 1970) and 36 FR 12857 (July 3, 1971).

III. Discussion of Comments

    FMCSA received one comment in this proceeding. An anonymous
commenter stated that they want the drivers of CMVs to be as safe as
possible and that in their opinion, hearing is essential to the safe
operation of an 80,000 lb. CMV. The commenter pointed out the need to
hear sirens and noise associated with the vehicle to maintain an
appropriate level of safety. FMCSA acknowledges the concerns of the
commenter and considers each application for a hearing exemption on an
individual basis and exempts only those drivers who do not pose a risk
to public safety when granting the exemption achieves a level of safety
that is equivalent to or greater than the level that would be achieved
absent such exemption. The Agency has considered the available current
medical information and literature and is not aware of any data to
support the contention that hard of hearing and deaf individuals are at
an increased risk for a crash. FMCSA also reviewed a 2014 doctoral
dissertation by Birgitta Thorslund from the Department of Behavioural
Sciences and Learning at Link[ouml]ping University, Sweden, entitled,
``Effects of Hearing Loss on Traffic Safety and Mobility.'' Dr.
Thorslund concluded that ``drivers with (hearing loss) cannot be
considered an increased traffic safety risk . . . .'' In fact, Dr.
Thorslund noted, drivers with hearing loss are more likely to be more
cautious and adopt coping strategies such as reducing speed, ``using a
more comprehensive visual search behavior,'' and avoiding distracting
activities. In addition, the commenter did not provide any evidence to
support her opinion that FMCSA should no longer grant hearing
exemptions.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The Agency's decision regarding these exemption applications is
based on current medical information and literature, and the 2008
Evidence Report, ``Executive Summary on Hearing, Vestibular Function
and Commercial Motor Driving Safety.'' The evidence report reached two
conclusions regarding the matter of hearing loss and CMV driver safety:
(1) No studies that examined the relationship between hearing loss and
crash risk exclusively among CMV drivers were identified; and (2)
evidence from studies of the private driver's license holder population
does not support the contention that individuals with hearing
impairment are at an increased risk for a crash. In addition, the
Agency reviewed each applicant's driving record found in the Commercial
Driver's License Information System, for commercial driver's license
(CDL) holders, and inspections recorded in the Motor Carrier Management
Information System. For non-CDL holders, the Agency reviewed the
driving records from the State Driver's Licensing Agency. Each
applicant's record demonstrated a safe driving history. Based on an
individual assessment of each applicant that focused on whether an
equal or greater level of safety is likely to be achieved by permitting
each of these drivers to drive in interstate commerce as opposed to
restricting him or her to driving in intrastate commerce, the Agency
believes the drivers granted this exemption have demonstrated that they
do not pose a risk to public safety.
    Consequently, FMCSA finds that in each case exempting these
applicants from the hearing standard in Sec.  391.41(b)(11) is likely
to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must report any crashes or accidents as defined in Sec.
390.5; (2) each driver must report all citations and convictions for
disqualifying offenses under 49 CFR 383 and 49 CFR 391 to FMCSA; and
(3) each driver is prohibited from operating a motorcoach or bus with
passengers in interstate commerce. The driver must also have a copy of
the exemption when driving, for presentation to a duly authorized
Federal, State, or local enforcement official. In addition, the
exemption does not exempt the individual from meeting the applicable
CDL testing requirements.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the 17 exemption applications, FMCSA
exempts the following drivers from the hearing standard, Sec.
391.41(b)(11), subject to the requirements cited above:

Bart Beasom (PA)
David Billingsley (IN)
Stephen Daniels (KS)
Paul Ditimi (CT)
Herman Fleck (PA)
John Freeman (MA)
Nicholas Green (FL)
Richard Hall (KY)
John Malm (IL)
Mark Merrow (MI)
Joyann Nipper (IA)
Jeffry Patterson (OH)
William Ranson (AR)
Michael Steffen (IN)
Justin Stephen (SC)
Michelle Trott (TN)
Sherrie Willey (WA)

    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315(b).

     Issued on: February 11, 2020.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2020-03350 Filed 2-19-20; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 85, Number 107 (Wednesday, June 3, 2020)]
[Proposed Rules]
[Pages 34139-34141]
[FR Doc No: 2020-11822]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0460; Product Identifier 2018-SW-078-AD]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.A. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for Leonardo S.p.A. Model AW169 and AW189 helicopters. This proposed AD
was prompted by a report of a broken extrusion rubber window seal. This
proposed AD would require installation of a reinforcement around the
rubber filler wedge where the extrusion rubber window seal meets the
door's emergency exit handle. The FAA is proposing this AD to address
the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by July 20,
2020.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Leonardo
S.p.A. Helicopters, Emanuele Bufano, Head of Airworthiness, Viale
G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone +39-0331-
225074; fax +39-0331-229046; or at https://www.leonardocompany.com/en/home. You may view this service information at the FAA, Office of the
Regional Counsel, Operational Safety Branch, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0460; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the Mandatory Continuing Airworthiness Information (MCAI),
any comments received, and other information. The street address for
Docket Operations is listed above. Comments will be available in the AD
docket shortly after receipt.

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

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2020-0460;
Product Identifier 2018-SW-078-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. The FAA will
consider all comments received by the closing date and may amend this
NPRM because of those comments.
    The FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact received about this NPRM.

Discussion

    The European Aviation Safety Agency (now European Union Aviation
Safety Agency) (EASA), which is the Technical Agent for the Member
States of the European Union, has issued EASA AD 2018-0197, dated
September 5, 2018 (referred to after this as ``the MCAI''), to correct
an unsafe condition for all Leonardo S.p.A. Model AW169 helicopters and
certain Leonardo S.p.A Model AW189 helicopters. EASA advises of a
broken extrusion rubber window seal, part number A417AF001WB. According
to EASA, an investigation determined that the damage to the rubber
filler wedge of the rubber window seal could have been caused by the
excessive tension of the string applied during the installation of an
affected emergency exit handle. EASA advises that this condition, if
not corrected, could result in an excessive load to release the
emergency exit window, possibly resulting in delayed evacuation of
helicopter occupants during an emergency. EASA states that, due to
design similarities, the same unsafe condition could exist or develop
on certain Model AW189 helicopters. To correct this condition, EASA AD
2018-0197 requires installation of a reinforcement around the rubber
filler wedge where the extrusion rubber window seal meets the door's
emergency exit handle.
    You may examine the MCAI in the AD docket on the internet at
https://www.regulations.gov by searching for

and locating Docket No. FAA-2020-0460.

Related Service Information Under 1 CFR Part 51

    Leonardo Helicopters has issued Alert Service Bulletin 169-094,
Revision A, dated August 13, 2018, and Alert Service Bulletin 189-170,
dated July 25, 2018. This service information describes procedures for
installation of a reinforcement around the rubber filler wedge where
the extrusion rubber window seal meets the door's emergency exit
handle. These documents are distinct since they apply to different
aircraft models.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    These products have been approved by the aviation authority of
another country, and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with the State of Design
Authority, the FAA has been notified of the unsafe condition described
in the MCAI and service information referenced above. The FAA is
proposing this AD after evaluating all the relevant information and
determining the unsafe condition described previously is likely to
exist or develop on other products of these same type designs.

Proposed Requirements of This NPRM

    This proposed AD would require accomplishing the actions specified
in the service information described previously.

Costs of Compliance

    The FAA estimates that this proposed AD affects 10 helicopters of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
               Labor cost                   Parts cost         Cost per product         Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 6 work-hours x $85 per hour = Up                $0  Up to $510................  Up to $5,100.
 to $510.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. The FAA does not control warranty
coverage for affected individuals. As a result, the FAA has included
all known costs in this cost estimate.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

Leonardo S.p.A.: Docket No. FAA-2020-0460; Product Identifier 2018-
SW-078-AD.

(a) Comments Due Date

    The FAA must receive comments by July 20, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the Leonardo S.p.A. helicopters identified in
paragraphs (c)(1) and (2) of this AD, certificated in any category,
equipped with an affected part defined as internal emergency exit
handle, part number (P/N) 8G9500L00151, and external emergency exit
handle, P/N 8G9500L00251.
    (1) Model AW169 helicopters, all serial numbers.
    (2) Model AW189 helicopters, all serial numbers, except those
helicopters with emergency exit windows equipped with strap P/N
A487A003A, or helicopters with bubble windows P/N 8G5620F00112.

(d) Subject

    Joint Aircraft Service Component (JASC) Code 5600, Windows.

(e) Reason

    This AD was prompted by a report of a broken extrusion rubber
window seal; an investigation determined the likely cause was
excessive tension of the string applied during the installation of
an affected emergency exit handle. The FAA is issuing this AD to
address this condition, which, if not addressed, could result in an
excessive load required to release the emergency exit window,
possibly resulting in delayed evacuation of helicopter occupants
during an emergency.

(f) Compliance

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

(g) Modification

    (1) For Leonardo S.p.A. Model AW169 helicopters equipped with a
passenger sliding door configuration, cabin main assembly P/N
6F5330A00131 or P/N

6F5330A00132: Within 750 hours time-in-service (TIS) or 24 months,
whichever occurs first after the effective date of this AD, install
the retro-modification P/N 6F5600P00111 on the rubber filler wedge
of all affected emergency exit handles in accordance with Part I,
Steps 1 through 8 of the Accomplishment Instructions of Leonardo
Helicopters Alert Service Bulletin 169-094, Revision A, dated August
13, 2018, except you are required to replace the affected emergency
exit handles and are not required to discard the filler wedges.
    (2) For Leonardo S.p.A. Model AW169 helicopters equipped with a
passenger hinged door configuration, cabin main assembly VIP P/N
6F5330A00831: Within 750 hours TIS or 24 months, whichever occurs
first after the effective date of this AD, install the retro-
modification P/N 6F5600P00111 on the rubber filler wedge of all
affected emergency exit handles in accordance with Part II, steps 1
through 6 of the Accomplishment Instructions of Leonardo Helicopters
Alert Service Bulletin 169-094, Revision A, dated August 13, 2018,
except you are required to replace the affected emergency exit
handles and are not required to discard the filler wedges.
    (3) For Leonardo S.p.A. Model AW189 helicopters: Within 750
hours TIS or 24 months, whichever occurs first after the effective
date of this AD, install the retro-modification P/N 8G5600P00211 on
the rubber filler wedge of all affected emergency exit handles in
accordance with steps 1 through 11 of the Accomplishment
Instructions of Leonardo Helicopters Alert Service Bulletin 189-170,
dated July 25, 2018, except you are required to replace the affected
emergency exit handles and are not required to discard the filler
wedges.

(h) Alternative Methods of Compliance (AMOCs)

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

(i) Related Information

    (1) The subject of this AD is addressed in European Aviation
Safety Agency (now European Union Aviation Safety Agency) (EASA) AD
2018-0197, dated September 5, 2018. This EASA AD may be found in the
AD docket on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-0460.
    (2) For service information identified in this AD, contact
Leonardo S.p.A. Helicopters, Emanuele Bufano, Head of Airworthiness,
Viale G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone
+39-0331-225074; fax +39-0331-229046; or at https://www.leonardocompany.com/en/home. You may view this service
information at the FAA, Office of the Regional Counsel, Operational
Safety Branch, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177.

    Issued on May 27, 2020.
Lance T. Gant,
 Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-11822 Filed 6-2-20; 8:45 am]
 BILLING CODE 4910-13-P