[Federal Register Volume 84, Number 28 (Monday, February 11, 2019)]
[Notices]
[Pages 3190-3191]
[FR Doc No: 2019-01826]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4731]

Enhancing the Incorporation of Patient Perspectives on Clinical
Trials; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Enhancing the
Incorporation of Patient Perspectives on Clinical Trials'' and an
opportunity for public comment. The workshop will be convened by the
Clinical Trials Transformation Initiative (CTTI). The topic to be
discussed is stakeholders' (including patients, caregivers, industry,
academic researchers, and expert practitioners) perspectives on
challenges and barriers to patients participating in clinical trials
and best practices and key considerations for enhancing the
incorporation of patient perspectives on clinical trial access, design,
conduct, and post-trial followup. The workshop will result in a
publicly available report from CTTI on proceedings and recommendations
from discussions at the workshop. This workshop is intended to meet an
FDA commitment included in the sixth authorization of the Prescription
Drug User Fee Amendments of 2017 (PDUFA VI).

DATES: The public workshop will be held on March 18, 2019, from 9 a.m.
to 5 p.m. Submit either electronic or written comments on this public
workshop by May 20, 2019. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: The public workshop will be held at the Tommy Douglas
Conference Center, 10000 New Hampshire Ave., Silver Spring, MD 20903.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before May 20, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of May 20, 2019. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-4731 for ``Patient Engagement on Clinical Trials; Public
Workshop; Request for Comments.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug

Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 301-
796-5003, Fax:<PHONE_NUMBER><EMAIL_ADDRESS>or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This public workshop is intended to meet one of the performance
goals included in PDUFA VI. This PDUFA reauthorization is part of the
FDA Reauthorization Act of 2017 signed by the President on August 18,
2017. The complete set of performance goals and procedures documented
in the PDUFA Reauthorization Performance Goals And Procedures Fiscal
Years 2018 Through 2022 (Goals Letter) is available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf. These goals were developed in consultation with patient
and consumer advocates, health care professionals, and other public
stakeholders, as part of negotiations with regulated industry. Section
I.J.1 of the Goals Letter, ``Enhancing the Incorporation of the
Patient's Voice in Drug Development and Decision-Making,'' outlines the
requirement for FDA to conduct a public workshop.

II. Topics for Discussion at the Public Workshop

    This workshop will provide FDA the opportunity to better understand
patients' perspectives on current barriers to participating in clinical
trials and will discuss best practices and key considerations for
enhancing the incorporation of patient perspectives into clinical trial
development. At the workshop, patients (including patients with
experience in participating in clinical trials and patients who have
not participated in clinical trials but who are interested in doing
so), caregivers, and other patient representatives will provide
perspectives on several key topics related to clinical trials. These
topics will include challenges and barriers patients face with access
to trials, trial design, trial conduct, and trial followup. The meeting
will also gather input from patients, caregivers, industry experts,
academic researchers, and other external stakeholders on approaches and
best practices to address these challenges and barriers. For more
information on meeting topics and discussion questions, visit http://events.r20.constantcontact.com/register/event?llr=w8jl4kkab&oeidk=a07efuk61xm39d90653. FDA will also post the
agenda and other workshop materials to this site approximately 5
business days before the workshop.
    The format of the meeting will consist of a series of
presentations, panel discussions, and audience Q&A. In addition to
input generated through this public workshop, FDA is interested in
receiving input through written comments, which can be submitted to the
public docket (see ADDRESSES).

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the
following website https://events.r20.constantcontact.com/register/eventReg?oeidk=a07efuk61xm39d90653&oseq=&c=&ch. Please register by
March 11, 2019. Persons without access to the internet can call 919-
668-5938 to register. If you are unable to attend the workshop in
person, you can register to view a live webcast of the workshop. You
will be asked to indicate in your registration if you plan to attend in
person or via the webcast. Please provide complete contact information
for each attendee, including name, title, affiliation, address, email,
and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by March 11, 2019, 11:59 p.m. Eastern Time.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation once they have been
accepted. If time and space permit, onsite registration on the day of
the public workshop will be provided beginning at 8 a.m. We will let
registrants know if registration closes before the day of the public
workshop.
    If you need special accommodations due to a disability, please
contact Graham Thompson (see FOR FURTHER INFORMATION CONTACT) no later
than March 11, 2019, 11:59 p.m. Eastern Time.
    Streaming Webcast of the Public Workshop: This public workshop will
also be webcast. Please register for the webcast by visiting https://events.r20.constantcontact.com/register/eventReg?oeidk=a07efuk61xm39d90653&oseq=&c=&ch=.
    FDA has verified the website addresses in this document, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It also may be viewed at the Dockets Management
Staff (see ADDRESSES).

    Dated: January 24, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-01826 Filed 2-8-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 25 (Tuesday, February 9, 2021)]
[Notices]
[Pages 8786-8791]
[FR Doc No: 2021-02660]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2020-0077; FRL-10018-37]

Certain New Chemicals; Receipt and Status Information for
November 2020

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 11/01/
2020 to 11/30/2020.

DATES: Comments identified by the specific case number provided in this
document must be received on or before March 11, 2021.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0077, and the specific case number for the
chemical substance related to your comment, by one of the following
methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental

Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    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:
(202) 564-8593; 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

A. What action is the Agency taking?

    This document provides the receipt and status reports for the
period from 11/01/2020 to 11/30/2020. 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 11/01/2020 to 11/30/2020
----------------------------------------------------------------------------------------------------------------
      Case No.         Version     Received date    Manufacturer             Use             Chemical substance
----------------------------------------------------------------------------------------------------------------
J-20-0005..........            2      10/16/2020  CBI.............  (G) Ethanol            (G) Saccharomyces
                                                                     production.            cerevisiae modified.
J-20-0013..........            3      10/27/2020  Greenlight        (G) Production of      (G) Modified strains
                                                   Biociences, Inc.  enzymes for use in     of Escherichia coli.
                                                                     internal
                                                                     manufacturing.
J-20-0014..........            3      10/27/2020  Greenlight        (G) Production of      (G) Modified strains
                                                   Biociences, Inc.  enzymes for use in     of Escherichia coli.
                                                                     internal
                                                                     manufacturing.
J-20-0015..........            3      10/27/2020  Greenlight        (G) Production of      (G) Modified strains
                                                   Biociences, Inc.  enzymes for use in     of Escherichia coli.
                                                                     internal
                                                                     manufacturing.
J-20-0016..........            3      10/27/2020  Greenlight        (G) Production of      (G) Modified strains
                                                   Biociences, Inc.  enzymes for use in     of Escherichia coli.
                                                                     internal
                                                                     manufacturing.
J-20-0017..........            3      10/27/2020  Greenlight        (G) Production of      (G) Modified strains
                                                   Biociences, Inc.  enzymes for use in     of Escherichia coli.
                                                                     internal
                                                                     manufacturing.
J-20-0018..........            3      10/27/2020  Greenlight        (G) Production of      (G) Modified strains
                                                   Biociences, Inc.  enzymes for use in     of Escherichia coli.
                                                                     internal
                                                                     manufacturing.
J-20-0025..........            3      11/03/2020  CBI.............  (G) Ethanol            (G) Biofuel producing
                                                                     production.            Saccharomyces
                                                                                cerevisiae modified,
                                                                                genetically stable.
P-18-0057A.........           12      11/12/2020  CBI.............  (S) a drier            (G) Vanadium
                                                                     accelerator that is    Carboxylate.
                                                                     used for superior
                                                                     drying performance
                                                                     in solvent-borne and
                                                                     waterborne air-dried
                                                                     paints, inks and
                                                                     coatings.
P-18-0057A.........           13      11/18/2020  CBI.............  (S) a drier            (G) Vanadium
                                                                     accelerator that is    Carboxylate.
                                                                     used for superior
                                                                     drying performance
                                                                     in solvent-borne and
                                                                     waterborne air-dried
                                                                     paints, inks and
                                                                     coatings.
P-18-0057A.........           14      11/23/2020  CBI.............  (S) a drier            (G) Vanadium
                                                                     accelerator that is    Carboxylate.
                                                                     used for superior
                                                                     drying performance
                                                                     in solvent-borne and
                                                                     waterborne air-dried
                                                                     paints, inks and
                                                                     coatings.
P-18-0084A.........            9      11/23/2020  ShayoNano USA,    (S) Additive for       (S) silicon zinc
                                                   Inc.              water-based paints     oxide.
                                                                     and coatings.
P-18-0256A.........            7      11/11/2020  CBI.............  (G) Chemical           (S) Undecanol,
                                                                     Intermediate.          branched.
P-18-0293A.........            6      11/17/2020  CBI.............  (S) Monomer for use    (S) Propanedioic
                                                                     in emulsion            acid, 2-methylene-,
                                                                     polymers, formulated   1,3-dihexyl ester.
                                                                     industrial coatings,
                                                                     industrial adhesives.
P-18-0293A.........            7      11/20/2020  CBI.............  (S) Monomer for use    (S) Propanedioic
                                                                     in emulsion            acid, 2-methylene-,
                                                                     polymers, formulated   1,3-dihexyl ester.
                                                                     industrial coatings,
                                                                     industrial adhesives.
P-18-0294A.........            6      11/17/2020  CBI.............  (S) Monomer for use    (S) Propanedioic
                                                                     in emulsion            acid, 2-methylene-,
                                                                     polymers, formulated   1,3-dicyclohexyl
                                                                     industrial coatings,   ester.
                                                                     industrial adhesives.
P-18-0294A.........            7      11/20/2020  CBI.............  (S) Monomer for use    (S) Propanedioic
                                                                     in emulsion            acid, 2-methylene-,
                                                                     polymers, formulated   1,3-dicyclohexyl
                                                                     industrial coatings,   ester.
                                                                     industrial adhesive.
P-18-0345A.........            3      11/24/2020  Chitec            (S) R-gen 990 is a     (S) 1-Butanone, 2-
                                                   Technology Co.,   liquid aminoketone-    (dimethylamino)-1-[4-
                                                   Ltd.              based photoinitator    (2-ethyl-2-methyl-3-
                                                                     (PI) intended for      oxazolidinyl)phenyl]-
                                                                     use as an              2-(phenylmethyl)-.
                                                                     ultraviolet (UV)
                                                                     curing agent in
                                                                     highly pigmented
                                                                     inks, photoresists,
                                                                     and masks.

P-19-0082A.........            5      11/12/2020  Bedoukian         (S) Fragrance uses     (S) Heptanal, 6-
                                                   Research Inc.     per FFDCA: Fine        hydroxy-2,6-dimethyl-
                                                                     fragrance, creams,     .
                                                                     lotions, etc., TSCA:
                                                                     Scented papers,
                                                                     candles, detergents,
                                                                     cleaners, etc.
P-20-0010A.........           11      11/04/2020  CBI.............  (G) Polymerization     (G) Carboxylic acid,
                                                                     auxiliary.             reaction products
                                                                                with metal
                                                                                hydroxide, inorganic
                                                                                dioxide and metal.
P-20-0031A.........            5      11/02/2020  CBI.............  (G) Intermediate.....  (G) Perfluorinated
                                                                                substituted 1,3-
                                                                                oxathiolane dioxide.
P-20-0070A.........            2      11/07/2020  Clariant          (S) Solvent for use    (S) Nonanamide, N,N-
                                                   Corporation.      in formulated          dimethyl-.
                                                                     pesticide products.
P-20-0076A.........            4      11/04/2020  Cytec Industries  (G) Mining chemical..  (S) Glycine, reaction
                                                   Inc.                                     products with sodium
                                                                                O-iso-Pr
                                                                                carbonodithioate,
                                                                                sodium salts.
P-20-0077A.........            6      11/23/2020  CBI.............  (S) UV Curing Agent    (G) 1-(dialkyl-
                                                                     for use in Inks and    diphenylene alkane)-
                                                                     Coatings.              2-alkyl-2-
                                                                                hydrooxazine-1-
                                                                                alkylketone.
P-20-0078A.........            2      11/11/2020  Ascend            (G) Stabilizer for     (G) Dicarboxylic
                                                   Performance       industrial             acid, compd. with
                                                   Materials.        applications.          aminoalkyl-
                                                                                alkyldiamine
                                                                                alkyldioate
                                                                                alkyldioate
                                                                                (1:2:1:1).
P-20-0079A.........            2      11/11/2020  Ascend            (G) Stabilizer for     (G) Dicarboxylic
                                                   Performance       industrial             acid, compd. with
                                                   Materials.        applications.          aminoalkyl-
                                                                                alkyldiamine (3:2).
P-20-0080A.........            5      11/11/2020  Ascend            (G) Stabilizer for     (G) Alkyldiamine,
                                                   Performance       industrial             aminoalkyl-,
                                                   Materials.        applications.          hydrochloride (1:3).
P-20-0081A.........            5      11/11/2020  Ascend            (G) A stabilizer for   (G) Carboxylic acid,
                                                   Performance       industrial             compd. with
                                                   Materials.        applications.          aminoalkyl-
                                                                                alkyldiamine (3:1).
P-20-0082A.........            5      11/11/2020  Ascend            (G) Stabilizer for     (G) Alkyldiamine,
                                                   Performance       industrial             aminoalkyl-,
                                                   Materials.        applications.          carboxylate (1:3).
P-20-0094A.........            3      11/12/2020  CBI.............  (S) Formulation        (G) Alkanedioic acid,
                                                                     component in UV/EB     polymer with tri-
                                                                     coatings, inks and     alkyl-
                                                                     3D printing/           isocyanatocarbomonoc
                                                                     stereolithography/     ycle,
                                                                     additive and           dialkylglycols,
                                                                     adhesive               ester with 2,3-
                                                                     manufacturing.         dihydroxypropyl
                                                                                alkyl ester, 2-
                                                                                hydroxyethyl
                                                                                methacrylate-
                                                                                blocked.
P-20-0105A.........            3      11/25/2020  Sound             (S) Maltol lactone is  (S) 4H-Pyran-4-one, 3-
                                                   Agriculture       a compound that        [(2,5-dihydro-4-
                                                   Company.          promotes microbial     methyl-5-oxo-2-
                                                                     activity in the        furanyl)oxy]-2-
                                                                     soil, resulting in     methyl-.
                                                                     increased
                                                                     availability of
                                                                     phosphorus for
                                                                     crops. This
                                                                     substance will be
                                                                     used on commercial
                                                                     farming operations.
P-20-0127A.........            4      11/12/2020  Kuraray America,  (S) Industrial         (S) 2H-Pyran,
                                                   Inc.              Solvent.               tetrahydro-4-methyl-
                                                                                .
P-20-0138A.........            4      11/20/2020  Gurit (USA) Inc.  (S) The substance is   (G) Alkane diglycidy
                                                                     part of a mixture      ether, polymer with
                                                                     with other amines to   alkyl-cycloalkane
                                                                     act as a curative      diamines.
                                                                     for a 2-part epoxy
                                                                     adhesive
                                                                     formulation. The new
                                                                     substance will be
                                                                     used within an
                                                                     adhesive formulation
                                                                     for use within an
                                                                     industrial setting
                                                                     primarily but not
                                                                     limited to
                                                                     industries such as
                                                                     marine, automotive
                                                                     and wind energy.
P-20-0146A.........            2      11/06/2020  CBI.............  (G) Insulating         (G) Alkanoic acid,
                                                                     material for           alkyl,
                                                                     electrical parts.      carbopolycyclic
                                                                                alkyl ester.
P-20-0148..........            2      11/12/2020  Solugen Inc.....  (G) Additive for       (G) Hydroxyalkanoic
                                                                     consumer,              acid, salt,
                                                                     industrial, and        oxidized.
                                                                     commercial uses.
P-20-0149..........            2      11/12/2020  Solugen Inc.....  (G) Additive for       (G) Hydroxyalkanoic
                                                                     consumer,              acid, salt,
                                                                     industrial, and        oxidized.
                                                                     commercial uses.
P-20-0150..........            2      11/12/2020  Solugen, Inc....  (G) Additive for       (G) Hydroxyalkanoic
                                                                     consumer,              acid, salt,
                                                                     industrial, and        oxidized.
                                                                     commercial uses.
P-20-0151..........            2      11/12/2020  Solugen, Inc....  (G) Additive for       (G) Hydroxyalkanoic
                                                                     consumer,              acid, salt,
                                                                     industrial, and        oxidized.
                                                                     commercial uses.
P-20-0153A.........            4      11/04/2020  CBI.............  (G) lubricant          (G) Polyamines,
                                                                     additive--dispersant.  reaction products
                                                                                with succinic
                                                                                anhydride
                                                                                polyalkenyl derivs.,
                                                                                borates.
P-20-0154A.........            4      11/04/2020  CBI.............  (G) lubricant          (G) Polyamines,
                                                                     additive--dispersant.  reaction products
                                                                                with succinic
                                                                                anhydride
                                                                                polyalkenyl derivs.,
                                                                                borates.
P-20-0161A.........            2      11/04/2020  Sirrus, Inc.....  (S) Film former or     (S) Propanedioic
                                                                     crosslinker additive   acid, 2-methylene-,
                                                                     used in coatings,      1,3-diethyl ester,
                                                                     waterborne             polymer with 1,4-
                                                                     emulsions, adhesives.  butanediol.

P-20-0169..........            3      11/23/2020  CBI.............  (G) Battery Plastics   (S) multiwalled
                                                                     and coatings           carbon nanotube.
                                                                     applications,
                                                                     Conductive agent for
                                                                     conductive plastic
                                                                     and paint.
P-20-0183A.........            2      11/16/2020  CBI.............  (G) Intermediate.....  (G) Aryl ether
                                                                                epoxide,
                                                                                homopolymer, ether
                                                                                with alkanolamine.
P-21-0003..........            3      11/04/2020  CBI.............  (G) Polymeric film     (G) 4, 4 methylenebis
                                                                     former for coatings.   (2, 6 dimethyl
                                                                                phenol) polymer with
                                                                                2- (chloromethyl)
                                                                                oxirane, 1,4-benzene
                                                                                diol, 2-methyl-2-
                                                                                propenoic acid,
                                                                                mixed alkyl
                                                                                substituted 2-methyl
                                                                                2-propenoate, and
                                                                                ethyl 2-propenoate,
                                                                                reaction products
                                                                                with 2-
                                                                                (dimthylamino)
                                                                                ethanol.
P-21-0004..........            3      11/11/2020  CBI.............  (G) Surfactant.......  (G) Poly alkyl glycol
                                                                                alkyl ether.
P-21-0011..........            2      11/04/2020  CBI.............  (S) Crosslinking       (G) Hexane, 1,6-
                                                                     agent for inks and     diisocyanato-,
                                                                     coatings.              homopolymer, alkyl
                                                                                epoxy ether- and
                                                                                polyethylene glycol
                                                                                mono-Me ether-
                                                                                blocked, reaction
                                                                                products with
                                                                                propylenimine.
P-21-0012..........            1      10/28/2020  CBI.............  (G) The notified       (G)
                                                                     substance will be      Multialkylbicycloalk
                                                                     used as a fragrance    enyl substituted
                                                                     ingredient.            propanenitrile.
P-21-0013..........            2      11/24/2020  Takasago........  (S) Fragrance in fine  (G) methyl
                                                                     fragrance,             phenylethyl
                                                                     deodorants and         cyclopropanemethanol
                                                                     cosmetics, household   .
                                                                     products such as
                                                                     laundry detergents
                                                                     and air fresheners,
                                                                     Shampoos and Body
                                                                     Washes.
P-21-0014..........            2      11/06/2020  CBI.............  (G) oil and gas        (G) Aliphatic
                                                                     extraction.            alcohol, bis-tetra-
                                                                                alkyl ammonium,
                                                                                chloride salts.
P-21-0015..........            1      10/30/2020  Designer          (S) As a raw material  (S) Amines, C36-
                                                   Molecules, Inc.   in a Temporary         alkylenedi-,
                                                                     Bonding Adhesive       polymers with 5,5'-
                                                                     formulation.           [(1-
                                                                                methylethylidene)bis
                                                                                (4,1-
                                                                                phenyleneoxy)]bis[1,
                                                                                3-
                                                                                isobenzofurandione]
                                                                                and 4,4'-[2,2,2-
                                                                                trifluoro-1-
                                                                                (trifluoromethyl)eth
                                                                                ylidene]bis[2-
                                                                                aminophenol].
P-21-0016..........            1      11/02/2020  CBI.............  (G) Paint additive,    (G) Alkanoic acid,
                                                                     Additive in coating    dialkyl ester.
                                                                     formulations,
                                                                     Component in
                                                                     cleaning agents.
P-21-0017..........            1      11/12/2020  Sumitomo          (S) Substance used to  (G) [(Substituted-
                                                   Chemical          improve physical       carbomonocyclic)
                                                   Advanced          properties in rubber   amino] oxoalkenoic
                                                   Technologies      products.              acid, inorganic
                                                   LLC.                                     salt.
P-21-0018..........            1      11/12/2020  Shin-Etsu         (G) Contained use for  (G) Sulfonium,
                                                   Microsi.          microlithography for   triphenyl-,
                                                                     electronic device      heterocyclic
                                                                     manufacturing.         compound-carboxylate
                                                                                (1:1).
P-21-0019..........            2      11/17/2020  CBI.............  (G) The notified       (G) Ethyl 4-alkyl-2-
                                                                     substance will be      oxocycloalkanecarbox
                                                                     used as a fragrance    ylate.
                                                                     ingredient.
P-21-0022..........            1      11/20/2020  CBI.............  (S) Flexographic       (G) Rosin acid
                                                                     water-based Ink &      esters.
                                                                     coating vehicle.
P-21-0023..........            1      11/23/2020  CBI.............  (G) Photolithography.  (G) Sulfonium,
                                                                                carbocyclic-, salt
                                                                                with 1-(alkyl) 2-[4-
                                                                                [polyhydro-2-
                                                                                carbomonocyclic-5-
                                                                                (polyfluoro-2-
                                                                                sulfoalkyl)-4,7-
                                                                                methano-1,3-
                                                                                benzodioxol-2-
                                                                                yl]carbomonocyclic
                                                                                oxy]acetate (1:1).
P-21-0027..........            1      11/23/2020  CBI.............  (G) An ingredient      (G) Heteropolycyclic,
                                                                     used in the            trihaloalkyl
                                                                     manufacture of         carbomonocycle-,
                                                                     photoresist.           hydroxy
                                                                                carbomonocyclic
                                                                                salt.
SN-17-0006A........            5      10/29/2020  CBI.............  (G) Physical           (G) Potassium
                                                                     characteristics        Titanate.
                                                                     modifier for
                                                                     industrial use in
                                                                     certain solid
                                                                     composite articles.
----------------------------------------------------------------------------------------------------------------
* 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 11/01/2020 to 11/30/2020
----------------------------------------------------------------------------------------------------------------
                                            Commencement      If amendment, type of
        Case No.           Received date        date                amendment             Chemical substance
----------------------------------------------------------------------------------------------------------------
P-09-0492...............      10/30/2020        10/29/2020  N.......................  (G) Isocyanate polymer,
                                                                                amine blocked.
P-17-0387...............      11/03/2020        10/22/2020  N.......................  (G) Dicarboxylic acids,
                                                                                polymers with alkanoic
                                                                                acid, alkanediol,
                                                                                substituted-alkylalkanoic
                                                                                acid, substituted alkyl
                                                                                carbomonocyle,
                                                                                alkanedioic acid and
                                                                                alkanediol, alkanolamine
                                                                                blocked, compds. with
                                                                                alkanolamine.
P-18-0355...............      11/19/2020        11/10/2020  N.......................  (G) Alkanediol,
                                                                                substituted alkyl,
                                                                                polymer with
                                                                                carbomonocyle,
                                                                                alkanedioate substituted
                                                                                carbomonocycle, ester
                                                                                with substituted
                                                                                alkanoate.
P-19-0038...............      11/23/2020        11/20/2020  N.......................  (S) Fatty acids, coco, iso-
                                                                                bu esters.
P-20-0098...............      11/20/2020        11/13/2020  N.......................  (G) Calcium
                                                                                cycloaklylcarboxylate.
P-20-0160...............      11/23/2020        11/18/2020  N.......................  (S) Amines,c36-alkylenedi-
                                                                                , polymers with
                                                                                bicyclo[2.2.1]heptanedime
                                                                                thanamine, [5,5'-
                                                                                biisobenzofuran]-
                                                                                1,1',3,3'-tetrone and
                                                                                3a,4,4a,7a,8,8a-hexahydro-
                                                                                4,8-ethano1h,3h-benzo[1,2-
                                                                                c:4,5-c']difuran-1,3,5,7-
                                                                                tetrone, maleated.
----------------------------------------------------------------------------------------------------------------
* 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 11/01/2020 to 11/30/2020
----------------------------------------------------------------------------------------------------------------
            Case No.              Received date    Type of test information            Chemical substance
----------------------------------------------------------------------------------------------------------------
P-20-0066......................      11/24/2020  Daphnia Magna Reproduction    (G) 2-propenoic acid, 2-
                                                  Study (OECD Test Guideline    hydroxyethyl ester, reaction
                                                  211).                         products with dialkyl hydrogen
                                                                                heterosubstituted phosphate and
                                                                                dimethyl phosphonate.
----------------------------------------------------------------------------------------------------------------

    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: January 5, 2021.
Pamela Myrick,
Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2021-02660 Filed 2-8-21; 8:45 am]
BILLING CODE 6560-50-P