[Federal Register: March 3, 2008 (Volume 73, Number 42)]
[Notices]
[Page 11420]
[DOCID:fr03mr08-59]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0118]

Draft Guidance for Industry on Diabetes Mellitus: Developing
Drugs and Therapeutic Biologics for Treatment and Prevention;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Diabetes
Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and
Prevention.'' The draft guidance provides recommendations for industry
for developing drugs and therapeutic biologics for the prevention and
treatment of diabetes mellitus. Because diabetes mellitus has reached
epidemic proportions in the United States, FDA recognizes the need for
new products that can be used as part of a comprehensive treatment
strategy in the treatment and prevention of diabetes. In addition to
the draft guidance, FDA plans to convene a public advisory committee
meeting to specifically discuss new approaches for the development of
products for the treatment of diabetes, with particular emphasis on the
design and implementation of studies to assess long-term cardiovascular
risks and benefits of these new products. FDA plans to announce the
meeting date in a future issue of the Federal Register.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by May 2, 2008.

ADDRESSES:  Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to
assist that office in processing your requests. Submit written comments
on the draft guidance to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments to http://www.regulations.gov. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ilan Irony, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, rm. 3100, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Diabetes Mellitus: Developing Drugs and Therapeutic
Biologics for Treatment and Prevention.'' Although a number of drugs
are available for the treatment of type 1 and type 2 diabetes, many
patients remain inadequately controlled, and thus are exposed to a
higher risk of long-term complications. This draft guidance provides
recommendations on the following topics related to the treatment of
type 1 and type 2 diabetes mellitus:
     Diabetes-specific preclinical studies;
     Different study designs in different phases of drug
development for both type 1 and type 2 diabetes;
     Study endpoints in the assessment of pharmacokinetic/
pharmacodynamic profiles and for efficacy and safety assessment in
treating patients with diabetes;
     Study population considerations in different phases of
development;
     Sample sizes;
     Study duration; and
     Specific statistical issues related to development of
drugs and biologics intended for the treatment of diabetes.
    The draft guidance also provides recommendations regarding the
development of products for the prevention of both type 1 and type 2
diabetes.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the
treatment and prevention of diabetes mellitus. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://
www.fda.gov/ohrms/dockets/default.htm.

    Dated: February 25, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-3974 Filed 2-29-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 54 (Tuesday, March 23, 2021)]
[Notices]
[Pages 15478-15482]
[FR Doc No: 2021-05927]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2021-0068; FRL-10021-62]

Certain New Chemicals; Receipt and Status Information for
February 2021

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 02/01/
2021 to 02/28/2021.

DATES: Comments identified by the specific case number provided in this
document must be received on or before April 22, 2021.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2021-0068 and the specific case number for the
chemical substance related to your comment, by using the Federal
eRulemaking Portal at 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.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Jim Rahai, Project Management
and Operations Division (7407M), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

What action is the Agency taking?

    This document provides the receipt and status reports for the
period from 02/01/2021 to 02/28/2021. 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 please go to: https://www.epa.gov/tsca-inventory.
    Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN or SNUN, as appropriate,
before initiating the activity. EPA will review the notice, make a risk
determination on the chemical substance or significant new use, and
take appropriate action as described in TSCA section 5(a)(3).
    TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture or
process a new chemical substance, or a chemical substance subject to a
significant new use rule (SNUR) issued under TSCA section 5(a)(2), for
``test marketing'' purposes, upon a showing that the manufacture,
processing, distribution in commerce, use, and disposal of the chemical
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: 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 PMN/SNUN/MCANs that have passed an initial screening by EPA
during this period, Table I provides the following information (to the
extent that such information is not subject to a CBI claim) on the
notices screened by EPA during this period: The EPA case number
assigned to the notice that indicates whether the submission is an
initial submission, or an amendment, a notation of which version was
received, the date the notice was received by EPA, the submitting
manufacturer (i.e., domestic producer or importer), the potential uses
identified by the manufacturer in the notice, and the chemical
substance identity.
    As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that this information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI. Submissions which are initial submissions
will not have a letter following the case number. Submissions which are
amendments to previous submissions will have a case number followed by
the letter ``A'' (e.g., P-18-1234A). The version column designates
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some
cases, an initial submission is not numbered as version 1; this is
because earlier version(s) were rejected as incomplete or invalid
submissions. Note also that future versions of the following tables may
adjust slightly as the Agency works to automate population of the data
in the tables.

                                            Table I--PMN/SNUN/MCANs Approved * From 02/01/2021 to 02/28/2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   Received
               Case No.                 Version      date            Manufacturer                    Use                      Chemical substance
--------------------------------------------------------------------------------------------------------------------------------------------------------
J-21-0005.............................        3   01/14/2021  CBI......................  (G) Chemical production....  (G) Modified Saccharomyces
                                                                                cerevisiae enhanced ethanol
                                                                                yield.
J-21-0006.............................        3   01/14/2021  CBI......................  (G) Chemical production....  (G) Modified Saccharomyces
                                                                                cerevisiae enhanced ethanol
                                                                                yield.
P-18-0128A............................        5   02/22/2021  CBI......................  (G) Surface modifier.......  (S) Inulin, 2-hydroxy-3-
                                                                                (trimethylammonio)propyl ether,
                                                                                chloride.
P-18-0135A............................        5   02/03/2021  CBI......................  (G) Ingredient for           (S) 1,2-Decanediol.
                                                                                household products.
P-18-0256A............................        5   02/10/2021  CBI......................  (G) Chemical Intermediate..  (S) Undecanol, branched.
P-18-0273A............................        7   02/25/2021  CBI......................  (G) Used in polymer          (S) 1,4-Cyclohexanedicarboxylic
                                                                                manufacturing.               acid, 1,4-bis(2-ethylhexyl)
                                                                                ester.
P-18-0289A............................        9   02/15/2021  Guard Products...........  (G) Gas scrubbing, landfill  (G) 2-
                                                                                deoderizing.                 (2(methylcaboxymonocyclic)amino)e
                                                                                thoxy)-alcohol.
P-18-0289A............................       10   02/15/2021  Guard Products...........  (G) Gas scrubbing, landfill  (G) 2-
                                                                                deoderizing.                 (2(methylcaboxymonocyclic)amino)e
                                                                                thoxy)-alcohol.
P-18-0290A............................        9   02/15/2021  Guard Products...........  (G) Gas scrubbing,           (G) Carbomonocylic-oxazolidine.
                                                                                wastewater deodorizing.
P-18-0290A............................       10   02/15/2021  Guard Products...........  (G) Gas scrubbing,           (G) Carbomonocylic-oxazolidine.
                                                                                wastewater deodorizing.
P-18-0293A............................        8   02/02/2021  Sirrus, Inc..............  (S) Intermediate: Monomer    (S) Propanedioic acid, 2-methylene-
                                                                                used as a chemical, in the   , 1,3-dihexyl ester.
                                                                                manufacture of polymers,
                                                                                Adhesives: Monomer used in
                                                                                the manufacture
                                                                                (formulation) of
                                                                                adhesives, Coatings:
                                                                                Monomer used in the
                                                                                manufacture of industrial
                                                                                coatings.
P-18-0293A............................        9   02/02/2021  Sirrus, Inc..............  (S) Intermediate: Monomer    (S) Propanedioic acid, 2-methylene-
                                                                                used as a chemical, in the   , 1,3-dihexyl ester.
                                                                                manufacture of polymers,
                                                                                Adhesives: Monomer used in
                                                                                the manufacture
                                                                                (formulation) of
                                                                                adhesives, Coatings:
                                                                                Monomer used in the
                                                                                manufacture of industrial
                                                                                coatings.
P-18-0294A............................        8   02/02/2021  Sirrus, Inc..............  (S) Intermediate: Monomer    (S) Propanedioic acid, 2-methylene-
                                                                                for use in emulsion          , 1,3-dicyclohexyl ester.
                                                                                polymers, Adhesives:
                                                                                Monomer for use in
                                                                                formulated industrial
                                                                                adhesives, Coatings:
                                                                                Monomer for use in
                                                                                formulated industrial
                                                                                coatings.

P-18-0294A............................        9   02/02/2021  Sirrus, Inc..............  (S) Intermediate: Monomer    (S) Propanedioic acid, 2-methylene-
                                                                                used as a chemical, in the   , 1,3-dicyclohexyl ester.
                                                                                manufacture of polymers,
                                                                                Adhesives: Monomer used in
                                                                                the manufacture
                                                                                (formulation) of
                                                                                adhesives, Coatings:
                                                                                Monomer used in the
                                                                                manufacture of industrial
                                                                                coatings.
P-18-0301A............................        3   02/02/2021  CBI......................  (G) Coating component......  (G) Alkanedioic acid, polymer with
                                                                                cycloalkyl dimethanol, alkyl and
                                                                                cycloalkyl diisocyanates,
                                                                                dimethyl-alkanediol,
                                                                                dihydroxyalkanoic acid
                                                                                methylenebis[isocyanatocyclohexan
                                                                                e, hydroxyethyl acrylate- and
                                                                                polyalkyl glycol monoalkyl ether
                                                                                blocked.
P-18-0383A............................        5   02/02/2021  CBI......................  (G) Coatings and inks for    (G) Dialkyl-alkanediamine, polymer
                                                                                commercial use.              with [(oxo-alkenyl)oxy]poly(oxy-
                                                                                alkanediyl)ether with
                                                                                bis(hydroxyalkyl)-alkanediol.
P-19-0122A............................        4   02/10/2021  CBI......................  (G) Reactant monomer in a    (G) 2-propenoic acid, 2-
                                                                                polymer for industrial use.  (hydrogenated animal-based
                                                                                nitrogen-substituted) ethyl
                                                                                ester.
P-19-0160A............................        3   02/09/2021  CBI......................  (S) Component of a UV        (G) Alkanesulfonic acid, 2-[(2-
                                                                                curable printing ink.        aminoethyl)heteroatom-
                                                                                substituted]-, sodium salt (1:1),
                                                                                polymer with alpha-[2,2-
                                                                                bis(hydroxymethyl)butyl]-omega-
                                                                                methoxypoly(oxy-1,2-ethanediyl)
                                                                                and 1,1'-methylenebis[4-
                                                                                isocyanatocyclohexane], acrylic
                                                                                acid-dipenthaerythritol reaction
                                                                                products- and polypropylene
                                                                                glycol ether with pentaerythritol
                                                                                (4:1) triacrylate-blocked.
P-20-0071A............................        9   02/18/2021  CBI......................  (G) Colorant...............  (G) Salt of 2-Naphthalenesulfonic
                                                                                acid, hydroxy [(methoxy-methyl-4-
                                                                                sulfophenyl)diazenyl].
P-20-0083A............................        3   02/10/2021  CBI......................  (G) Reactant monomer in a    (G) 2-propenoic acid, nitrogen-
                                                                                polymer for industrial use.  substituted alkyl, N-C16-18-acyl
                                                                                derivs.
P-20-0097A............................        5   02/19/2021  Nelson Brothers, LLC.....  (S) The PMN substance will   (G) Butanedioic acid,
                                                                                be used as an emulsifier     monopolyisobutylene derivs.,
                                                                                for applications in          mixed dihydroxyalkyl and
                                                                                explosives.                  hydroxyalkoxyalkyl diesters.
P-20-0110A............................        2   02/02/2021  Clariant Corporation.....  (S) Base oil additive for    (G) Oxirane, 2-methyl-, polymer
                                                                                lubricants and greases.      with oxirane, (alkoxyalkoxy)alkyl
                                                                                alkyl ether.
P-20-0124A............................        2   02/05/2021  CBI......................  (G) Additive in Household    (S) 5-octen-4-ol, 3,5-dimethyl-,
                                                                                consumer products.           (5E)-.
P-20-0126A............................        2   02/05/2021  CBI......................  (G) Additive in household    (S) 4-Decenal, 5,9-dimethyl-.
                                                                                consumer products.
P-20-0132A............................        2   02/08/2021  Designer Molecules, Inc..  (G) Adhesive component.....  (S) 1H-Pyrrole-2,5-dione, 3-methyl-
                                                                                , 1,1'-C36-alkylenebis-.
P-20-0148A............................        3   01/29/2021  Solugen, Inc.............  (G) Additive for consumer,   (G) Hydroxyalkanoic acid, salt,
                                                                                industrial, and commercial   oxidized.
                                                                                uses.
P-20-0148A............................        4   02/08/2021  Solugen, Inc.............  (G) Additive for consumer,   (G) Hydroxyalkanoic acid, salt,
                                                                                industrial, and commercial   oxidized.
                                                                                uses.
P-20-0148A............................        5   02/10/2021  Solugen, Inc.............  (G) Additive for consumer,   (G) Hydroxyalkanoic acid, salt,
                                                                                industrial, and commercial   oxidized.
                                                                                uses.
P-20-0149A............................        3   01/29/2021  Solugen, Inc.............  (G) Additive for consumer,   (G) Hydroxyalkanoic acid, salt,
                                                                                industrial, and commercial   oxidized.
                                                                                uses.
P-20-0149A............................        4   02/08/2021  Solugen, Inc.............  (G) Additive for consumer,   (G) Hydroxyalkanoic acid, salt,
                                                                                industrial, and commercial   oxidized.
                                                                                uses.
P-20-0149A............................        5   02/10/2021  Solugen, Inc.............  (G) Additive for consumer,   (G) Hydroxyalkanoic acid, salt,
                                                                                industrial, and commercial   oxidized.
                                                                                uses.
P-20-0150A............................        3   01/29/2021  Solugen, Inc.............  (G) Additive for consumer,   (G) Hydroxyalkanoic acid, salt,
                                                                                industrial, and commercial   oxidized.
                                                                                uses.
P-20-0150A............................        4   02/08/2021  Solugen, Inc.............  (G) Additive for consumer,   (G) Hydroxyalkanoic acid, salt,
                                                                                industrial, and commercial   oxidized.
                                                                                uses.
P-20-0150A............................        5   02/10/2021  Solugen, Inc.............  (G) Additive for consumer,   (G) Hydroxyalkanoic acid, salt,
                                                                                industrial, and commercial   oxidized.
                                                                                uses.
P-20-0151A............................        3   01/29/2021  Solugen, Inc.............  (G) Additive for consumer,   (G) Hydroxyalkanoic acid, salt,
                                                                                industrial, and commercial   oxidized.
                                                                                uses.
P-20-0151A............................        4   02/08/2021  Solugen, Inc.............  (G) Additive for consumer,   (G) Hydroxyalkanoic acid, salt,
                                                                                industrial, and commercial   oxidized.
                                                                                uses.
P-20-0151A............................        5   02/10/2021  Solugen, Inc.............  (G) Additive for consumer,   (G) Hydroxyalkanoic acid, salt,
                                                                                industrial, and commercial   oxidized.
                                                                                uses.
P-20-0167A............................        4   02/11/2021  W.R. Grace & Co.--Conn...  (G) Catalyst...............  (G) Phenylene, alkyl and
                                                                                polycarbomonocycle substituted,
                                                                                1,2-dicarboxylate.
P-20-0168A............................        6   02/10/2021  CBI......................  (S) Lubricating additives    (G) Polyolefin polyamine
                                                                                for engine oils,             succinimide, carbopolycycle
                                                                                transmission and hydraulic   alkoxylated.
                                                                                fluid and gear oil
                                                                                applications.
P-20-0183A............................        3   02/10/2021  CBI......................  (G) Intermediate...........  (G) Aryl ether epoxide,
                                                                                homopolymer, ether with
                                                                                alkanolamine.
P-21-0015A............................        2   01/28/2021  Designer Molecules, Inc..  (S) As a raw material in a   (S) Amines, C36-alkylenedi-,
                                                                                Temporary Bonding Adhesive   polymers with 5,5'-[(1-
                                                                                formulation.                 methylethylidene)bis(4,1-
                                                                                phenyleneoxy)]bis[1,3-
                                                                                isobenzofurandione] and 4,4'-
                                                                                [2,2,2-trifluoro-1-
                                                                                (trifluoromethyl)ethylidene]bis[2-
                                                                                aminophenol].
P-21-0036.............................        2   02/04/2021  CBI......................  (G) Additive in Household    (S) 5-Hexen-2-one, 1-
                                                                                consumer products.           bicyclo[2.2.1]hept-2-yl-.
P-21-0039A............................        2   02/03/2021  Sinova Specialties, Inc..  (S) Part of a series of      (S) 1,2,4,5-
                                                                                chemicals used as            Benzenetetracarboxamide, N1, N2,
                                                                                viscosity modifiers in       N4, N5-tetrahexyl-.
                                                                                commercial and consumer
                                                                                engine oil.

P-21-0040A............................        2   02/03/2021  Sinova Specialties, Inc..  (S) Part of a series of      (S) 1,2,4,5-
                                                                                chemicals used as            Benzenetetracarboxamide,
                                                                                viscosity modifiers in       N1,N2,N4,N5-tetraoctyl-.
                                                                                commercial and consumer
                                                                                engine oil.
P-21-0041A............................        2   02/03/2021  Sinova Specialties, Inc..  (S) Part of a series of      (S) 1,2,4,5-
                                                                                chemicals used as            Benzenetetracarboxamide,
                                                                                viscosity modifiers in       N1,N2,N4,N5-tetradodecyl-.
                                                                                commercial and consumer
                                                                                engine oil.
P-21-0051A............................        3   02/15/2021  Designer Molecules, Inc..  (G) Resin component of an    (S) Fatty Acids, C18-unsatd.,
                                                                                adhesive formulation.        dimers, hydrogenated, polymers
                                                                                with 2-hydroxyethyl-terminated
                                                                                hydrogenated polybutadiene,
                                                                                bis(2,5-dihydro-2,5-dioxo-1H-
                                                                                pyrrole-1-hexanoate).
P-21-0055.............................        2   02/01/2021  Hexion, Inc..............  (G) adhesive used for        (G) fatty acids, reaction products
                                                                                coating formulation.         with polyamine-polyacid polymer
                                                                                and fatty acid.
P-21-0055A............................        3   02/04/2021  Hexion, Inc..............  (G) adhesive used for        (G) fatty acids, reaction products
                                                                                coating formulation.         with polyamine-polyacid polymer
                                                                                and fatty acid.
P-21-0055A............................        4   02/23/2021  Hexion, Inc..............  (G) adhesive used for        (G) fatty acids, reaction products
                                                                                coating formulation.         with polyamine-polyacid polymer
                                                                                and fatty acid.
P-21-0059.............................        2   02/17/2021  CBI......................  (G) Stabilizer.............  (S) Methanesulfonic acid,1,1,1-
                                                                                trifluoro-, ytterbium(3+) salt
                                                                                (3:1).
P-21-0060A............................        3   02/03/2021  CBI......................  (G) Isolated intermediate..  (G) Bisphenol A epichlorohydrin
                                                                                polymer with alkylpolyalkene-
                                                                                polyarylene-
                                                                                hydroxypolyoxyalkyldiyl reaction
                                                                                products with alkylalkylidene-
                                                                                alkylalkylidene-aminoalkyl-
                                                                                alkanepolyamine and
                                                                                alkylaminoalkanol.
P-21-0061A............................        3   02/03/2021  CBI......................  (G) Component in coatings..  (G) Sulfur based acid, compds.
                                                                                with modified bisphenol A-
                                                                                epichlorohydrin-polyalkylene
                                                                                polyol ether with bisphenol A
                                                                                polymer-N-dialkylalkylidene-N-
                                                                                (dialkylalklyidene)aminoalkyl-
                                                                                alkanepolyamine-alkylaminoalkanol
                                                                                reaction products.
P-21-0062A............................        3   02/03/2021  CBI......................  (G) Component in coatings..  (G) Substituted-alkanoic acid,
                                                                                compds. with modified bisphenol A-
                                                                                epichlorohydrin-polyalkylene
                                                                                polyol ether with bisphenol A
                                                                                polymer-N-dialkylalkylidene-N-
                                                                                dialkylalkylideneaminoalkyl-
                                                                                alkanepolyamine-alkylaminoalkanol
                                                                                reaction products.
P-21-0066.............................        4   02/08/2021  L & L Products...........  (S) Blended or stand alone,  (G) 1,2-alcandiol, 3-aryloxy, mono
                                                                                epoxy curative (hardener)    phosphate ester.
                                                                                and foaming agent when
                                                                                blended with certain
                                                                                ingredients.
P-21-0074A............................        2   02/15/2021  Designer Molecules, Inc..  (G) Resin component of an    (S) 1,3-Butadiene, homopolymer,
                                                                                adhesive formulation.        hydrogenated, 2-(ethenyloxy)ethyl-
                                                                                terminated.
P-21-0075A............................        2   02/04/2021  Allnex USA, Inc..........  (S) Coating Resin..........  (G) Alkanoic acid, hydroxy-
                                                                                (hydroxyalkyl)-alkyl-, polymer
                                                                                with alpha-[(hydroxyalkyl)alkyl]-
                                                                                omega-alkoxypoly(oxy-alkanediyl),
                                                                                dialkyl carbonate, alkanediol,
                                                                                alkylene[isocyanato-
                                                                                carbomonocycle] and
                                                                                [oxybis(alkylene)]bis[alkyl-
                                                                                alkanediole] alkenoate, compd.
                                                                                with dialkyalkanamine.
P-21-0076.............................        2   02/09/2021  CBI......................  (S) Additive for fluids      (G) Alcohols, C16-18 and C18-
                                                                                used in oil drilling         unsatd., reaction products with
                                                                                operations.                  subsstituted alkyloxirane and
                                                                                alkyl acid.
P-21-0077.............................        1   02/02/2021  Rahn USA Corp............  (G) Battery additive.......  (S) Tinci_PMN3.
P-21-0078.............................        1   02/02/2021  Pinova, Inc..............  (S) Tackifying additive      (G) Phenol, polymer with alkyl-
                                                                                used in tire manufacture;    (alkylalkylenyl)cyclohexene,
                                                                                Tackifying additive used     mixed dialkylcyclohexadienes,
                                                                                in hot melt adhesive         mixed alkyl-
                                                                                applications.                (alkylalkylidene)cyclohexenes and
                                                                                3,7,7-trimethylbicyclo[4.1.0]hept-
                                                                                3-ene.
P-21-0078A............................        2   02/23/2021  Pinova, Inc..............  (S) Tackifying additive      (G) Phenol, polymer with alkyl-
                                                                                used in tire manufacture;    (alkylalkylenyl)cyclohexene,
                                                                                Tackifying additive used     mixed dialkylcyclohexadienes,
                                                                                in hot melt adhesive         mixed alkyl-
                                                                                applications.                (alkylalkylidene)cyclohexenes and
                                                                                3,7,7-trimethylbicyclo[4.1.0]hept-
                                                                                3-ene.
P-21-0079.............................        1   02/04/2021  CBI......................  (G) Additive in Household    (S) 13-Oxabicyclo[10.1.0]trideca-
                                                                                consumer products.           4,8-diene, (4E)-.
P-21-0080.............................        2   02/10/2021  Allnex USA, Inc..........  (S) Binder for UV Curable    (G) Alkanedioic acid, polymers
                                                                                Coating Resin.               with alkanoic acid-
                                                                                dipentaerythritol reaction
                                                                                products, alkanedioc acid
                                                                                dihydrazide, hydroxy-
                                                                                (hydroxyalkyl)-alkylalkanoic
                                                                                acid, isocyanato-
                                                                                (isocyanatoalkyl)-alkyl
                                                                                substituted carbomonocycle,
                                                                                dialkylalkanediol and polyakylene
                                                                                glycol(hydroxyalkyl)alkyl aklyl
                                                                                ether.
P-21-0081.............................        2   02/11/2021  CBI......................  (G) Additive in Household    (S) 4-Pentenal, 5-cyclohexyl-2,4-
                                                                                consumer products.           dimethyl-, (4E)-.
P-21-0082.............................        1   02/05/2021  CBI......................  (G) Additive in household    (S) 1-Decen-4-yne.
                                                                                consumer products.
P-21-0083.............................        2   02/10/2021  Allnex, USA Inc..........  (S) UV Curable resin.......  (G) Alkenoic acid, reaction
                                                                                products with pentaerythritol,
                                                                                polymers with diisocyanatoalkane
                                                                                and heteromonocyle homopolymer
                                                                                esters with alkanoic acid-
                                                                                pentaerythritol reaction
                                                                                products.
P-21-0084.............................        1   02/08/2021  CBI......................  (G) Chemical intermediate..  (G) Carbopolycycle octa-alkene,
                                                                                halo.
P-21-0085.............................        1   02/08/2021  CBI......................  (G) Used as an additive in   (S) 1-Propanethiol, 3-
                                                                                the manufacture of tires     (triethoxysilyl)-, reaction
                                                                                to improve performance.      products with polybutadiene.
P-21-0085A............................        2   02/25/2021  CBI......................  (G) Used as an additive in   (S) 1-Propanethiol, 3-
                                                                                the manufacture of tires     (triethoxysilyl)-, reaction
                                                                                to improve performance.      products with polybutadiene.
P-21-0089.............................        3   02/25/2021  CBI......................  (G) Emulsifier.............  (G) Lignin, modified, reaction
                                                                                products with alkylamine by-
                                                                                products, hydrochlorides.

P-21-0093.............................        2   02/19/2021  CBI......................  (G) Antiwear additive for    (G) Phosphonic acid, dimethyl
                                                                                lubricants.                  ester, reaction products with
                                                                                alkyl-alkyl-alkanediol and
                                                                                alkanediol.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required information and documents have been provided
  with the submission prior to the start of the 90 day review period, and in no way reflects the final status of a complete submission review.

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

                             Table II--NOCs Approved * From 02/01/2021 to 02/28/2021
----------------------------------------------------------------------------------------------------------------
                                                                     If amendment, type of
       Case No.            Received date        Commencement date          amendment         Chemical substance
----------------------------------------------------------------------------------------------------------------
J-19-0022............  02/02/2021...........  01/08/2021...........  N....................  (G) Saccharomyces
                                                                                cerevisiae, strain
                                                                                cbi.
P-07-0004............  02/09/2021...........  02/06/2021...........  N....................  (G) Fatty acids, c16-
                                                                                18 and c18
                                                                                unsaturated, esters
                                                                                with mixed diols &
                                                                                triols.
P-15-0017............  02/04/2021...........  06/16/2017...........  N....................  (G) Iron
                                                                                alkylenediaminehydr
                                                                                oxy sulfophonic
                                                                                acid.
P-17-0360............  02/01/2021...........  02/01/2021...........  N....................  (S) 2-Propanol, 1-
                                                                                amino-,compd.
                                                                                with.alpha.-sulfo-
                                                                                .omega.-
                                                                                (octyloxy)poly(oxy-
                                                                                1,2-
                                                                                ethanediyl)(1:1).
                                                                                (S) 2-propanol, 1-
                                                                                amino-,compd. with
                                                                                .alpha.-sulfo-
                                                                                .omega.-
                                                                                (decyloxy)poly(oxy-
                                                                                1,2-
                                                                                ethanediyl)(1:1).
P-17-0364............  02/05/2021...........  01/11/2021...........  N....................  (G) Dicyloalkyl-
                                                                                alkane-di-
                                                                                isocyanate
                                                                                homopolymer, alkyl
                                                                                alcohol and
                                                                                polyalkyl glycol
                                                                                mono-alkyl-ether-
                                                                                blocked.
P-18-0175............  02/16/2021...........  02/14/2021...........  N....................  (S) Formaldehyde,
                                                                                polymer with 4-(1,1-
                                                                                dimethylethyl)pheno
                                                                                l and phenol, bu
                                                                                ether.
P-19-0081............  02/11/2021...........  02/07/2021...........  N....................  (G) 2-propenoic
                                                                                acid, ethyl ester,
                                                                                reaction products
                                                                                with o,o-
                                                                                bis(polyalkylalkyl)
                                                                                hydrogen
                                                                                phosphorodithioate,
                                                                                o,o-dialkyl
                                                                                hydrogen
                                                                                phosphorodithioate
                                                                                and propylene
                                                                                oxide.
P-19-0147............  02/02/2021...........  01/29/2021...........  N....................  (G) Alkoxylated buty
                                                                                alkyl ester.
P-21-0012............  02/16/2021...........  02/05/2021...........  N....................  (G)
                                                                                Multialkylbicycloal
                                                                                kenyl substituted
                                                                                propanenitrile.
----------------------------------------------------------------------------------------------------------------
* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
  information and documents have been provided with the submission.

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

                       Table III--Test Information Received From 02/01/2021 to 02/28/2021
----------------------------------------------------------------------------------------------------------------
              Case No.                 Received date    Type of test information         Chemical substance
----------------------------------------------------------------------------------------------------------------
P-16-0543...........................      02/23/2021  Exposure Monitoring Report    (G) Halogenophosphoric acid
                                                       January 2021.                 metal salt.
----------------------------------------------------------------------------------------------------------------

    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: March 17, 2021.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2021-05927 Filed 3-22-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18592-18593]
[FR Doc No: 2014-07286]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71821; File No. SR-NYSE-2014-17]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Extending a Pilot Program Related to Rule 128, Entitled ``Clearly
Erroneous Executions For NYSE Equities''

March 27, 2014.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on March 26, 2014, New York Stock Exchange LLC (``NYSE'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to extend a pilot program related to Rule
128, entitled ``Clearly Erroneous Executions For NYSE Equities.'' The
text of the proposed rule change is available on the Exchange's Web
site at www.nyse.com, at the principal office of the Exchange, and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of this filing is to extend the effectiveness of the
Exchange's current rule applicable to Clearly Erroneous Executions.
Portions of Rule 128, explained in further detail below, are currently
operating as a pilot program set to expire on April 8, 2014.\4\ The
Exchange proposes to extend the pilot program to coincide with the
pilot period for the Plan to Address Extraordinary Market Volatility
Pursuant to Rule 608 of Regulation NMS under the Act (the ``Limit Up-
Limit Down Plan'' or the ``Plan''), including any extensions to the
pilot period for the Plan.\5\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 70519 (September 26,
2013), 78 FR 60969 (October 2, 2013) (SR-NYSE-2013-65).
    \5\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012) (the ``Limit Up-Limit Down
Release'').
---------------------------------------------------------------------------

    On September 10, 2010, the Commission approved, on a pilot basis,
changes to Rule 128 to provide for uniform treatment: (1) Of clearly
erroneous execution reviews in multi-stock events involving twenty or
more securities; and (2) in the event transactions occur that result in
the issuance of an individual stock trading pause by the primary
listing market and subsequent transactions that occur before the
trading pause is in effect on the Exchange.\6\ The Exchange also
adopted additional changes to Rule 128 that reduced the ability of the
Exchange to deviate from the objective standards set forth in Rule
128,\7\ and in 2013, adopted a provision designed to address the
operation of the Plan.\8\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 62886 (Sept. 10,
2010), 75 FR 56613 (Sept. 16, 2010) (SR-NYSE-2010-47).
    \7\ Id.
    \8\ See Securities Exchange Act Release No. 68804 (Feb. 1,
2013), 78 FR 8677 (Feb. 6, 2013) (SR-NYSE-2013-11); Securities
Exchange Act Release No. 67091 (May 31, 2012), 77 FR 33498 (June 6,
2012) (the ``Limit Up-Limit Down Release''); see also Exchange Rule
128(i).
---------------------------------------------------------------------------

    The Exchange believes the benefits to market participants from the
more objective clearly erroneous executions rule should continue on a
pilot basis to coincide with the operation of the Limit Up-Limit Down
Plan. The Exchange believes that continuing the pilot will protect
against any unanticipated consequences. Thus, the Exchange believes
that the protections of the Clearly Erroneous Rule should continue
while the industry gains further experience operating the Plan.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\9\ In particular, the
proposal is consistent with Section 6(b)(5) of the Act,\10\ because it
would promote just and equitable principles of trade, remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system. Although the Limit Up-Limit Down Plan is
operational, the Exchange believes that maintaining the pilot will help
to protect against unanticipated consequences. Thus, the Exchange
believes that the protections of the Clearly Erroneous Rule should
continue while the industry gains further experience operating the
Plan. The Exchange also believes that the pilot program promotes just
and equitable principles of trade in that it promotes transparency and
uniformity across markets concerning review of transactions as clearly
erroneous. Thus, the Exchange believes that the extension of the pilot
would help assure that the determination of whether a clearly erroneous
trade has occurred will be based on clear and objective criteria, and
that the resolution of the incident will occur promptly through a
transparent process. The proposed rule change would also help assure
consistent results in handling erroneous trades across the U.S.
markets, thus furthering fair and orderly markets, the protection of
investors and the public interest. Based on the foregoing, the Exchange
believes the benefits to market participants from the more objective
clearly erroneous executions rule should continue on a pilot basis to

coincide with the operation of the Limit Up-Limit Down Plan.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change
implicates any competitive issues. To the contrary, as noted above, the
Exchange believes FINRA and other national securities exchanges are
also filing similar proposals, and thus, that the proposal will help to
ensure consistency across market centers.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \11\ and Rule 19b-
4(f)(6)(iii) thereunder.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6)(iii). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the 30-day operative
delay so that the proposal may become operative immediately upon
filing. The Commission believes that waiving the 30-day operative delay
is consistent with the protection of investors and the public interest,
as it will allow the clearly erroneous pilot program to continue
uninterrupted while the industry gains further experience operating
under the Limit Up-Limit Down Plan, and avoid any investor confusion
that could result from a temporary interruption in the pilot program.
For this reason, the Commission designates the proposed rule change to
be operative upon filing.\13\
---------------------------------------------------------------------------

    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2014-17 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2014-17. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2014-17 and should be
submitted on or before April 23, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-07286 Filed 4-1-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 109 (Tuesday, June 7, 2022)]
[Notices]
[Pages 34751-34752]
[FR Doc No: 2022-12163]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2013-0106; FMCSA-2015-0017; FMCSA-2015-0320; FMCSA-
2018-0058; FMCSA-2019-0036; FMCSA-2019-0206; FMCSA-2019-0210]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of final disposition.

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

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

DATES: The exemptions were applicable on February 19, 2022. The
exemptions expire on February 19, 2024.

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

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, FMCSA-2013-0106, FMCSA-2015-0017, FMCSA-2015-0320, FMCSA-2018-
0058, FMCSA-2019-0036, FMCSA-2019-0206, or FMCSA-2019-0210 in the
keyword box, and click ``Search.'' Next, sort the results by ``Posted
(Newer-Older),'' choose the first notice listed, and click ``Browse
Comments.'' If you do not have access to the internet, you may view the
docket online by visiting Dockets Operations in Room W12-140 on the
ground floor of

the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-
0001, between 9 a.m. and 5 p.m., ET, Monday through Friday, except
Federal holidays. To be sure someone is there to help you, please call
(202) 366-9317 or<PHONE_NUMBER> before visiting Dockets Operations.

B. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption request. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov, as described in the system of records
notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

II. Background

    On February 16, 2022, FMCSA published a notice announcing its
decision to renew exemptions for eight individuals from the epilepsy
and seizure disorders prohibition in 49 CFR 391.41(b)(8) to operate a
CMV in interstate commerce and requested comments from the public (87
FR 8919). The public comment period ended on March 18, 2022, and no
comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that renewing these exemptions would achieve a level of
safety equivalent to, or greater than, the level that would be achieved
by complying with Sec.  391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in Sec.  391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce.
---------------------------------------------------------------------------

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

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Conclusion

    Based on its evaluation of the eight renewal exemption
applications, FMCSA announces its decision to exempt the following
drivers from the epilepsy and seizure disorders prohibition in Sec.
391.41(b)(8).
    As of February 19, 2022, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following eight individuals have satisfied the
renewal conditions for obtaining an exemption from the epilepsy and
seizure disorders prohibition in the FMCSRs for interstate CMV drivers
(87 FR 8919):

Daniel Bretz Jr. (PA)
Thomas DeAngelo (IL)
Robert Drake (AZ)
Pagagrong Newsome (CA)
Tyler Schaefer (ME)
Douglas Slagel (OH)
Cory Wagner (IL)
Randy Wentz (PA)

    The drivers were included in docket number FMCSA-2013-0106, FMCSA-
2015-0017, FMCSA-2015-0320, FMCSA-2018-0058, FMCSA-2019-0036, FMCSA-
2019-0206, or FMCSA-2019-0210. Their exemptions were applicable as of
February 19, 2022 and will expire on February 19, 2024.
    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) the person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315(b).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2022-12163 Filed 6-6-22; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)]
[Notices]
[Page 58562]
[FR Doc No: 2018-25269]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP19-214-001.
    Applicants: Tallgrass Interstate Gas Transmission, LLC.
    Description: Compliance filing Erata Compliance Tariff Filing RP19-
214 to be effective 11/1/2018.
    Filed Date: 11/1/18.
    Accession Number: 20181101-5178.
    Comments Due: 5 p.m. ET 11/16/18.

    Docket Numbers: RP19-283-000.
    Applicants: Gulf Crossing Pipeline Company LLC.
    Description: Sec.  4(d) Rate Filing: Remove Expired Agreements from
Tariff eff 11-13-2018 to be effective 11/13/2018.
    Filed Date: 11/13/18.
    Accession Number: 20181113-5040.
    Comments Due: 5 p.m. ET 11/26/18.

    Docket Numbers: RP19-284-000.
    Applicants: Northwest Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Supply Shortage OFO Filing to
be effective 11/27/2018.
    Filed Date: 11/13/18.
    Accession Number: 20181113-5190.
    Comments Due: 5 p.m. ET 11/26/18.

    Docket Numbers: RP19-285-000.
    Applicants: Maritimes & Northeast Pipeline, L.L.C.
    Description: Compliance filing MNUS IT Refund Report.
    Filed Date: 11/13/18.
    Accession Number: 20181113-5303.
    Comments Due: 5 p.m. ET 11/26/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 14, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-25269 Filed 11-19-18; 8:45 am]
BILLING CODE 6717-01-P


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Friday, August 19, 2016 12:18 PM
To:
<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Cc:
David Ailor<EMAIL_ADDRESS><EMAIL_ADDRESS>Raymond, Gabrielle<EMAIL_ADDRESS>Subject:
updated FAQs for Coke Ovens ICR - Qs #1-#23 - New Qs starts at #18

Please find attached updated FAQs for the Coke Oven ICR. Also posted to Coke ICR website.

Questions #1 through #23 (new FAQs start at #18)   -  August 16, 2016

_____________________________________________________________
Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D 243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

<< Coke ICR FAQs-Set#4-08-16-16.doc >>


[Federal Register: August 16, 2010 (Volume 75, Number 157)]
[Notices]
[Page 50013-50014]
[DOCID:fr16au10-121]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62667; File No. SR-NYSEAmex-2010-77]

Self-Regulatory Organizations; NYSE Amex, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending Rule 995NY

August 9, 2010.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that on August 2, 2010, NYSE Amex LLC (``NYSE Amex'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. NYSE Amex filed the proposed rule change as a ``non-
controversial'' proposal pursuant to Section 19(b)(3)(A) of the Act \4\
and Rule 19b-4(f)(6) thereunder,\5\ which renders the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
    \4\ 15 U.S.C. 78s(b)(3)(A).
    \5\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Rule 995NY-Prohibited Conduct, by
adding a provision that states that the practice of unbundling an order
is considered conduct inconsistent with just and equitable principles
of trade. The text of the proposed rule change is available on the
Exchange's Web site at http://www.nyse.com, on the Commission's Web
site at http://www.sec.gov, at the Exchange, and at the Commission's
Public Reference Room. A copy of this filing is available on the
Exchange's Web site at http://www.nyse.com, at the Exchange's principal
office and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to amend Rule 995NY by
adding subsection (d) which will expressly prohibit the splitting-up of
an order into smaller orders; a practice also know as unbundling, or
trade shredding. More specifically, the Exchange is proposing to add
language to its existing rules to prohibit NYSE Amex Options Trading
Permit Holders (``ATP Holders'') from splitting orders into multiple
smaller orders for any purpose other than best execution.
    Unbundling, or trade shredding, is the practice of breaking up an
order into multiple smaller orders for some purpose other than best
execution of the order. The practice of unbundling has in the past been
used for such purposes as improperly maximizing commissions and fees
charged to customers, distorting trade data, or circumventing rules
pertaining to maximum order size. In addition, the unbundling of a
large order into several smaller orders could be done so as to affect
the allocation of a trade among market participants pursuant to the
allocation methodology used by the Exchange.\6\ Finally, the Exchange
believes that the unbundling of orders generally serves no purpose to
the customer that entered the order and may cause unnecessary delays in
the execution of said orders.
---------------------------------------------------------------------------

    \6\ For example, pursuant to NYSE Amex Options Rule
964NY(b)(C)(iv), all orders of five contracts or less are allocated
to a Specialist Pool. If an ATP Holder was to break up a large order
into several smaller orders of five contracts or less, the
Specialist Pool could unfairly garner a greater trade allocation
than it was otherwise entitled to.
---------------------------------------------------------------------------

    Pursuant to NYSE Amex Rule 476(a)(6), ATP Holders must observe high
standards of commercial honor and just and equitable principles of
trade. NYSE Amex would consider an ATP Holder to have engaged in
conduct inconsistent with just and equitable principles of trade were
they to unbundle an order which (1) Distorts fees and/or commissions to
the detriment of a customer or the Exchange, (2) causes an unnecessary
delay in the execution of an order, or (3) circumvents an Exchange rule
or federal securities law, including those rules

pertaining to order size and trade allocation. ATP Holders engaging in
conduct inconsistent with just and equitable principles of trade are
subject to formal disciplinary action by the Exchange.
    NYSE Amex now proposes to adopt new Rule 995NY(d), which will
expressly state that the Exchange considers it to be conduct
inconsistent with just and equitable principals of trade for an ATP
Holder to split an order into multiple smaller orders for any purpose
other than seeking the best execution of the entire order.
    The Exchange believes that by adopting this proposed new rule,
which serves to codify existing Exchange procedures when dealing with
the unlawful unbundling of orders, will deter, and help to prevent this
distortive practice, and therefore promote just and equitable
principles of trade.
    The Exchange notes that other U.S. options exchanges have rules
prohibiting the unbundling of orders for a variety of reasons and
violations of these rules may be considered conduct inconsistent with
just and equitable principles of trade.\7\
---------------------------------------------------------------------------

    \7\ See International Securities Exchange Rule 723 Supplementary
Material .01, and NASDAQ OMX PHLX Rule 1015(a)(v).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Securities Exchange Act of 1934 (the ``Act''),\8\ in
general, and furthers the objectives of Section 6(b)(5) of the Act,\9\
in particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in
general, to protect investors and the public interest. The rule is
designed to deter, and help to prevent the distortive practice of
unbundling, or trade shredding, and therefore promote just and
equitable principles of trade.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \10\ and Rule 19b-4(f)(6) thereunder.\11\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \12\ and Rule 19b-
4(f)(6)(iii) thereunder.\13\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires a self-regulatory organization to provide the
Commission with written notice of its intent to file the proposed
rule change, along with a brief description and text of the proposed
rule change, at least five business days prior to the date of filing
of the proposed rule change, or such shorter time as designated by
the Commission. The Exchange has fulfilled this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAmex-2010-77 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEAmex-2010-77. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of the filing also will be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSEAmex-2010-77 and should be submitted on or before September 7,
2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-20149 Filed 8-13-10; 8:45 am]
BILLING CODE 8010-01-P