[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)]
[Notices]
[Pages 23671-23677]
[FR Doc No: 2018-10789]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0713; FRL-9972-08]

Certain New Chemical Substances; Receipt and Status Information
for November 2017

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
November 1, 2017 to November 30, 2017.

DATES: Comments identified by the specific case number provided in this
document must be received on or before June 21, 2018.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2017-0713, and the specific case number for the
chemical substance related to your comment, by one of the following
methods:
     Federal eRulemaking Portal: http://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.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Jim Rahai, Information
Management Division (MC 7407M), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; 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. What action is the Agency taking?

    This document provides the receipt and status reports for the
period from November 1, 2017 to November 30, 2017. 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.

B. 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 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: http://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.

C. Does this action apply to me?

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

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 this 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 http://www.epa.gov/dockets/comments.html.

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 49 PMN/SNUN/MCANs received 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 received by
EPA during this period: The EPA case number assigned to the notice, a
notation of 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 and the version column
will note ``Initial''. 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 amendments in sequence as
``1'', ``2'', ``3'', etc.

                                              Table I--PMN/SNUN/MCANs Received From 11/1/2017 to 11/30/2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
                             Submission document
         Case No.                   type               Version      Received date       Manufacturer                 Use             Chemical substance
--------------------------------------------------------------------------------------------------------------------------------------------------------
P-16-0531A...............  Amendment.............               2        11/17/17  Clariant Corporation..  (G) Additive for use    (G) Alkyloxy
                                                                                in mineral processing.  propanamine.
P-17-0003A...............  Amendment.............               7        11/01/17  CBI...................  (G) Printing ink        (G) Styrene(ated)
                                                                                applications.           copolymer with
                                                                                alkyl(meth)acrylate,
                                                                                and (meth)acrylic
                                                                                acid.

P-17-0152A...............  Amendment.............               7        11/16/17  CBI...................  (G) Additive in home    (G) Poly-(2-methyl-1-
                                                                                care products.          oxo-2-propen-1-yl)
                                                                                ester with
                                                                                ethanaminium, N,N,N-
                                                                                trialkyl, chloride
                                                                                and methoxypoly(oxy-
                                                                                1,2-ethanediyl).
P-17-0153A...............  Amendment.............               3        11/17/17  Clariant Corporation..  (S) Neutralizing agent  (S) D-Glucitol, 1-
                                                                                for paints and          deoxy-1-
                                                                                coatings.               (dimethylamino)-.
P-17-0195A...............  Amendment.............               4        11/28/17  CBI...................  (G) For manufacturing   (G) 1,3-Propanediol,2-
                                                                                modified Ethylene       methylene-,
                                                                                vinyl alcohol           substituted,
                                                                                copolymer.
P-17-0214A...............  Amendment.............               2        11/16/17  Clariant Corporation..  (S) Pour point          (G) 2-Propenoic acid,
                                                                                depressant for use in   polymer with alkene
                                                                                petroleum products.     and alkenyl acetate,
                                                                                alkyl 2-alkyl
                                                                                isoalkyl esters.
P-17-0215A...............  Amendment.............               2        11/25/17  Clariant Corporation..  (S) Lubricant for use   (G) Copolymer of
                                                                                in metal working        alpha-olefin and
                                                                                fluids.                 dibutyl maleate.
P-17-0283A...............  Amendment.............               6        11/21/17  CBI...................  (G) Lubricating oil     (G) Arenesulfonic
                                                                                additive for            acid, alkyl
                                                                                automotive engine       derivatives, metal
                                                                                oils.                   salts.
P-17-0336A...............  Amendment.............               5        11/14/17  CBI...................  (S) Cathode material    (S) Aluminum cobalt
                                                                                for lithium ion         lithium nickel
                                                                                batteries.              oxide.
P-17-0337A...............  Amendment.............               5        11/14/17  CBI...................  (S) Cathode material    (S) Aluminum boron
                                                                                for lithium ion         cobalt lithium
                                                                                batteries.              nickel oxide.
P-17-0338A...............  Amendment.............               5        11/14/17  CBI...................  (S) Cathode material    (S) Aluminum boron
                                                                                for lithium ion         cobalt lithium
                                                                                batteries.              magnesium nickel
                                                                                oxide.
P-17-0346A...............  Amendment.............               3        11/13/17  CBI...................  (G) Destructive use...  (G) Triarylalkyl
                                                                                phosphonium halide
                                                                                salt.
P-17-0375A...............  Amendment.............               2        11/30/17  Asahi Kasei America,    (G) Paint additive....  (G) 2-Oxepanone,
                                                                                Inc.                                            polymer with
                                                                                diisocyanatohexane,
                                                                                alkyl-
                                                                                ((hydroxyalkyl)-
                                                                                alkanediol and
                                                                                isocyanato-
                                                                                (isocyanatoalkyl)-
                                                                                trialkylcyclohexane,
                                                                                di-alkyl malonate-
                                                                                and polyalkylene
                                                                                glycol mono-Me ether-
                                                                                blocked, reaction
                                                                                products with
                                                                                (methylalkyl)-
                                                                                propanamine.
P-17-0396A...............  Amendment.............               3        11/02/17  CBI...................  (S) Intermediate for a  (G) Aminoalkylated
                                                                                polyurethane catalyst.  imidazole.
P-18-0001A...............  Amendment.............               6        11/10/17  Nexus Fuels...........  (G) Additive..........  (G) Carbon compound
                                                                                derived from plastic
                                                                                depolymerization.
P-18-0003A...............  Amendment.............               4        11/30/17  CBI...................  (S) Lubricant for       (G) Fatty acids,
                                                                                metal working           diesters with
                                                                                applications.           dihydroxyalkane,
                                                                                Fatty acids, esters
                                                                                with
                                                                                dihydroxyalkane.
P-18-0009A...............  Amendment.............               2        11/07/17  CBI...................  (G) Lubricant additive  (G) Phosphonic acid,
                                                                                dimethyl ester,
                                                                                polymer with alkyl
                                                                                diols.
P-18-0013A...............  Amendment.............               2        11/02/17  Shin-Etsu Microsi.....  (G) Microlithography    (G) Substituted-
                                                                                for electronic device   triphenylsulfonium,
                                                                                manufacturing.          inner salt.
P-18-0014A...............  Amendment.............               2        11/02/17  Shin-Etsu Microsi.....  (G) Microlithography    (G) Sulfonium,
                                                                                for electronic device   triphenyl-, salt
                                                                                manufacturing.          with disubstituted-
                                                                                heterocyclic
                                                                                compound (1:1).
P-18-0016A...............  Amendment.............               2        11/21/17  CBI...................  (G) Additives used in   (G) Aromatic
                                                                                Semiconductor chip      sulfonium tricyclo
                                                                                manufacturing.          fluoroalkyl sulfonic
                                                                                acid salt.
P-18-0024A...............  Amendment.............               2        11/15/17  CBI...................  (S) Epoxy hardner/      (G) Substituted
                                                                                curative.               cashew, nutshell
                                                                                liquid, polymer with
                                                                                epichlorohydrin,
                                                                                phosphate.
P-18-0031A...............  Amendment.............               3        11/06/17  CBI...................  (G) Ingredient for      (G) Substituted
                                                                                industrial coating.     dicarboxylic acid,
                                                                                polymer with various
                                                                                alkanediols.
P-18-0035A...............  Amendment.............               2        11/01/17  Evonik Corporation....  (G) Monomer for         (G) Methacrylic acid
                                                                                polymer applications.   heterocyclic alkyl
                                                                                ester, methacrylic
                                                                                acid heterocyclic
                                                                                alkyl ester.
P-18-0038A...............  Amendment.............               3        11/04/17  Highland Logistics LLC  (S) Solution polymer    (G) Acrylic acid,
                                                                                incorporating           copolymer with
                                                                                catalyst monomer for    itaconic acid,
                                                                                generation of singlet   alkenyloxyethoxylate
                                                                                oxygen.                 , hydroxyalkyl
                                                                                methacrylate. alkyl
                                                                                alkenyylocyethoxylat
                                                                                e ammonium sulfate
                                                                                salt and
                                                                                polyhalovinylbenzylo
                                                                                xoxanthen sodium
                                                                                salt benzoate.
P-18-0039A...............  Amendment.............               3        11/14/17  CBI...................  (G) Curing agent......  (G) 2-propenenitrile,
                                                                                reaction products
                                                                                with cycloaliphatic
                                                                                diamine, araliphatic
                                                                                diamine, bisphenol A-
                                                                                epichlorohydrin-
                                                                                polyethylene glycol
                                                                                polymer and N-alkyl
                                                                                substituted alkyl.
                                                                                amine.

P-18-0040................  Initial submission....               1        11/06/17  Allnex USA Inc........  (S) Binder for ultra    (G) Alkanedioic acid,
                                                                                violet (UV) curable     polymers with
                                                                                coating resin.          alkanoic acid-
                                                                                dipentaerythritol
                                                                                reaction products,
                                                                                substituted
                                                                                alkanedioc acid,
                                                                                substituted alkanoic
                                                                                acid, isocyanato-
                                                                                (isocyanatoalkyl)-
                                                                                alkyl substituted
                                                                                carbomoncycle and
                                                                                alkyl substituted
                                                                                alkanediol.
P-18-0041................  Initial submission....               1        11/06/17  CBI...................  (G) Intermediate        (S) 2,5-furandione,
                                                                                polyol for further      polymer with 2-ethyl-
                                                                                reaction.               2-(hydroxymethyl)-
                                                                                1,3-propanediol,
                                                                                3a,4,5,6,7,7a-
                                                                                hexahydro-4,7-
                                                                                methano-1H-inden-
                                                                                5(or 6)-yl ester,
                                                                                ester with 2,3-
                                                                                dihydroxypropyl
                                                                                neodecanoate.
P-18-0042................  Initial submission....               1        11/06/17  CBI...................  (G) Industrial coating  (S) 2,5-furandione,
                                                                                polymer with 2-ethyl-
                                                                                2-(hydroxymethyl)-
                                                                                1,3-propanediol,
                                                                                3a,4,5,6,7,7a-
                                                                                hexahydro-4,7-
                                                                                methano-1H-inden-
                                                                                5(or 6)-yl ester,
                                                                                ester with 2,3-
                                                                                dihydroxypropyl
                                                                                neodecanoate,
                                                                                polymer with 5-
                                                                                isocyanato-1-
                                                                                (isocyanatomethyl)-
                                                                                1,3,3-
                                                                                trimethylcyclohexane
                                                                                , 2-hydroxyethyl
                                                                                acrylate- and 2-
                                                                                hydroxyethyl
                                                                                methacrylate-
                                                                                blocked.
P-18-0042A...............  Amendment.............               2        11/12/17  CBI...................  (G) Industrial coating  (S) 2,5-furandione,
                                                                                polymer with 2-ethyl-
                                                                                2-(hydroxymethyl)-
                                                                                1,3-propanediol,
                                                                                3a,4,5,6,7,7a-
                                                                                hexahydro-4,7-
                                                                                methano-1H-inden-
                                                                                5(or 6)-yl ester,
                                                                                ester with 2,3-
                                                                                dihydroxypropyl
                                                                                neodecanoate,
                                                                                polymer with 5-
                                                                                isocyanato-1-
                                                                                (isocyanatomethyl)-
                                                                                1,3,3-
                                                                                trimethylcyclohexane
                                                                                , 2-hydroxyethyl
                                                                                acrylate- and 2-
                                                                                hydroxyethyl
                                                                                methacrylate-
                                                                                blocked.
P-18-0043................  Initial submission....               1        11/07/17  Evonik Corporation....  (S) As plasticizer or   (S) 1,4-
                                                                                fast fuser in PVC-      benzenedicarboxylic
                                                                                plastisols; for         acid, 1,4-dipentyl
                                                                                flooring, wall paper,   ester, branched and
                                                                                coated fabrics,         linear.
                                                                                underbodycoating.
                                                                                (S) Use as a
                                                                                laboratory agent.
                                                                                (S) Use in formulation
                                                                                or re-packing.
                                                                                (S) Additives for
                                                                                flexibilization of
                                                                                paints and lacquers.
                                                                                (S) As processing aid
                                                                                or fast fuser in PVC
                                                                                dry blends; for
                                                                                flooring, coated
                                                                                fabrics films sheets
                                                                                tubes hoses.
P-18-0044................  Initial submission....               1        11/07/17  CBI...................  (G) Intermediate        (G) Fatty acids.
                                                                                species.
P-18-0045................  Initial submission....               1        11/07/17  CBI...................  (G) Application         (G) Fatty acids,
                                                                                coating.                alkyl esters.
P-18-0046................  Initial submission....               2        11/14/17  Allnex USA Inc........  (S) UV curable coating  (G) Substituted
                                                                                resin.                  carbomonocycle,
                                                                                polymer with
                                                                                diisocyanatoalkane,
                                                                                substituted
                                                                                alkylacrylate-
                                                                                blocked.
P-18-0047................  Initial submission....               2        11/09/17  CBI...................  (S) EGDB will be a      (S) 1,2-ethanediol,
                                                                                safety enhancing        1,2-dibenzoate.
                                                                                stabilizer for
                                                                                peroxides as well as
                                                                                a replacement for a
                                                                                more hazardous
                                                                                phthalate in current
                                                                                market products
                                                                                (S) Used for the
                                                                                curing of unsaturated
                                                                                polyester resins and
                                                                                methacrylic resins
                                                                                mainly in the
                                                                                temperature range of
                                                                                60[deg]C and higher.
P-18-0048................  Initial submission....               1        11/13/17  Colonial Chemical, Inc  (S) Metal working.....  (S) Acetic acid, 2-(2-
                                                                                butoxyethoxy)-.
P-18-0049................  Initial submission....               1        11/16/17  Solvay Fluorides LLC..  (G) Coating component/  (G) Mixed metal
                                                                                processing aid.         halide.
P-18-0050................  Initial submission....               1        11/16/17  CBI...................  (G) Raw material in     (G) Alkane,
                                                                                industrial coatings.    diisocyanato-,
                                                                                homopolymer, alkyl
                                                                                dihydrogen phosphate-
                                                                                and polyalkylene
                                                                                glycol mono-alkyl
                                                                                ether-.

P-18-0051................  Initial submission....               2        11/21/17  Allnex USA Inc........  (S) Waterborne UV       (G) Alkenoic acid,
                                                                                curable coating resin   reaction products
                                                                                binder for inkjet,      with
                                                                                ink or overprint        [oxybis(alkylene)]bi
                                                                                varnish.                s[(substituted
                                                                                alkyl)-alkanediol],
                                                                                polymers with
                                                                                isocyanatoalkane and
                                                                                substituted alkanoic
                                                                                acid, substituted
                                                                                monoacrylate
                                                                                alkanoate-blocked.
P-18-0052................  Initial submission....               1        11/20/17  Shin Etsu Silicones of  (G) Coating agent.....  (G)
                                                                                America.                                        Perfluoroalkylethyl-
                                                                                and vinyl-modified
                                                                                organopolysiloxane.
P-18-0053................  Initial submission....               1        11/20/17  Shin Etsu Silicones of  (G) Coating agent.....  (G)
                                                                                America.                                        Perfluoroalkylethyl-
                                                                                and vinyl-modified
                                                                                organopolysiloxane.
P-18-0054................  Initial submission....               1        11/20/17  CBI...................  (G) Paint.............  (G) 2-alkenoic acid,
                                                                                2-alkyl-, 2-alkyl
                                                                                ester, polymer with
                                                                                alkyl 2-alkenoate, 2-
                                                                                substitutedalkyl 2-
                                                                                alkenoate and 2-
                                                                                substitutedalkyl 2-
                                                                                alkyl-2-alkenoate,
                                                                                esters with
                                                                                carboxylic acids,
                                                                                tert alkylperoxoate
                                                                                initiated.
P-18-0055................  Initial submission....               1        11/22/17  CBI...................  (G) Catalyst..........  (G) Mixed metal
                                                                                oxide.
P-18-0056................  Initial submission....               2        11/29/17  CBI...................  (S) Drier for paints    (S) Cobalt
                                                                                and coatings.           neodecanoate
                                                                                propionate complex.
P-18-0056A...............  Amendment.............               3        11/30/17  CBI...................  (S) Drier for paints    (S) Cobalt
                                                                                and coatings.           neodecanoate
                                                                                propionate complex.
P-18-0059................  Initial submission....               1        11/30/17  EASTMAN Chemical        (S) Chemical            (S) Butanoic acid, 4-
                                                                                Company, Inc.           intermediate.           (dimethylamino)-,
                                                                                ethyl ester.
P-18-0060................  Initial submission....               1        11/30/17  EASTMAN Chemical        (S) Surfactant for      (S) 1-Butanaminium, 4-
                                                                                Company, Inc.           liquid dish, liquid     amino-N-(2-hydroxy-3-
                                                                                laundry and             sulfopropyl)-N, N-
                                                                                industrial hand wash;   dimethyl-4-oxo-, N-
                                                                                FDA related uses;       coco alkyl derivs.,
                                                                                export only volume of   inner salts.
                                                                                the TSCA manufactured
                                                                                NCS.
P-18-0061................  Initial submission....               2        11/30/17  CBI...................  (G) Industrial coating  (G) Alkyl
                                                                                hardners.               methacrylates,
                                                                                polymer with alkyl
                                                                                acrylates, styrene
                                                                                hydroxyalkyl
                                                                                acrylates, novalac
                                                                                epoxy and epoxy
                                                                                modified acrylic.
SN-17-0014A..............  Amendment.............               2        11/02/17  CBI...................  (G) Oilfield additive.  (S) Oxazolidine, 3,3'-
                                                                                methylenebis[5-
                                                                                methyl-.
SN-18-0001...............  Initial submission....               2        11/29/17  CBI...................  (S) Solution based      (G) Alkyl-dihydroxy-
                                                                                (<1% concentration)     methyl pyridin-
                                                                                oxidation catalyst      carboxylate Iron
                                                                                for the composite       chloride complex.
                                                                                market (fiber glass:
                                                                                insulation,
                                                                                filtration media,
                                                                                reinforcements,
                                                                                optical fibers)
                                                                                (oxidation catalyst
                                                                                for composite
                                                                                industry (e.g., for
                                                                                application to
                                                                                gelcoat-type finished
                                                                                goods such as boats,
                                                                                bowling balls, shower
                                                                                stalls and bathtubs,
                                                                                etc.).
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In Table II. of this unit, EPA provides the following information
(to the extent that such information is not subject to a CBI claim) on
the TMEs and/or Biotech Exemptions received by EPA during this period:
The EPA case number assigned to the TME and/or Biotech Exemption, the
submission document type (initial or amended), the version number, the
date the TME and/or Biotech Exemption was received by EPA, the
submitting manufacturer (i.e., domestic producer or importer), the
potential uses identified by the manufacturer in the TME and/or Biotech
Exemption, and the chemical substance identity.

                                       Table II--TMEs and Biotech Exemptions Received From 11/1/2017 to 11/30/2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
                              Submission document                   Received
         Case No.                     type             Version        date           Manufacturer                  Use              Chemical substance
--------------------------------------------------------------------------------------------------------------------------------------------------------
T-18-0001.................  Initial submission.....            1     11/16/17  CBI                       (S) Component in         (G) Renewable naptha.
                                                                                automotive gasoline/
                                                                                transportation fuel
                                                                                for consumer use..
H-18-0001A................  Amendment..............            2     11/06/17  CBI                       (G) Production of        (G) Modified
                                                                                Chemical.                transgenic
                                                                                microorganism.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In Table III. of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the NOCs
received by EPA during this period: The EPA case number assigned to the
NOC, the submission document type (initial or amended), 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 III-- NOCs Received From 11/1/2017 to 11/30/2017
----------------------------------------------------------------------------------------------------------------
                                                                           If amendment,
      Case No.            Submission       Received   Commencement date       type of        Chemical substance
                        document type        date                            amendment
----------------------------------------------------------------------------------------------------------------
P-05-0834...........  Initial               11/15/17           8/1/2006  ................  (S) 1,3-
                       submission.                                                          benzenedicarboxylic
                                                                                acid, polymer with
                                                                                1,4-butanediol,
                                                                                hexanedioic acid,
                                                                                1,6-hexanediol,
                                                                                hydrazine, 5-
                                                                                isocyanato-1-
                                                                                (isocyanatomethyl)-
                                                                                1,3,3-
                                                                                trimethylcyclohexane
                                                                                and 1,1'-
                                                                                methylenebis[4-
                                                                                isocyanatocyclohexan
                                                                                e], polyethylene
                                                                                glycol mono-me ether-
                                                                                blocked, amine-
                                                                                terminated.
P-06-0039...........  Initial               11/15/17          9/28/2006  ................  (S) Propanoic acid, 3-
                       submission.                                                          hydroxy-2-
                                                                                (hydroxymethyl)-2-
                                                                                methyl-, polymers
                                                                                with hydrazine, 2-
                                                                                hydroxymethylethyl-
                                                                                terminated
                                                                                polybutadiene, 5-
                                                                                isocyanato-1-
                                                                                (isocyanatomethyl)-
                                                                                1,3,3-
                                                                                trimethylcyclohexane
                                                                                and polypropylene
                                                                                glycol, compounds
                                                                                with triethylamine.
P-06-0306...........  Initial               11/15/17          6/15/2006  ................  (S) 1,3-
                       submission.                                                          benzenedicarboxylic
                                                                                acid, polymer with
                                                                                1,2-ethanediamine,
                                                                                hexanedioic acid,
                                                                                1,6-hexanediol,
                                                                                hydrazine and 1,1'-
                                                                                methylenebis[4-
                                                                                isocyanatocyclohexan
                                                                                e], polyethylene
                                                                                glycol mono-me ether-
                                                                                blocked.
P-07-0022...........  Initial               11/15/17          1/11/2007  ................  (S) 1,3-propanediol,
                       submission.                                                          2-ethyl-2-
                                                                                (hydroxymethyl)-,
                                                                                polymer with
                                                                                hydrazine, alpha-
                                                                                hydro-omega-
                                                                                hydroxypoly(oxy-1,4-
                                                                                butanediyl) and 1,1'-
                                                                                methylenebis[4-
                                                                                isocyanatocyclohexan
                                                                                e], polyethylene
                                                                                glycol mono-me ether-
                                                                                blocked.
P-11-0266...........  Initial               11/14/17          10/2/2017  ................  (G)
                       submission.                                                          Polypentaerythritol,
                                                                                mixed esters with
                                                                                straight and
                                                                                branched monoacids.
P-14-0729...........  Initial               11/27/17         11/21/2014  ................  (G) 'buta-1,3-diene
                       submission.                                                          reaction product
                                                                                with alkyl nitrile,
                                                                                alkyl benzene and
                                                                                alkyl acrylic acid'.
P-16-0095...........  Amendment........     11/17/17         10/19/2017  Specific Name...  (G) Phenol-
                                                                                formaldehyde resin.
P-16-0236...........  Initial               11/02/17         10/18/2017  ................  (S) Imidazo[4,5-
                       submission.                                                          d]imidazole-
                                                                                2,5(1h,3h)-dione,
                                                                                tetrahydro-1,3,4,6-
                                                                                tetrakis(methoxymeth
                                                                                yl)-, polymer with
                                                                                alpha-hydro-omega-
                                                                                hydroxypoly(oxy-1,2-
                                                                                ethanediyl),
                                                                                reaction product
                                                                                with polyethylene
                                                                                glycol mono[2,4,6-
                                                                                tris(1-
                                                                                phenylethyl)phenyl]
                                                                                ether.
P-16-0359...........  Initial               11/09/17          11/9/2017  ................  (G) Carbopolycycle-
                       submission.                                                          bis(diazonium),
                                                                                dihalo-, chloride
                                                                                (1:2), reaction
                                                                                products with metal
                                                                                hydroxide, 4-
                                                                                [(dioxoalkyl)amino]s
                                                                                ubstituted benzene,
                                                                                2-
                                                                                [(dioxoalkyl)amino]s
                                                                                ubstituted benzene,
                                                                                5-
                                                                                [(dioxoalkyl)amino]-
                                                                                2-hydroxy-
                                                                                substituted benzene
                                                                                and oxo-N-
                                                                                phenylalkanamide,.
P-16-0407...........  Initial               11/02/17         10/13/2017  ................  (G) Functionalized
                       submission.                                                          polyimide and
                                                                                functionalized
                                                                                polyamide.
P-16-0576...........  Initial               11/10/17         11/07/2017  ................  (G) Modified alkyl
                       submission.                                                          polyamine.
P-16-0577...........  Initial               11/10/17         11/09/2017  ................  (G) Alkyl polyamine.
                       submission.
P-17-0301A..........  Amendment........     11/27/17          6/01/2017  Contact           (G) Manganese
                                                                          Information.      bypyridine
                                                                                carboxylate complex.
P-96-0272...........  Initial               11/15/17          3/26/1996  ................  (S) 2,5-furandione,
                       submission.                                                          dihydro-, polymer
                                                                                with 1,2-ethanediol,
                                                                                1,1'-methylenebis[4-
                                                                                isocyanatobenzene]
                                                                                and 2,2'-
                                                                                oxybis[ethanol].
----------------------------------------------------------------------------------------------------------------

    In Table IV of this unit, EPA provides the following information
(to the extent such information is not subject to a CBI claim) on the
test information received by EPA 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 IV--Test Information Received from 11/1/2017 to 11/30/2017
----------------------------------------------------------------------------------------------------------------
           Case No.              Received date      Type of test information            Chemical substance
----------------------------------------------------------------------------------------------------------------
P-10-0470.....................        11/20/17  Analytical data summary of       (G) Fluoro modified, polyether
                                                 impurities of interest.          modified and alkyl modified
                                                                                polymethylsiloxane.
P-10-0471.....................      11/20/2017  Analytical data summary of       (G) Fluoro modified polyether
                                                 impurities of interest.          modified polyacrylate.
P-10-0472.....................      11/20/2017  Analytical data summary of       (G) Fluoro modified polyether
                                                 impurities of interest.          modified polyacrylate.
P-11-0063.....................       11/3/2017  Aerobic Transformation in Soil   (G) Perfluoroalkyl acrylate
                                                 (OECD 307).                      copolymer.
P-13-0930.....................       11/1/2017  (1) Short-Term Reproduction      (G) Substituted phenol.
                                                 Assay with Fathead Minnow
                                                 (Pimephales promelas) (OECD
                                                 229).
                                                (2) Amphibian Metamorphosis
                                                 Assay with African Clawed Frog
                                                 (Xenopus laevis) (OECD 231).
P-14-0323.....................       11/6/2017  (1) A 2-Week Study of P-14-0323  (G) Hydrochlorofluoropropene.
                                                 by Whole-Body Inhalation in
                                                 Sprague Dawley Rats (OCED 412).
                                                (2) A 2-Week Study of P-14-0323
                                                 by Whole-Body Inhalation in
                                                 Albino Rabbits (OCED 412)..
P-15-0121.....................      11/13/2017  Daphia 48 hr Acute               (S) Formaldehyde, polymer with
                                                 Immobilization Test (OCSPP       2-
                                                 850.1010 ).                      aminocyclopentanemethanamine,
                                                                                1,4-butanediamine, 1,2-
                                                                                cyclohexanediamine, 1,6-
                                                                                hexanediamine, hexahydro-1H-
                                                                                azepine and 2-methyl-1,5,-
                                                                                pentanediamine.

P-16-0393.....................       11/9/2017  (1) Single Cell Gel              (G) Di-substituted
                                                 Electrophoresis (Comet).         benzenedicarboxylic acid
                                                (2) Assay in the Male Rat: in     ester.
                                                 vivo(OECD 489).
                                                (3) (3) V79 HPRT Gene Mutation
                                                 Assay (OECD 476).
P-16-0393.....................       11/9/2017  Toxicity to Activated Sludge in  (G) Di-substituted
                                                 a Respiration Inhibition Test    benzenedicarboxylic acid
                                                 (OECD 209).                      ester.
P-16-0393.....................       11/9/2017  (1) Determination of Density     (G) Di-substituted
                                                 (OECD 109).                      benzenedicarboxylic acid
                                                (2) Determination of Adsorption   ester.
                                                 Coefficient (OECD 121).
                                                (3) Acute Dermal Toxicity
                                                 (Limit Test) in the rat.
                                                (4) Preliminary Toxicity Study
                                                 by Oral Gavage Adminstration
                                                 to Han Wistar Rats for 2 Weeks.
P-16-0393.....................       11/9/2017  Extraction Data................  (G) Di-substituted
                                                                                benzenedicarboxylic acid
                                                                                ester.
P-16-0393.....................       11/9/2017  (1) Acute Toxicity Test to       (G) Di-substituted
                                                 Earthworm.                       benzenedicarboxylic acid
                                                (2) Daphnia sp., Reproduction     ester.
                                                 Test (OECD 211).
                                                (3) Juvenile Growth Test of CBI
                                                 (OECD 215).
                                                (4) Seed Germination/Root
                                                 Elongation Toxicity of CBI.
                                                (5) Inherent Biodegradation
                                                 Test of CBI.
P-16-0543.....................      11/27/2017  Industrial Hygiene Exposure      (G) Halogenophosphoric acid
                                                 Assessment Report.               metal salt.
P-17-0153.....................      11/17/2017  Dose Range Finding Study for     (S) D-Glucitol, 1-deoxy-1-
                                                 Reproduction/Developmental       (dimethylamino)-.
                                                 Toxicity Screening Test of
                                                 Genamin DMG By Oral Gavage in
                                                 Sprague Dawley Rats.
P-17-0187.....................       11/2/2017  Surface Tension Data...........  (G) Polymer with benzoic acid
                                                                                tetra halogen hydroxy
                                                                                tetrahalogen oxo H xanthenyl
                                                                                alkenylaryl alkyl ester
                                                                                alkalai metal salt, butyl-2-
                                                                                propenoate, ethenyl
                                                                                neodecanoate, methyl-2-methyl-
                                                                                2- propenoate and 2-methyl-2-
                                                                                propenoic acid.
P-17-0218.....................       11/8/2017  Local Lymph Node Assay in Mice   (S) Bicyclo[2.2.1]heptane-1-
                                                 (OECD 429).                      methanesulfonic acid, 7,7-
                                                                                dimethyl-2-oxo-, compd. with
                                                                                N,N-diethylethanamine (1:1).
P-17-0252.....................       11/2/2017  Particle Abatement System......  (S) 1H,3H-Naphtho[1,8-cd]pyran-
                                                                                1,3-dione, 5-Nitro.
P-17-0380.....................      11/27/2017  Water Extractability in pH 2     (G) Amine- and hydroxy-
                                                 buffer study.                    functional acrylic polymer.
P-17-0380.....................      11/27/2017  Growth Inhibition Test with the  (G) Amine- and hydroxy-
                                                 Unicellular Green Alga,          functional acrylic polymer.
                                                 Pseudokirchneriella
                                                 subcapitata (OECD 201).
SN-15-0009....................      11/30/2017  Determination of effects in      (G) Fatty Acid amide.
                                                 sediment on emergence of the
                                                 midge, Chironomus riparius
                                                 (OECD 218).
----------------------------------------------------------------------------------------------------------------

    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: May 4, 2018.
Pamela Myrick,
Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2018-10789 Filed 5-21-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 171 (Wednesday, September 2, 2020)]
[Notices]
[Pages 54580-54581]
[FR Doc No: 2020-19385]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1153]

Post-Marketing Pediatric-Focused Product Safety Reviews;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is establishing a
public docket to collect comments related to the post-marketing
pediatric-focused safety reviews of products posted between September
23, 2019, and September 1, 2020, on FDA's website but not presented at
the September 15, 2020, Pediatric Advisory Committee (PAC) meeting.
These reviews are intended to be available for review and comment by
members of the PAC, interested parties (such as academic researchers,
regulated industries, consortia, and patient groups), and the general
public.

DATES: Submit either electronic or written comments by September 22,
2020.

ADDRESSES: FDA is establishing a docket for public comment on this
document. The docket number is FDA-2020-N-1153. The docket will close
on September 22, 2020. Submit either electronic or written comments by
that date. Please note that late, untimely comments will not be
considered. Electronic comments must be submitted on or before
September 22, 2020. The https://www.regulations.gov electronic filing
system will accept comments until 11:59 p.m. Eastern Time at the end of
September 22, 2020. Comments received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to make 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-2020-N-1153 for ``Post-Marketing Pediatric-Focused Product Safety
Reviews; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), 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.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Marieann Brill, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5154, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is responsible for protecting the public
health by assuring the safety, efficacy, and security of human and
veterinary drugs, biological products, medical devices, our Nation's
food supply, cosmetics, and products that emit radiation. FDA also has
responsibility for regulating the manufacturing, marketing, and
distribution of tobacco products to protect the public health and to
reduce tobacco use by minors.
    FDA is establishing a public docket, Docket No. FDA-2020-N-1153, to
receive input on post-marketing pediatric-focused safety reviews of
products posted between September 23, 2019, and September 1, 2020,
available on FDA's website at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm but
not presented at the September 15, 2020, PAC meeting. FDA welcomes
comments by members of the PAC, as mandated by the Best Pharmaceuticals
for Children Act (Pub. L. 107-109) and the Pediatric Research Equity
Act of 2003 (Pub. L. 108-155), interested parties (such as academic
researchers, regulated industries,

consortia, and patient groups), and the general public. The docket
number is FDA-2020-N-1153. The docket will open on September 1, 2020,
and remain open until September 22, 2020. The post-marketing pediatric-
focused safety reviews are for the following products from the
following Centers at FDA:

Center for Biologics Evaluation and Research

1. AFSTYLA (antihemophilic factor (recombinant), single chain)
2. EPICEL (cultured epidermal autografts)
3. FLUCELVAX QUADRIVALENT (influenza vaccine)
4. FLUCELVAX (influenza vaccine)
5. FLULAVAL (influenza vaccine)
6. FLULAVAL QUADRIVALENT (influenza vaccine)
7. HIBERIX (Haemophilus b conjugate vaccine (tetanus toxoid conjugate))
8. KOVALTRY (antihemophilic factor (recombinant))
9. QPAN H5N1 Vaccine (Influenza A (H5N1) virus monovalent vaccine,
adjuvanted)

Center for Drug Evaluation and Research

1. BUTRANS (buprenorphine transdermal system)
2. CANASA (mesalamine suppositories for rectal use)
3. DESCOVY (emtricitabine and tenofovir alafenamide)
4. DRAXIMAGE DTPA (technetium TC-99m pentetate kit) injection and
inhalation
5. DYSPORT (abobotulinumtoxinA)
6. GENVOYA (elvitegravir, cobicistat, emtricitabine, and tenofovir
alafenamide) oral tablets
7. LUMASON (sulfur hexafluoride lipid-type A microspheres) injectable
suspension
8. LUMIFY (brimonidine tartrate) OTC
9. LUZU (luliconazole) cream, 1%
10. OMIDRIA (phenylephrine and ketorolac intraocular solution)
11. SENSIPAR (cinacalcet)
12. STELARA (ustekinumab) injection
13. SYMFI LO (efavirenz 400 milligram (mg) + lamivudine 300 mg +
tenofovir disoproxil fumarate 300 mg) and SYMFI (efavirenz 600 mg +
lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg)
14. TRIUMEQ (abacavir, dolutegravir, and lamivudine)
15. XEPI (ozenoxacin)

Center for Devices and Radiological Health

1. CONTEGRA PULMONARY VALVED CONDUIT (Humanitarian Device Exemption
(HDE))
2. ELANA SURGICAL KIT (HDE)
3. ENTERRA THERAPY SYSTEM (HDE)
4. LIPOSORBER LA-15 SYSTEM (HDE)
5. MEDTRONIC ACTIVA DYSTONIA THERAPY (HDE)
6. PLEXIMMUNE IN-VITRO DIAGNOSTIC TEST (HDE)
7. PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (HDE)

    Dated: August 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19385 Filed 9-1-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Rules and Regulations]
[Pages 14647-14649]
[FR Doc No: 2013-04632]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1164; Directorate Identifier 2012-NM-075-AD;
Amendment 39-17370; AD 2013-04-12]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Airbus Model A310-204, -222, -304, -322, and -324 airplanes. This AD
was prompted by the manufacturer re-classifying slat extension
eccentric bolts as principle structural elements (PSE) with replacement
due at or before newly calculated fatigue life limits. This AD requires
replacing slat extension eccentric bolts and associated washers with
new slat extension eccentric bolts and washers. We are issuing this AD
to prevent fatigue cracking, which could result in the loss of
structural integrity of the airplane.

DATES: This AD becomes effective April 11, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 11,
2013.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on November 19, 2012
(77 FR 69391). That NPRM proposed to correct an unsafe condition for
the specified products. The Mandatory Continuing Airworthiness
Information (MCAI) states:

    Slat extension eccentric bolts have been reclassified as
Principal Structural Elements (PSE). As a result, associated fatigue
lives will be published in the Airbus A310 Airworthiness Limitation
Section (ALS) Part 1 and bolts must be replaced at or before their
calculated fatigue lives.
    Failure to replace the bolts within the new fatigue life limits
constitutes an unsafe condition.
    For the reasons explained above, this [European Aviation Safety
Agency (EASA)] AD requires:

--for A310-300 aeroplanes, the replacement of slat extension
eccentric bolts, Part Number (P/N) A57844015200, with slat extension
eccentric bolts P/N A57844015204 at the slat 2 tracks 4 and 7 and
slat 3 track 8 positions on both Left Hand (LH) and Right Hand (RH)
wings, and
--for A310-300 and A310-200 aeroplanes that incorporate Airbus
modification 04809, the replacement of slat extension eccentric
bolts, P/N A57843624200 and associated washers P/N A57844016200,
with slat extension eccentric bolts P/N A57843624202 and washers P/N
A57844391200 at the slat 2 track 5 position, on both LH and RH
wings.

    You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (77 FR 69391, November 19,
2012) or on the determination of the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed--except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (77 FR 69391, November 19, 2012) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (77 FR 69391, November 19, 2012).

Costs of Compliance

    We estimate that this AD will affect 1 product of U.S. registry. We
also estimate that it will take about 9 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Required parts will cost about $25,250 per
product. Where the service information lists required parts costs that
are covered under warranty, we have assumed that there will be no
charge for these parts. As we do not control warranty coverage for
affected parties, some parties may incur costs higher than estimated
here. Based on these figures, we estimate the cost of this AD to the
U.S. operators to be $26,015, or $26,015 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (77 FR 69391, November 19,
2012), the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2013-04-12 Airbus: Amendment 39-17370. Docket No. FAA-2012-1164;
Directorate Identifier 2012-NM-075-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective April 11,
2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A310-204, -222, -304, -322, and
-324 airplanes, certificated in any category, having received in
production Airbus modification 04809 without Airbus modification
06243 or 13596.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Reason

    This AD was prompted by the manufacturer re-classifying slat
extension eccentric bolts as principle structural elements (PSE)
with replacement due at or before newly calculated fatigue life
limits. We are issuing this AD to prevent fatigue cracking, which
could result in the loss of structural integrity of the airplane.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Compliance Times

    At the applicable time specified in paragraphs (g)(1), (g)(2),
or (g)(3) of this AD: Do the replacements specified in paragraphs
(h)(1) and (h)(2) of this AD, as applicable. For the purposes of
this AD, to establish the average flight time (AFT), take the
accumulated flight time (counted from the take-off up to the
landing) and divide it by the number of accumulated flight cycles.
This gives the AFT per flight cycle.
    (1) For Model A310-304, -322, and -324 airplanes operated with
an AFT of less than 4 hours: Before the accumulation of 66,000 total
flight hours or 40,000 total flight cycles, whichever occurs first.
    (2) For Model A310-304, -322, and -324 airplanes operated with
an AFT of 4 hours or more: Before the accumulation of 66,000 total
flight hours or 31,400 total flight cycles, whichever occurs first.
    (3) For Model A310-204 and -222 airplanes with Airbus
modification 04809: Before the accumulation of 71,800 total flight
hours or 35,900 total flight cycles, whichever occurs first.

(h) Replacement of Slat Extension Eccentric Bolt and Hardware on Both
Wings

    (1) For Model A310-304, -322, and -324 airplanes: Replace the
slat extension eccentric bolts, part number (P/N) A57844015200, at
the slat 2, tracks 4 and 7, and slat 3, track 8 positions with new
slat eccentric extension bolts, P/N A57844015204, in accordance with
the Accomplishment Instructions of Airbus Mandatory Service Bulletin
A310-57-2100, Revision 01, dated February 3, 2012.
    (2) For Model A310-304, -322, and -324 airplanes, and Model
A310-204 and -222 airplanes that have incorporated Airbus
modification 04809: Replace the slat extension eccentric bolts, P/N
A57843624200, at the slat 2, track 5, position with new slat
extension eccentric bolts, P/N A57843624202; and replace the
associated washers of eccentric bolts, P/N A57844016200, at the slat
2, track 5, position with washers, P/N A57844391200; in accordance
with the Accomplishment Instructions of Airbus Mandatory Service
Bulletin A310-57-2100, Revision 01, dated February 3, 2012.

(i) Parts Installation Prohibition

    After the modification of the airplane with the replacement of
slat extension eccentric bolts and associated hardware required by
paragraphs (g) and (h) of this AD, no person may install any slat
extension eccentric bolt, P/N A57844015200 or P/N A57843624200, with
associated washer P/N A57844016200, on that airplane.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Dan Rodina,
Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may
be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(k) Related Information

    Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2012-0042, dated April 10, 2012; and Airbus Mandatory
Service Bulletin A310-57-2100, Revision 01, dated February 3, 2012;
for related information.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Airbus Mandatory Service Bulletin A310-57-2100, Revision 01,
dated February 3, 2012.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Airbus SAS--EAW (Airworthiness Office), 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (4) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on February 21, 2013.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-04632 Filed 3-6-13; 8:45 am]
BILLING CODE 4910-13-P