[Federal Register Volume 81, Number 133 (Tuesday, July 12, 2016)]
[Notices]
[Pages 45148-45153]
[FR Doc No: 2016-16448]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0024; FRL-9948-32]

Certain New Chemicals; Receipt and Status Information for May
2016

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA)
to publish in the Federal Register a notice of receipt of a
premanufacture notice (PMN); an application for a test marketing
exemption (TME), both pending and/or expired; and a periodic status
report on any new chemicals under EPA review and the receipt of notices
of commencement (NOC) to manufacture those chemicals. This document
covers the period from May 2, 2016 to May 31, 2016.

DATES: Comments identified by the specific case number provided in this
document, must be received on or before August 11, 2016.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2016-0024, and the specific PMN number or TME
number for the chemical related to your comment, by one of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim
Rahai, IMD (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. General Information

A. Does this action apply to me?

    This action is directed to the public in general. As such, the
Agency has not attempted to describe the specific entities that this
action may apply to. Although others may be affected, this action
applies directly to the submitters of the actions addressed in this
document.

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

    1. Submitting 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. What action is the agency taking?

    This document provides receipt and status reports, which cover the
period from May 2, 2016 to May 31, 2016, and consists of the PMNs and
TMEs both pending and/or expired, and the NOCs to manufacture a new
chemical that the Agency has received under TSCA section 5 during this
time period.

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

    Under TSCA, 15 U.S.C. 2601 et seq., EPA classifies a chemical
substance as either an ``existing'' chemical or a ``new'' chemical. Any
chemical substance that is not on EPA's TSCA Inventory is classified as
a ``new chemical,'' while those that are on the TSCA Inventory are
classified as an ``existing chemical.'' For more information about the
TSCA Inventory go to: http://www.epa.gov/opptintr/newchems/pubs/inventory.htm.
    Anyone who plans to manufacture or import a new chemical substance
for a non-exempt commercial purpose is required by TSCA section 5 to
provide EPA with a PMN, before initiating the activity. Section 5(h)(1)
of TSCA authorizes EPA to allow persons, upon application, to
manufacture (includes import) or process a new chemical substance, or a
chemical substance subject to a significant new use rule (SNUR) issued
under TSCA section 5(a), for ``test marketing'' purposes, which 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(d)(2) and 5(d)(3), EPA is required to publish
in the Federal Register a notice of receipt of a PMN or an application
for a TME and to publish in the Federal Register periodic reports on
the status of new chemicals under review and the receipt of NOCs to
manufacture those chemicals.

IV. Receipt and Status Reports

    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 the information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI.
    For the 66 PMNs received by EPA during this period, Table 1
provides the following information (to the extent that such information
is not claimed as CBI): The EPA case number assigned to the PMN; the
date the PMN was received by EPA; the projected end date for EPA's
review of the PMN; the submitting manufacturer/importer; the potential
uses identified by the manufacturer/importer in the PMN; and the
chemical identity.

                                                 Table 1--PMNs Received From May 2, 2016 to May 31, 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Projected end
               Case No.                 Date received   date for EPA    Manufacturer/ Importer            Use(s)                 Chemical identity
                                                           review
--------------------------------------------------------------------------------------------------------------------------------------------------------
P-16-0387............................       5/31/2016       8/29/2016  CBI.....................  (G) Additives for         (G) Aliphatic polycarboxylic
                                                                                polymers.                 acid, polymer with alicyclic
                                                                                polyhydric alcohol and
                                                                                polyoxyalkylene.
P-16-0393............................       5/31/2016       8/29/2016  CBI.....................  (S) Plasticizer for use   (G) Di-substituted
                                                                                with polymers.            benzenedicarboxylic acid
                                                                                ester.
P-16-0102............................       5/13/2016       8/11/2016  CBI.....................  (G) Ink component.......  (G) Polyester acrylate.
P-16-0102............................       5/13/2016       8/11/2016  CBI.....................  (G) Coating component...  (G) Polyester acrylate.
P-16-0102............................       5/13/2016       8/11/2016  CBI.....................  (G) Adhesive component..  (G) Polyester acrylate.
P-16-0205............................       5/17/2016       8/15/2016  CBI.....................  (S) General industrial    (G) Amide.
                                                                                oil.
P-16-0205............................       5/17/2016       8/15/2016  CBI.....................  (S) Hydraulic oil.......  (G) Amide.
P-16-0205............................       5/17/2016       8/15/2016  CBI.....................  (G) Lubricant oil.......  (G) Amide.
P-16-0271............................       5/20/2016       8/18/2016  CBI.....................  (S) Flexible pvc          (S) 1,2,4-
                                                                                plasticizer for wire      benzenetricarboxylic acid,
                                                                                insulation.               1,2,4-trinonyl ester.
P-16-0282............................       5/10/2016        8/8/2016  CBI.....................  (S) Paint dryier........  (G) Manganese complexes.
P-16-0323............................       5/17/2016       8/15/2016  Allnex USA, Inc.........  (G) Coating resin.......  (G) Formaldehyde, reaction
                                                                                products with substituted
                                                                                carbomonocycle-substituted
                                                                                heteromonocycle-alkylene
                                                                                glycol bis
                                                                                [[[substituted(oxoneoalky)ox
                                                                                y]alkyl]amino]alky] ether
                                                                                polymer and alkyl
                                                                                substituted alkanediamine,
                                                                                acetate (salts).
P-16-0348............................        5/7/2016        8/5/2016  CBI.....................  (G) Industrial lubricant  (G) Polypentaerythritol,
                                                                                mixed esters with linear and
                                                                                branched monoacids.
P-16-0349............................       5/11/2016        8/9/2016  CBI.....................  (G) Fuel additive.......  (G) Quaternary ammonium salt
                                                                                of polyisobutene succinic
                                                                                acid.
P-16-0350............................        5/2/2016       7/31/2016  CBI.....................  (G) Polymer reactant....  (G) Polyaralkyl aryl ester of
                                                                                methacrylic acid.
P-16-0351............................        5/2/2016       7/31/2016  Solazyme, Inc...........  (G) Renewable oil source  (G) Glycerides, c14-18 and
                                                                                for fuels.                c16-c18 unsaturated, from
                                                                                fermentation.
P-16-0351............................        5/2/2016       7/31/2016  Solazyme, Inc...........  (G) Feedstock for         (G) Glycerides, c14-18 and
                                                                                oleochemical industry.    c16-c18 unsaturated, from
                                                                                fermentation.
P-16-0353............................        5/4/2016        8/2/2016  Gantrade Corp...........  (S) Chain extender and    (S) Benzenamine, 4-[(4-amino-
                                                                                curative for use in       3-chlorophenyl)methyl]-2-
                                                                                polymer manufacturing.    ethyl-.
P-16-0354............................        5/5/2016        8/3/2016  CBI.....................  (G) Intermediate........  (G) Esteramine.
P-16-0355............................        5/5/2016        8/3/2016  CBI.....................  (G) Intermediate........  (G) Esteramine.
P-16-0356............................        5/5/2016        8/3/2016  CBI.....................  (G) Wellbore additive...  (G) Quaternary ammonium
                                                                                salts.
P-16-0357............................        5/5/2016        8/3/2016  CBI.....................  (G) Wellbore additive...  (G) Quaternary ammonium
                                                                                salts.
P-16-0358............................        5/5/2016        8/3/2016  CBI.....................  (S) Intermediate for      (G) Alkylphenol.
                                                                                further polymer
                                                                                reaction.
P-16-0359............................        5/5/2016        8/3/2016  Dic International, USA,   (G) Pigment additive for  (G) Carbopolycycle-
                                                                        LLC.                      industrial coatings.      bis(diazonium), dihalo-,
                                                                                chloride (1:2), reaction
                                                                                products with metal
                                                                                hydroxide, 4-
                                                                                [(dioxoalkyl)amino]substitut
                                                                                ed benzene, 2-
                                                                                [(dioxoalkyl)amino]substitut
                                                                                ed benzene, 5-
                                                                                [(dioxoalkyl)amino]-2-
                                                                                hydroxy-substituted benzene
                                                                                and oxo-n-phenylalkanamide.

P-16-0359............................        5/5/2016        8/3/2016  Dic International USA,    (G) Pigment additives     (G) Carbopolycycle-
                                                                        LLC.                      for industrial coatings.  bis(diazonium), dihalo-,
                                                                                chloride (1:2), reaction
                                                                                products with metal
                                                                                hydroxide, 4-
                                                                                [(dioxoalkyl)amino]substitut
                                                                                ed benzene, 2-
                                                                                [(dioxoalkyl)amino]substitut
                                                                                ed benzene, 5-
                                                                                [(dioxoalkyl)amino]-2-
                                                                                hydroxy-substituted benzene
                                                                                and oxo-n-phenylalkanamide.
P-16-0360............................        5/6/2016        8/4/2016  Oleon Americas, Inc.....  (G) Fuel additive.......  (S) Poly (oxy-1,2-
                                                                                ethanediyl), alpha- (1-
                                                                                oxodocosyl)- omega- [(1-
                                                                                oxodocosyl)oxy]-.
P-16-0361............................       5/12/2016       8/10/2016  American Process, Inc...  (G) Plastic               (S) Pulp, cellulose, reaction
                                                                                reinforcement.            products with lignin
                                                                                [nanocrystals].
P-16-0361............................       5/12/2016       8/10/2016  American Process, Inc...  (G) Binders.............  (S) Pulp, cellulose, reaction
                                                                                products with lignin
                                                                                [nanocrystals].
P-16-0361............................       5/12/2016       8/10/2016  American Process, Inc...  (G) Viscosifying agent..  (S) Pulp, cellulose, reaction
                                                                                products with lignin
                                                                                [nanocrystals].
P-16-0362............................       5/12/2016       8/10/2016  American Process, Inc...  (G) Binders.............  (S) Pulp, cellulose, reaction
                                                                                products with lignin
                                                                                [nanofibrils].
P-16-0362............................       5/12/2016       8/10/2016  American Process, Inc...  (G) Plastic               (S) Pulp, cellulose, reaction
                                                                                reinforcement.            products with lignin
                                                                                [nanofibrils].
P-16-0362............................       5/12/2016       8/10/2016  American Process, Inc...  (G) Viscosifying agent..  (S) Pulp, cellulose, reaction
                                                                                products with lignin
                                                                                [nanofibrils].
P-16-0363............................       5/10/2016        8/8/2016  CBI.....................  (G) Open, non-dispersive  (G) Blocked polyester
                                                                                polyurethane, neutralized.
P-16-0364............................       5/10/2016        8/8/2016  CBI.....................  (G) Intermediate used     (G) Nitrile-butadiene-
                                                                                completely on site.       acrylate terpolymers.
P-16-0365............................       5/16/2016       8/14/2016  Allnex USA, Inc.........  (S) Ultra violet curable  (G) Alkyl carbonate, polymer
                                                                                coating resin.            with, substituted alkanes
                                                                                and substituted
                                                                                heteromonocycle, substituted
                                                                                alkyl acrylate-blocked.
P-16-0366............................       5/11/2016        8/9/2016  CBI.....................  (G) Open, non-dispersive  (G) Blocked polyisocyanate.
P-16-0367............................       5/20/2016       8/18/2016  Allnex USA, Inc.........  (S) Ultra violet curable  (G) Substituted
                                                                                coating resin.            heteromonocylce, polymer
                                                                                with substituted alkane and
                                                                                ethoxylated
                                                                                alkane[acirc][iquest][atilde
                                                                                ][iquest][acirc][iquest][ati
                                                                                lde][iquest][acirc][cent][at
                                                                                ilde][iquest][acirc][iquest]
                                                                                [atilde][iquest][acirc][ique
                                                                                st][atilde][iquest][acirc][i
                                                                                quest][atilde][iquest][acirc
                                                                                ][iquest][atilde][iquest][ac
                                                                                irc][iquest], substituted
                                                                                heteromonocycle substituted
                                                                                [acirc][iquest][atilde][ique
                                                                                st][acirc][iquest][atilde][i
                                                                                quest][acirc][cent][atilde][
                                                                                iquest][acirc][iquest][atild
                                                                                e][iquest][acirc][iquest][at
                                                                                ilde][iquest][acirc][iquest]
                                                                                [atilde][iquest][acirc][ique
                                                                                st][acirc][iquest][atilde][i
                                                                                quest][acirc][iquest]alkyl
                                                                                ester-
                                                                                [acirc][iquest][atilde][ique
                                                                                st][acirc][iquest][atilde][i
                                                                                quest][acirc][cent][atilde][
                                                                                iquest][acirc][iquest][atild
                                                                                e][iquest][acirc][iquest][at
                                                                                ilde][iquest][acirc][iquest]
                                                                                [atilde][iquest][acirc][ique
                                                                                st][acirc][iquest]blocked.
P-16-0368............................       5/13/2016       8/11/2016  CBI.....................  (S) Adhesive coating for  (G) Aromatic dicarboxylic
                                                                                carpet backing.           acid, polymer with adipic
                                                                                acid and alkanediol.
P-16-0369............................       5/13/2016       8/11/2016  Allnex USA, Inc.........  (S) Ultra violet curable  (G) Substituted
                                                                                coating resin.            heteromonocycle, telomer
                                                                                with substituted
                                                                                carbomonocycles, substituted
                                                                                alkyl ester.
P-16-0370............................       5/13/2016       8/11/2016  CBI.....................  (G) Crosslinker for       (G) Polysiloxane with
                                                                                adhesives and coatings.   functional groups.
P-16-0371............................       5/13/2016       8/11/2016  CBI.....................  (G) Wetting and           (G) Polyphosphoric acids
                                                                                dispersing additive.      polyether polyethene alkyl
                                                                                alkyl.
P-16-0372............................       5/13/2016       8/11/2016  CBI.....................  (G) Wetting and           (G) Polyphosphoric acids
                                                                                dispersing additive.      polyether alkyl polyethylene
                                                                                polymer.
P-16-0373............................       5/13/2016       8/11/2016  CBI.....................  (S) Ultra violet          (G)
                                                                                absorber for plastic      Tris(alkyloxyphenyl)triazine
                                                                                articles.                 compounds.
P-16-0374............................       5/17/2016       8/15/2016  CBI.....................  (G) Oil additive........  (G) Metal branched alkyl
                                                                                substituted carbomonocycle
                                                                                complexes with substituted
                                                                                alkyl carbomonocycle.
P-16-0375............................       5/19/2016       8/17/2016  CBI.....................  (G) Binder for seal       (G) Alkyl methacrylates,
                                                                                application.              polymer with olefines.
P-16-0376............................       5/18/2016       8/16/2016  CBI.....................  (G) Photolithography....  (G) Hydroxystyrene resin.
P-16-0377............................       5/17/2016       8/15/2016  CBI.....................  (G) Film component......  (G) Polyester polyol.
P-16-0378............................       5/17/2016       8/15/2016  CBI.....................  (G) Film component......  (G) Polyester polyol.
P-16-0379............................       5/18/2016       8/16/2016  CBI.....................  (G) Intermediate for      (G) Vinyl functional
                                                                                polymer synthesis.        polymethylalkylpolymer.

P-16-0380............................       5/18/2016       8/16/2016  CBI.....................  (G) Component of          (G) Formic acid, compds. with
                                                                                electrocoat resin.        hydrolyzed bisphenol a-
                                                                                epichlorohydrin-polyethylene
                                                                                glycol ether with bisphenol
                                                                                a (2:1) polymer-n1-(1,3-
                                                                                dimethylbutylidene)-n2-[2-
                                                                                [(1, 3-
                                                                                dimethylbutylidene)amino]eth
                                                                                yl]-1,2-ethanediamine-
                                                                                dialdehyde-2-
                                                                                (methylamino)ethanol
                                                                                reaction products acetates
                                                                                (salts).
P-16-0381............................       5/18/2016       8/16/2016  CBI.....................  (G) Component of          (G) Propanoic acid, 2-hydroxy-
                                                                                electrocoat resin.        , compds. with hydrolyzed
                                                                                bisphenol a-epichlorohydrin-
                                                                                polyethylene glycol ether
                                                                                with bisphenol a (2:1)
                                                                                polymer-n1-(1,3-
                                                                                dimethylbutylidene)-n2-[2-
                                                                                [(1, 3-
                                                                                dimethylbutylidene)amino]eth
                                                                                yl]-1,2-ethanediamine-
                                                                                dialdehyde-2-
                                                                                (methylamino)ethanol
                                                                                reaction products formates
                                                                                (salts).
P-16-0381............................       5/18/2016       8/16/2016  CBI.....................  (S) Anti-crater additive  (G) Propanoic acid, 2-hydroxy-
                                                                                for automotive            , compds. with hydrolyzed
                                                                                electrocoat resin.        bisphenol a-epichlorohydrin-
                                                                                polyethylene glycol ether
                                                                                with bisphenol a (2:1)
                                                                                polymer-n1-(1,3-
                                                                                dimethylbutylidene)-n2-[2-
                                                                                [(1, 3-
                                                                                dimethylbutylidene)amino]eth
                                                                                yl]-1,2-ethanediamine-
                                                                                dialdehyde-2-
                                                                                (methylamino)ethanol
                                                                                reaction products formates
                                                                                (salts).
P-16-0382............................       5/18/2016       8/16/2016  CBI.....................  (G) Component of          (G) Formic acid, compds. with
                                                                                electrocoat resin.        hydrolyzed bisphenol a-
                                                                                epichlorohydrin-polyethylene
                                                                                glycol ether with bisphenol
                                                                                a (2:1) polymer-n1-(1,3-
                                                                                dimethylbutylidene)-n2-[2-
                                                                                [(1, 3-
                                                                                dimethylbutylidene)amino]eth
                                                                                yl]-1,2-ethanediamine-
                                                                                dialdehyde-2-
                                                                                (methylamino)ethanol
                                                                                reaction products sulfamates
                                                                                (salts).
P-16-0382............................       5/18/2016       8/16/2016  CBI.....................  (S) Anti-crater additive  (G) Formic acid, compds. with
                                                                                for automotive            hydrolyzed bisphenol a-
                                                                                electrocoat resin.        epichlorohydrin-polyethylene
                                                                                glycol ether with bisphenol
                                                                                a (2:1) polymer-n1-(1,3-
                                                                                dimethylbutylidene)-n2-[2-
                                                                                [(1, 3-
                                                                                dimethylbutylidene)amino]eth
                                                                                yl]-1,2-ethanediamine-
                                                                                dialdehyde-2-
                                                                                (methylamino)ethanol
                                                                                reaction products sulfamates
                                                                                (salts).
P-16-0383............................       5/18/2016       8/16/2016  CBI.....................  (S) Anti-crater additive  (G) Formic acid, compds. with
                                                                                for automotive            hydrolyzed bisphenol a-
                                                                                electrocoat resin.        epichlorohydrin-polyethylene
                                                                                glycol ether with bisphenol
                                                                                a (2:1) polymer-n1-(1,3-
                                                                                dimethylbutylidene)-n2-[2-
                                                                                [(1, 3-
                                                                                dimethylbutylidene)amino]eth
                                                                                yl]-1,2-ethanediamine-
                                                                                dialdehyde-2-
                                                                                (methylamino)ethanol
                                                                                reaction products acetates
                                                                                (salts).
P-16-0383............................       5/18/2016       8/16/2016  CBI.....................  (G) Component in          (G) Formic acid, compds. with
                                                                                electrocoat resin.        hydrolyzed bisphenol a-
                                                                                epichlorohydrin-polyethylene
                                                                                glycol ether with bisphenol
                                                                                a (2:1) polymer-n1-(1,3-
                                                                                dimethylbutylidene)-n2-[2-
                                                                                [(1, 3-
                                                                                dimethylbutylidene)amino]eth
                                                                                yl]-1,2-ethanediamine-
                                                                                dialdehyde-2-
                                                                                (methylamino)ethanol
                                                                                reaction products acetates
                                                                                (salts).

P-16-0384............................       5/18/2016       8/16/2016  CBI.....................  (G) Component of an       (G) Propanoic acid, 2-hydroxy-
                                                                                electrocoat resin.        , compds. with hydrolyzed
                                                                                bisphenol a-epichlorohydrin-
                                                                                polyethylene glycol ether
                                                                                with bisphenol a (2:1)
                                                                                polymer-n1-(1,3-
                                                                                dimethylbutylidene)-n2-[2-
                                                                                [(1, 3-
                                                                                dimethylbutylidene)amino]eth
                                                                                yl]-1,2-ethanediamine-
                                                                                dialdehyde-2-
                                                                                (methylamino)ethanol
                                                                                reaction products formates
                                                                                (salts).
P-16-0384............................       5/18/2016       8/16/2016  CBI.....................  (S) Anti-crater additive  (G) Propanoic acid, 2-hydroxy-
                                                                                for automotive            , compds. with hydrolyzed
                                                                                electrocoat resin.        bisphenol a-epichlorohydrin-
                                                                                polyethylene glycol ether
                                                                                with bisphenol a (2:1)
                                                                                polymer-n1-(1,3-
                                                                                dimethylbutylidene)-n2-[2-
                                                                                [(1, 3-
                                                                                dimethylbutylidene)amino]eth
                                                                                yl]-1,2-ethanediamine-
                                                                                dialdehyde-2-
                                                                                (methylamino)ethanol
                                                                                reaction products formates
                                                                                (salts).
P-16-0385............................       5/18/2016       8/16/2016  CBI.....................  (G) Component of          (G) Formic acid, compds. with
                                                                                electrocoat resin.        hydrolyzed bisphenol a-
                                                                                epichlorohydrin-polyethylene
                                                                                glycol ether with bisphenol
                                                                                a (2:1) polymer-n1-(1,3-
                                                                                dimethylbutylidene)-n2-[2-
                                                                                [(1, 3-
                                                                                dimethylbutylidene)amino]eth
                                                                                yl]-1,2-ethanediamine-
                                                                                dialdehyde-2-
                                                                                (methylamino)ethanol
                                                                                reaction products sulfamates
                                                                                (salts).
P-16-0385............................       5/18/2016       8/16/2016  CBI.....................  (S) Anti-crater additive  (G) Formic acid, compds. with
                                                                                for automotive            hydrolyzed bisphenol a-
                                                                                electrocoat resin.        epichlorohydrin-polyethylene
                                                                                glycol ether with bisphenol
                                                                                a (2:1) polymer-n1-(1,3-
                                                                                dimethylbutylidene)-n2-[2-
                                                                                [(1, 3-
                                                                                dimethylbutylidene)amino]eth
                                                                                yl]-1,2-ethanediamine-
                                                                                dialdehyde-2-
                                                                                (methylamino)ethanol
                                                                                reaction products sulfamates
                                                                                (salts).
P-16-0386............................       5/20/2016       8/18/2016  CBI.....................  (S) Additive for motor    (S) Hexanedioic acid, 1,6-
                                                                                oil formulations and      bis(3,5,5-trimethylhexyl)
                                                                                gear oil lubricants.      ester.
P-16-0388............................       5/20/2016       8/18/2016  CBI.....................  (G) Hardener for epoxy    (G) Aliphatic polyamines,
                                                                                coating.                  polymers with bisphenol a
                                                                                and epichlorohydrin.
P-16-0389............................       5/23/2016       8/21/2016  CBI.....................  (G) Oil & gas extraction  (G) Polymer of substituted
                                                                                acrylic acid,
                                                                                mercaptoethanol and
                                                                                bromohexane.
P-16-0390............................       5/27/2016       8/25/2016  CBI.....................  (S) Coating resin used    (G) Alkyl alkenoic acid alkyl
                                                                                in anti-fogging clear     ester polymer with alkyl
                                                                                coat applied to           alkenoate, dialkyl
                                                                                automotive parts.         alkenamide, hydroxy-modified
                                                                                alkenoic acid derivative,
                                                                                and sulfonic-modified
                                                                                alkenoic acid derivative.
P-16-0391............................       5/23/2016       8/21/2016  CBI.....................  (G) Stabilizer..........  (G) Polyester polyol polymer
                                                                                with aliphatic isocyanate
                                                                                and phenol derivates.
P-16-0392............................       5/25/2016       8/23/2016  CBI.....................  (G) Wax.................  (G) Modified vegetable oil.
P-16-0394............................       5/31/2016       8/29/2016  CBI.....................  (G) Adhesive............  (G) Benzenedicarboxylic acid,
                                                                                polymer with decanedioic
                                                                                acid and dodecanedioic acid,
                                                                                ethanediol, hexanedioic
                                                                                acid, hexanediol, alpha-
                                                                                hydro-omega-
                                                                                hydroxypoly[oxy(methyl-1,2-
                                                                                ethanediyl)],
                                                                                isobenzofurandione,1,1'-
                                                                                methylenebis[4-
                                                                                isocyanatobenzene], phenol
                                                                                and trimethylbicyclo hept-2-
                                                                                ene.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    For the 28 NOCs received by EPA during this period, Table 3
provides the following information (to the extent that such information
is not claimed as CBI): The EPA case number assigned to the NOC; the
date the NOC was received by EPA; the projected date of commencement
provided by the submitter in the NOC; and the chemical identity.

                             Table 2--NOCs Received From May 2, 2016 to May 31, 2016
----------------------------------------------------------------------------------------------------------------
                                                              Projected end
                 Case No.                    Date received       date of               Chemical identity
                                                               commencement
----------------------------------------------------------------------------------------------------------------
P-89-1056.................................        5/9/2016          8/31/2005  (G) Polyurethane.
P-92-0303.................................        5/6/2016          6/23/1992  (S) Phenol, 2,4,6-
                                                                                tris[(dimethylamino)methyl]-,
                                                                                reaction products with benzyl
                                                                                chloride.
P-99-0096.................................        5/6/2016           5/4/2016  (G) Amine-modified polyether
                                                                                acrylate.
P-13-0916.................................       5/10/2016          4/17/2016  (G) Polyurethane.
P-14-0076.................................        5/5/2016         11/18/2014  (G) Synthetic polyol esters.
P-14-0078.................................        5/5/2016          9/11/2014  (G) Synthetic polyol ester.
P-14-0079.................................        5/5/2016          6/26/2014  (G) Synthetic polyol esters.
P-14-0711.................................       5/10/2016           5/3/2016  (G) Polyurethane.
P-14-0855.................................       5/10/2016          4/18/2016  (G) Polyurethane.
P-14-0856.................................       5/10/2016          4/18/2016  (G) Polyurethane.
P-14-0857.................................       5/10/2016          4/18/2016  (G) Polyurethane.
P-14-0858.................................       5/10/2016          4/18/2016  (G) Polyurethane.
P-15-0120.................................       5/11/2016          2/24/2016  (G) Substituted benzyl acrylate.
P-15-0276.................................       5/23/2016           5/2/2016  (G) Functionalized carbon
                                                                                nanotubes.
P-15-0303.................................       5/19/2016          5/17/2016  (S) Cellulose, carboxymethyl
                                                                                ether, sodium salt, polymer with
                                                                                bis(isocyanatomethyl)benzene,
                                                                                2,2-dimethoxyacetaldehyde,
                                                                                ethanedial, 2-ethyl-2-
                                                                                (hydroxymethyl)-1,3-propanediol,
                                                                                2-oxoacetic acid, 1h-1,2,4-
                                                                                triazole-3,5-diamine and 1,3,5-
                                                                                triazine-2,4,6-triamine.
P-15-0747.................................       5/26/2016          5/13/2016  (G) Naturally-occurring minerals,
                                                                                reaction products with boron
                                                                                sodium oxide (b4na2o7), hetero
                                                                                substituted alkyl acrylate
                                                                                polymer, kaolin and sodium
                                                                                silicate.
P-16-0056.................................       5/26/2016           5/5/2016  (G) Dialkyl fattyalkylamino
                                                                                propanamide alkylamine acetates.
P-16-0124.................................       5/13/2016           5/1/2016  (G) Substituted alkanoic acid-,
                                                                                salts with substituted alkanol-
                                                                                blocked haloalkyl
                                                                                heteromonocycle substituted
                                                                                carbomonocycle polymer alkyl
                                                                                alkanoate substituted
                                                                                carbomonocycle-
                                                                                trialkylcarbomonocycle-alkyl
                                                                                imine reaction products.
P-16-0126.................................       5/13/2016           5/1/2016  (G) Substituted carbomonocycle,
                                                                                polymer with substituted
                                                                                heteromonocycle, reaction
                                                                                products with substituted amine,
                                                                                substituted amine and
                                                                                substituted alkanol,
                                                                                alkylalkanoates substituted
                                                                                carbomonocycle.
P-16-0135.................................        5/2/2016          4/14/2016  (G) Polyesters, fatty alkyl
                                                                                amindes terminated.
P-16-0141.................................        5/4/2016           5/1/2016  (G) Polyalkyl methacrylate
                                                                                copolymer.
P-16-0190.................................       5/20/2016          4/25/2016  (G) Aryl polyolefin.
P-16-0210.................................       5/23/2016          5/11/2016  (G) Alkanepolycarboxylic acids,
                                                                                polymer with alkanepolyols,
                                                                                benzenedicarboxylic acid,
                                                                                methylenebis[isocyantobenzene],
                                                                                mono- and polyether polyols,
                                                                                benzenedicarboxylic acid
                                                                                derivative and caprolactone.
P-16-0210.................................       5/23/2016          5/12/2016  (G) Alkanepolycarboxylic acids,
                                                                                polymer with alkanepolyols,
                                                                                benzenedicarboxylic acid,
                                                                                methylenebis[isocyantobenzene],
                                                                                mono- and polyether polyols,
                                                                                benzenedicarboxylic acid
                                                                                derivative and caprolactone.
P-16-0211.................................       5/23/2016          5/13/2016  (G) Polymer of alkyl acrylate,
                                                                                caprolactone,
                                                                                methylenebis[isocyanatobenzene],
                                                                                alkyl methacrylates, polyether
                                                                                polyol, alkanepolycarboxylic
                                                                                acid, substituted methacrylate
                                                                                and alkanepolyol.
P-16-0212.................................       5/23/2016          5/17/2016  (G) Polymer of alkanepolyols,
                                                                                methylenebis[isocyantobenzene],
                                                                                polyether polyol, alkyl
                                                                                methacrylates and acrylate,
                                                                                methacrylic acid, substitued
                                                                                methacrylic acid and
                                                                                alkanepolycarboxylic acid.
P-16-0213.................................       5/23/2016          5/10/2016  (G) Polymer of substituted
                                                                                benzenes, alkanepolyols,
                                                                                alkanepolycarboxylic acids,
                                                                                methylenebis[isocyanatobenzene],
                                                                                polyether polyol, neopentyl
                                                                                glycol and a substituted glycol.
P-16-0214.................................       5/23/2016          5/10/2016  (G) Polyether polyols, polymers
                                                                                with substituted benzenes,
                                                                                methylenebis[isocyanatobenzene],
                                                                                alkanepolyols, caprolactone and
                                                                                a substituted glycol.
----------------------------------------------------------------------------------------------------------------

    Authority:  15 U.S.C. 2601 et seq.

    Dated: July 5, 2016.
Pamela S. Myrick,
Acting Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2016-16448 Filed 7-11-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 195 (Friday, October 7, 2011)]
[Notices]
[Pages 62484-62486]
[FR Doc No: 2011-25957]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65467; File No. SR-NASDAQ-2011-136]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Modify NASDAQ Options Market Rules Chapter VII, Section 6, Market Maker
Quotations

October 3, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934

(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 28, 2011, The NASDAQ Stock Market LLC (``NASDAQ'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by NASDAQ. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

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

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

    NASDAQ is filing a proposal for the NASDAQ Options Market (``NOM'')
to amend Chapter VII, Section 6, Market Maker Quotations, to permit
wider bid/ask differentials to correspond to the width of the market in
the underlying security, as described below.
    The text of the proposed rule change is available at
nasdaq.cchwallstreet.com, at NASDAQ'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, NASDAQ included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. NASDAQ has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    The purpose of the proposed rule change is to modify recently-
adopted bid/ask differentials. The new bid/ask differentials, also
known as quotation spread parameters, establish the maximum permissible
width between a Market Maker's bid and an offer in a particular series.
Recently, NASDAQ adopted a $5 wide quote spread parameters for all
options.\3\ Previously, there was no quote spread requirement and
NASDAQ adopted the $5 wide requirement in order to encourage narrower
markets and thereby improve the quality of NOM's markets.
---------------------------------------------------------------------------

    \3\ See NOM Rules, Chapter VII, Section 6(d)(ii). Securities
Exchange Act Release No. 64054 (March 8, 2011), 76 FR 14111 (March
15, 2011).
---------------------------------------------------------------------------

    At this time, NASDAQ proposes to permit wider bid/ask differentials
to correspond to the width of the market in the underlying security.
Specifically, NASDAQ proposes to amend Chapter VII, Section 6, Market
Maker Quotations, to provide that respecting in-the-money series \4\
where the market for the underlying security is wider than $5, the bid/
ask differential may be as wide as the quotation for the underlying
security on the primary market.\5\ For instance, under the current
rule, where the market for the underlying security in the primary
market is $60-$70, the applicable quote spread parameter is $5, but
under the proposed language, it would be $10 for the in-the-money
series, which is the spread in the underlying security in the primary
market. NASDAQ believes that this is appropriate because options are
priced relative to the price of the security underlying that option and
are often hedged with the underlying security as well; accordingly, the
price of an in-the-money option is particularly constrained by a quote
spread parameter requirement that does not take into account a quote
spread in the underlying security greater than $5.
---------------------------------------------------------------------------

    \4\ In-the-money series are those series, where, in the case of
call options, the current market price of the underlying security is
higher than the strike price, or, in the case of put options, the
current market price of the underlying security is lower than the
strike price.
    \5\ Primary market is defined in Chapter I, Section 1(a)(47) as,
in the case of securities listed on Nasdaq, the market that is
identified as the listing market pursuant to Section X(d) of the
approved national market system plan governing the trading of
Nasdaq-listed securities, and, in the case of securities listed on
another national securities exchange, the market that is identified
as the listing market pursuant to Section XI of the Consolidated
Tape association Plan.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \6\ in general, and furthers the objectives of Section
6(b)(5) of the Act \7\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanisms of a free and open
market and a national market system, and, in general, to protect
investors and the public interest because it will help conform NOM's
rules to those of other exchanges, as described below, which should, in
term, avoid confusion and promote competition among exchanges.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing 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 after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to Section 19(b)(3)(A) of the Act \8\ and Rule 19b-4(f)(6) \9\
thereunder.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file 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 satisfied 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. 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2011-136 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-NASDAQ-2011-136. 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 on
official business days between the hours of 10 a.m. and 3 p.m. Copies
of such filing also will be available for inspection and copying at the
principal offices 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-NASDAQ-2011-136, and should be submitted on or before
October 28, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-25957 Filed 10-6-11; 8:45 am]
BILLING CODE 8011-01-P


    	U. S. Environmental Protection Agency

Office of Prevention, Pesticides, and Toxic Substances (OPPTS)

1200 Pennsylvania Avenue, NW

Washington, DC  20460

Docket Verification and Certification Form

For Internal OPPTS Use Only

Title of Action:	Notice of Filing of a Pesticide Petition for the
Establishment of Tolerances for Residues of Thiamethoxam in Food/Feed
Handling Areas of Food/Feed Handling Establishments

RIN #:   	Docket ID #:     EPA-HQ-OPP-2010-0602	FRL#:

Docket Title:	Thiamethoxam; Food/Feed Handling Areas of Food/Feed
Handling Establishments

Contact Information:	Name:	Kable Bo Davis	Phone #:<PHONE_NUMBER>

Legacy Information:

	Program Lead’s Verification:    I have reviewed the docket and
verified the following:

All of the documents identified in the attached Docket Index have been
submitted to the appropriate Docket Manager for inclusion in the docket
identified above.

Documents containing copyrighted, CBI, or otherwise protected
information have been identified to allow for “special” processing
by the appropriate Docket Staff.

The material has been assembled in a useable form to support the
document being published in the FEDERAL REGISTER (FR).

COMMENTS:

.Date:   07/14/10	Initials:  Kable Bo Davis	Phone #:<PHONE_NUMBER>

Docket Manager’s Verification and Sign-off:   I hereby confirm the
following:

The Docket ID # identified above matches our records.

The documents identified in the attached Docket Index have been received
by the OPP Docket Staff.

The documents have been properly processed for inclusion in EPA FDMS
Dockets, as appropriate.

The documents either already are in the docket or are being processed
for inclusion in the docket.

COMMENTS:

Date:   	Signature:	Phone #:

Program Lead’s Certification:   I hereby certify that:

I have completed the verification above.

I have submitted to the Docket Manager all of the documents that I
identified needed to be updated or added to the docket.

I have obtained the Docket Manager’s sign-off.

The docket is complete and ready for public release.

COMMENTS:

Date:   07/14/10 	Signature:    Kable Bo Davis	Phone #:<PHONE_NUMBER>

Attachment:    List of Documents for Docket ID # EPA-HQ-2010-0602 as of
July 14, 2010

Document Title	Source Information:  Author (Last, First Name);
Organization; Citation	Date of Document	1)  CBI     2) Other Protected,
e.g., Studies

3)  Copyrighted

	Notice of Filing of a Pesticide Petition for the Establishment of
Tolerances for Residues of Thiamethoxam in Food/Feed Handling Areas of
Food/Feed Handling Establishments	Syngenta Crop Protection

P.O. Box 18300

Greensboror, NC 27419

N/A


[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Pages 60021-60022]
[FR Doc No: 2017-27156]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6617]

Developing Targeted Therapies in Low-Frequency Molecular Subsets
of a Disease; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Developing
Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.''
The purpose of this guidance is to describe the FDA's current
recommendations on how to group patients with different molecular
alterations for eligibility in clinical trials; and general approaches
to evaluating the benefits and risks of targeted therapeutics within a
clinically defined disease where some molecular alterations may occur
at low frequencies.

DATES: Submit either electronic or written comments on the draft
guidance by February 16, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6617 for ``Developing Targeted Therapies in Low-Frequency
Molecular Subsets of a Disease.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Michael Pacanowski, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 301-
796-3919; 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

    FDA is announcing the availability of a draft guidance for industry
entitled ``Developing Targeted Therapies in Low-Frequency Molecular
Subsets of a Disease.'' This guidance is intended to assist sponsors in
designing drug development programs to generate the evidence needed to
demonstrate efficacy of a targeted therapy across subsets of patients
with different underlying molecular alterations within a disease, where
some molecular alterations may occur at low frequencies.
    In recent years, advances in our understanding of the molecular
pathology of many diseases have led to the development of targeted
therapies. Although variability in drug response has long been
recognized in drug development, targeted therapies present new
challenges in addressing the heterogeneity in drug response because the
pharmacological effect of a targeted therapy is often related to a
particular molecular alteration (e.g., a mutation, gene fusion,
epigenetic change, etc.). Many clinically defined diseases are caused
by a range of different molecular alterations, some of which may occur
at low frequencies, that impact a common protein or pathway involved in
the disease pathogenesis. In a population of patients with the same
clinical disease, the heterogeneity in the molecular etiology may
result in different responses to a particular therapy. However, certain
targeted therapies may be effective in multiple groups of patients that
have different underlying molecular alterations. Therefore, FDA is
providing guidance on the type and quantity of evidence that can
demonstrate efficacy across molecular subsets within a disease.
    This guidance addresses the following important topics in
evaluating the benefits and risks of targeted therapeutics within a
disease where some molecular alterations may occur at low frequencies:

 Identification of patients for inclusion in clinical trials
 Interpretation of study results and generalizability of
findings
 Benefit-risk determination and therapeutic product labeling
 Refining the indicated population after the initial approval
    In addition to comments on the general content of the draft
guidance, FDA requests input on whether the principles described for
grouping molecular subsets for clinical trial enrollment should be
limited to diseases with low-frequency molecular alterations or whether
they could be broadly applicable to all targeted therapies.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Developing
Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.''
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations. This
guidance is not subject to Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: December 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27156 Filed 12-15-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 173 (Friday, September 6, 2019)]
[Notices]
[Pages 47043-47045]
[FR Doc No: 2019-19263]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0386]

Qualification of Drivers; Exemption Applications; Hearing

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

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew exemptions for 2
individuals from the hearing requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these hard of hearing and deaf
individuals to continue to operate CMVs in interstate commerce.

DATES: The exemptions were applicable on September 12, 2019. The
exemptions expire on September 12, 2021.

Comments must be received on or before October 7, 2019.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket No. FMCSA-2014-0386, using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/docket?D=FMCSA-2014-0386. Follow the online
instructions for submitting comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

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

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2014-0386), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so that FMCSA can contact you if there are questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov/docket?D=FMCSA-2014-0386. Click on the ``Comment Now!'' button and type
your comment into the text box on the following screen. Choose whether
you are submitting your comment as an individual or on behalf of a
third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov/docket?D=FMCSA-2014-0386 and choose the document to review. If you do
not have access to the internet, you may view the docket online by
visiting the Docket Management Facility in Room W12-140 on the ground
floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington,
DC 20590, between 9 a.m. and 5 p.m., ET, Monday through Friday, except
Federal holidays.

C. Privacy Act

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

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The physical qualification standard for drivers regarding hearing
found in 49 CFR 391.41(b)(11) states that a person is physically
qualified to drive a CMV if that person first perceives a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a
hearing aid when the audiometric device is calibrated to American
National Standard (formerly ASA Standard) Z24.5-1951.
    This standard was adopted in 1970 and was revised in 1971 to allow
drivers to be qualified under this standard while wearing a hearing
aid, 35 FR 6458, 6463 (April 22, 1970) and 36 FR 12857 (July 3, 1971).
    The 2 individuals listed in this notice have requested renewal of
their exemptions from the hearing standard in Sec.  391.41(b)(11), in
accordance with FMCSA procedures. Accordingly, FMCSA has evaluated
these applications for renewal on their merits and decided to extend
each exemption for a renewable 2-year period.

III. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315(b), FMCSA will take immediate steps to revoke the
exemption of a driver.

IV. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the 2
applicants has satisfied the renewal conditions for obtaining an
exemption from the hearing requirement. The 2 drivers in this notice
remain in good standing with the Agency. In addition, for Commercial
Driver's License (CDL) holders, the Commercial Driver's License
Information System and the Motor Carrier Management Information System
are searched for crash and violation data. For non-CDL holders, the
Agency reviews the driving records from the State Driver's Licensing
Agency. These factors provide an adequate basis for predicting each
driver's ability to continue to safely operate a CMV in interstate
commerce. Therefore, FMCSA concludes that extending the exemption for
each of these drivers for a period of 2 years is likely to achieve a
level of safety equal to that existing without the exemption. As of
September 12, 2019, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following 2 individuals have satisfied the renewal

conditions for obtaining an exemption from the hearing requirement in
the FMCSRs for interstate CMV drivers:
    Eduwin Pineiro (NJ); and Casey Wayne Patrick (WA).
    The drivers were included in docket number FMCSA-2014-0386. Their
exemptions are applicable as of September 12, 2019 and will expire on
September 12, 2021.

V. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must report any crashes or accidents as defined in
Sec.  390.5; and (2) report all citations and convictions for
disqualifying offenses under 49 CFR 383 and 49 CFR 391 to FMCSA; and
(3) each driver prohibited from operating a motorcoach or bus with
passengers in interstate commerce. The driver must also have a copy of
the exemption when driving, for presentation to a duly authorized
Federal, State, or local enforcement official. In addition, the
exemption does not exempt the individual from meeting the applicable
CDL testing requirements. Each exemption will be valid for 2 years
unless rescinded earlier by FMCSA. The exemption will be rescinded if:
(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 before it was granted; or (3) continuation of the
exemption would not be consistent with the goals and objectives of 49
U.S.C. 31136 and 31315(b).

VI. Preemption

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

VII. Conclusion

    Based upon its evaluation of the 2 exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the hearing
requirement in Sec.  391.41 (b)(11). In accordance with 49 U.S.C.
31136(e) and 31315(b), each exemption will be valid for two years
unless revoked earlier by FMCSA.

    Issued on: August 29, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-19263 Filed 9-5-19; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 88, Number 54 (Tuesday, March 21, 2023)]
[Notices]
[Page 17082]
[FR Doc No: 2023-05695]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2022-0133]

Agency Information Collection Activities: Request for Comments;
Renewal of a Previously Approved Information Collection: U.S.
Department of Transportation, Individual Complaint of Employment
Discrimination Form

AGENCY: Office of the Secretary, U.S. Department of Transportation.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this
notice announces that the U.S. Department of Transportation (DOT) will
forward the Information Collection Request (ICR) abstracted below to
the Office of Management and Budget (OMB) for renewal of a previously
approved collection. The ICR describes the nature of the information
collection and its expected cost and burden hours. The OMB approved the
form in 2020 with its renewal required by April 30, 2023. The Federal
Register Notice with a 60-day comment period soliciting comments on the
form renewal was published on November 18, 2022 [FR Vol. 87, No. 222,
page 69386]. No comments were received.

DATES: Comments on this notice are due by April 16, 2023.

FOR FURTHER INFORMATION CONTACT: Barbara Dougherty, Deputy Director,
Departmental Office of Civil Rights, U.S. Department of Transportation,
1200 New Jersey Avenue SE, Washington, DC 20590,<PHONE_NUMBER> (office),
[email protected].

SUPPLEMENTARY INFORMATION:
    Title: Individual Complaint of Employment Discrimination Form.
    Form Number: DOT-F 1050-8. OMB Control Number: 2105-0556.
    Type of Request: Renewal of a previously approved collection.
    Abstract: DOT will utilize the form to collect information
necessary to process EEO discrimination complaints filed by individuals
who are Federal employees, former employees or applicants for
employment with the Department. These complaints are processed in
accordance with the U.S. Equal Employment Opportunity Commission's
regulations, Title 29, Code of Federal Regulations, Part 1614, as
amended. DOT will use the form to: (a) Request requisite information
from the applicant for processing his/her EEO discrimination complaint;
and (b) obtain information to identify an individual or his or her
attorney or other representative, if appropriate. An applicant's filing
of an EEO discrimination complaint is solely voluntary. The DOT
estimates that it takes an applicant approximately one hour to complete
the form.
    Affected Public: Federal employees, former employees, or applicants
for employment with the Department.
    Estimated Number of Respondents: 275 per year.
    Estimated Total Annual Estimated Burden: 275 hours.
    Frequency of Collection: An individual's filing of an EEO complaint
is solely voluntary.

ADDRESSES: Send comments regarding the burden estimate, including
suggestions for reducing the burden, to the Office of Management and
Budget, Attention: Desk Officer for the Office of the Secretary of
Transportation, 725 17th Street NW, Washington, DC 20503.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology. All responses to this notice will be summarized
and included in the request for Office of Management and Budget
approval. All comments will also become a matter of public record.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter
35, as amended; and 49 CFR 1:48.

    Issued in Washington, DC, on March 15, 2023.
Barbara Dougherty,
Deputy Director, Departmental Office of Civil Rights, U.S. Department
of Transportation.
[FR Doc. 2023-05695 Filed 3-20-23; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 84, Number 202 (Friday, October 18, 2019)]
[Notices]
[Page 55993]
[FR Doc No: C1-2019-21473]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87143; File No. SR-CboeEDGA-2019-014]

Self-Regulatory Organizations; Cboe EDGA Exchange, Inc.;
Suspension of and Order Instituting Proceedings To Determine Whether To
Approve or Disapprove a Proposed Rule Change Amending the Fee Schedule
Assessed on Members To Establish a Monthly Trading Rights Fee

September 27, 2019.

Correction

    In Notice document 201-21473, appearing on pages 52922-52925, in
the issue of Thursday, October 3, 2019, make the following correction:
    On page 52925, in the second column, beginning on the eighth line,
the date reading ``November 6, 2019'' should read November 7, 2019''.

[FR Doc. C1-2019-21473 Filed 10-17-19; 8:45 am]
BILLING CODE 1301-00-D