[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)]
[Notices]
[Pages 79020-79027]
[FR Doc No: 2016-27195]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0484; FRL-9954-52]

Certain New Chemicals; Receipt and Status Information for
September 2016

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

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

September 1, 2016 to September 30, 2016.

DATES: Comments identified by the specific case number provided in this
document, must be received on or before December 12, 2016.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2016-0484, 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:
(202) 564-8593; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. 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 September 1, 2016 to September 30, 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, please 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 71 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 September 1, 2016 to September 30, 2016
----------------------------------------------------------------------------------------------------------------
                                          Projected
       Case No.         Received date    notice end         Manufacturer             Use            Chemical
                                            date              importer
----------------------------------------------------------------------------------------------------------------
P-16-0379............       9/26/2016      12/25/2016  CBI..................  (G) Intermediate  (G) Vinyl
                                                                               for polymer       functional
                                                                               synthesis.        polymethylalkyl
                                                                                polymer.
P-16-0399............       9/16/2016      12/15/2016  Tryeco LLC...........  (S) Compound to   (S) Starch,
                                                                               be used in        polymer with 2-
                                                                               preparation of    propenoic acid,
                                                                               advanced seed     potassium salt.
                                                                               coatings.         oxidized.

P-16-0399............       9/16/2016      12/15/2016  Tryeco LLC...........  (S) Agricultural  (S) Starch,
                                                                               soil amendment    polymer with 2-
                                                                               for turf          propenoic acid,
                                                                               applications      potassium salt.
                                                                               and direct soil   oxidized.
                                                                               injection with
                                                                               fertilizers.
P-16-0399............       9/16/2016      12/15/2016  Tryeco LLC...........  (S) Agricultural  (S) Starch,
                                                                               soil amendment    polymer with 2-
                                                                               for filed crops   propenoic acid,
                                                                               as ``agrisorb     potassium salt.
                                                                               plus'' granular   oxidized.
                                                                               soil amendment.
P-16-0429............       9/20/2016      12/19/2016  CBI..................  (G) Universal     (G) Endcapped
                                                                               tint paste        polysiloxane.
                                                                               resin having
                                                                               high solids.
P-16-0460............       9/28/2016      12/27/2016  CBI..................  (G) Process aid.  (G) Silane-
                                                                                treated
                                                                                aluminosilicate
                                                                                .
P-16-0461............       9/28/2016      12/27/2016  CBI..................  (G) Process aid.  (G) Silane-
                                                                                treated
                                                                                aluminosilicate
                                                                                .
P-16-0462............       9/28/2016      12/27/2016  CBI..................  (G) Process aid.  (G) Silane-
                                                                                treated
                                                                                aluminosilicate
                                                                                .
P-16-0463............       9/28/2016      12/27/2016  CBI..................  (G) Process aid.  (G) Silane-
                                                                                treated
                                                                                aluminosilicate
                                                                                .
P-16-0464............       9/28/2016      12/27/2016  CBI..................  (G) Process aid.  (G) Silane-
                                                                                treated
                                                                                aluminosilicate
                                                                                .
P-16-0487............       9/22/2016      12/21/2016  Jaychem LLC..........  (S) Mass          (G)
                                                                               coloration of     Benzenesulfonic
                                                                               paper.            acid 1,2-
                                                                                diazenediylbis[
                                                                                6-ethenyl]-3-
                                                                                sulfophenyl
                                                                                diazenyl-2-
                                                                                sulfophenyl
                                                                                ethenyl salt.
P-16-0520............       9/26/2016      12/25/2016  CBI..................  (G) As described  (G) 2-propenoic
                                                                               above, the        acid, polymer
                                                                               notified          with N-(alkyl)-
                                                                               polymer will be   2propenamide,
                                                                               use as a          sodium alkyl
                                                                               pigment           alkene
                                                                               dispersant.       sulfonate (1:1)
                                                                                and sodium 2-
                                                                                methyl-2-[(1-
                                                                                oxo-2-propen-1-
                                                                                yl) amino]-1-
                                                                                propanesulfonat
                                                                                e (1:1),
                                                                                peroxydisulfuri
                                                                                c acid
                                                                                ([(ho)s(o)2]2o2
                                                                                ) sodium salt
                                                                                (1:2)-
                                                                                initiated.
P-16-0520............       9/26/2016      12/25/2016  CBI..................  (G) The           (G) 2-propenoic
                                                                               anticipated use   acid, polymer
                                                                               is as a deposit   with N-(alkyl)-
                                                                               control agent     2propenamide,
                                                                               and pigment       sodium alkyl
                                                                               dispersant.       alkene
                                                                                sulfonate (1:1)
                                                                                and sodium 2-
                                                                                methyl-2-[(1-
                                                                                oxo-2-propen-1-
                                                                                yl) amino]-1-
                                                                                propanesulfonat
                                                                                e (1:1),
                                                                                peroxydisulfuri
                                                                                c acid
                                                                                ([(ho)s(o)2]2o2
                                                                                ) sodium salt
                                                                                (1:2)-
                                                                                initiated.
P-16-0520............       9/26/2016      12/25/2016  CBI..................  (G) The           (G) 2-propenoic
                                                                               anticipated use   acid, polymer
                                                                               is as a pigment   with N-(alkyl)-
                                                                               dispersant.       2propenamide,
                                                                                sodium alkyl
                                                                                alkene
                                                                                sulfonate (1:1)
                                                                                and sodium 2-
                                                                                methyl-2-[(1-
                                                                                oxo-2-propen-1-
                                                                                yl) amino]-1-
                                                                                propanesulfonat
                                                                                e (1:1),
                                                                                peroxydisulfuri
                                                                                c acid
                                                                                ([(ho)s(o)2]2o2
                                                                                ) sodium salt
                                                                                (1:2)-
                                                                                initiated.
P-16-0520............       9/26/2016      12/25/2016  CBI..................  (G) The           (G) 2-propenoic
                                                                               anticipated use   acid, polymer
                                                                               is as a deposit   with N-(alkyl)-
                                                                               control agent.    2propenamide,
                                                                                sodium alkyl
                                                                                alkene
                                                                                sulfonate (1:1)
                                                                                and sodium 2-
                                                                                methyl-2-[(1-
                                                                                oxo-2-propen-1-
                                                                                yl) amino]-1-
                                                                                propanesulfonat
                                                                                e (1:1),
                                                                                peroxydisulfuri
                                                                                c acid
                                                                                ([(ho)s(o)2]2o2
                                                                                ) sodium salt
                                                                                (1:2)-
                                                                                initiated.
P-16-0521............       9/26/2016      12/25/2016  CBI..................  (G) The           (G) 2-propenoic
                                                                               anticipated use   acid, polymer
                                                                               is as a deposit   with N-(alkyl)-
                                                                               control agent.    2propenamide,
                                                                                sodium alkyl
                                                                                alkene
                                                                                sulfonate (1:1)
                                                                                and sodium 2-
                                                                                methyl-2-[(1-
                                                                                oxo-2-propen-1-
                                                                                yl) amino]-1-
                                                                                propanesulfonat
                                                                                e (1:1),
                                                                                potassium salt,
                                                                                peroxydisulfuri
                                                                                c acid
                                                                                ([(ho)s(o)2]2o2
                                                                                ) sodium salt
                                                                                (1:2)-
                                                                                initiated.

P-16-0521............       9/26/2016      12/25/2016  CBI..................  (G) As described  (G) 2-propenoic
                                                                               above, the        acid, polymer
                                                                               notified          with N-(alkyl)-
                                                                               polymer will be   2propenamide,
                                                                               use as a          sodium alkyl
                                                                               pigment           alkene
                                                                               dispersant.       sulfonate (1:1)
                                                                                and sodium 2-
                                                                                methyl-2-[(1-
                                                                                oxo-2-propen-1-
                                                                                yl) amino]-1-
                                                                                propanesulfonat
                                                                                e (1:1),
                                                                                potassium salt,
                                                                                peroxydisulfuri
                                                                                c acid
                                                                                ([(ho)s(o)2]2o2
                                                                                ) sodium salt
                                                                                (1:2)-
                                                                                initiated.
P-16-0521............       9/26/2016      12/25/2016  CBI..................  (G) The           (G) 2-propenoic
                                                                               anticipated use   acid, polymer
                                                                               is as a deposit   with N-(alkyl)-
                                                                               control agent     2propenamide,
                                                                               and pigment       sodium alkyl
                                                                               dispersant.       alkene
                                                                                sulfonate (1:1)
                                                                                and sodium 2-
                                                                                methyl-2-[(1-
                                                                                oxo-2-propen-1-
                                                                                yl) amino]-1-
                                                                                propanesulfonat
                                                                                e (1:1),
                                                                                potassium salt,
                                                                                peroxydisulfuri
                                                                                c acid
                                                                                ([(ho)s(o)2]2o2
                                                                                ) sodium salt
                                                                                (1:2)-
                                                                                initiated.
P-16-0521............       9/26/2016      12/25/2016  CBI..................  (G) The           (G) 2-propenoic
                                                                               anticipated use   acid, polymer
                                                                               is as a pigment   with N-(alkyl)-
                                                                               dispersant.       2propenamide,
                                                                                sodium alkyl
                                                                                alkene
                                                                                sulfonate (1:1)
                                                                                and sodium 2-
                                                                                methyl-2-[(1-
                                                                                oxo-2-propen-1-
                                                                                yl) amino]-1-
                                                                                propanesulfonat
                                                                                e (1:1),
                                                                                potassium salt,
                                                                                peroxydisulfuri
                                                                                c acid
                                                                                ([(ho)s(o)2]2o2
                                                                                ) sodium salt
                                                                                (1:2)-
                                                                                initiated.
P-16-0522............       9/26/2016      12/25/2016  CBI..................  (G) As described  (G) 2-propenoic
                                                                               above, the        acid, polymer
                                                                               notified          with N-(alkyl)-
                                                                               polymer will be   2propenamide,
                                                                               use as a          sodium alkyl
                                                                               pigment           alkene
                                                                               dispersant.       sulfonate (1:1)
                                                                                and sodium 2-
                                                                                methyl-2-[(1-
                                                                                oxo-2-propen-1-
                                                                                yl) amino]-1-
                                                                                propanesulfonat
                                                                                e (1:1), sodium
                                                                                salt,
                                                                                peroxydisulfuri
                                                                                c acid
                                                                                ([(ho)s(o)2]2o2
                                                                                ) sodium salt
                                                                                (1:2)-
                                                                                initiated.
P-16-0522............       9/26/2016      12/25/2016  CBI..................  (G) The           (G) 2-propenoic
                                                                               anticipated use   acid, polymer
                                                                               is as a pigment   with N-(alkyl)-
                                                                               dispersant.       2propenamide,
                                                                                sodium alkyl
                                                                                alkene
                                                                                sulfonate (1:1)
                                                                                and sodium 2-
                                                                                methyl-2-[(1-
                                                                                oxo-2-propen-1-
                                                                                yl) amino]-1-
                                                                                propanesulfonat
                                                                                e (1:1), sodium
                                                                                salt,
                                                                                peroxydisulfuri
                                                                                c acid
                                                                                ([(ho)s(o)2]2o2
                                                                                ) sodium salt
                                                                                (1:2)-
                                                                                initiated.
P-16-0522............       9/26/2016      12/25/2016  CBI..................  (G) The           (G) 2-propenoic
                                                                               anticipated use   acid, polymer
                                                                               is as a deposit   with N-(alkyl)-
                                                                               control agent     2propenamide,
                                                                               and pigment       sodium alkyl
                                                                               dispersant.       alkene
                                                                                sulfonate (1:1)
                                                                                and sodium 2-
                                                                                methyl-2-[(1-
                                                                                oxo-2-propen-1-
                                                                                yl) amino]-1-
                                                                                propanesulfonat
                                                                                e (1:1), sodium
                                                                                salt,
                                                                                peroxydisulfuri
                                                                                c acid
                                                                                ([(ho)s(o)2]2o2
                                                                                ) sodium salt
                                                                                (1:2)-
                                                                                initiated.
P-16-0522............       9/26/2016      12/25/2016  CBI..................  (G) The           (G) 2-propenoic
                                                                               anticipated use   acid, polymer
                                                                               is as a deposit   with N-(alkyl)-
                                                                               control agent.    2propenamide,
                                                                                sodium alkyl
                                                                                alkene
                                                                                sulfonate (1:1)
                                                                                and sodium 2-
                                                                                methyl-2-[(1-
                                                                                oxo-2-propen-1-
                                                                                yl) amino]-1-
                                                                                propanesulfonat
                                                                                e (1:1), sodium
                                                                                salt,
                                                                                peroxydisulfuri
                                                                                c acid
                                                                                ([(ho)s(o)2]2o2
                                                                                ) sodium salt
                                                                                (1:2)-
                                                                                initiated.

P-16-0523............       9/26/2016      12/25/2016  CBI..................  (G) The           (G) 2-propenoic
                                                                               anticipated use   acid, polymer
                                                                               is as a pigment   with N-(alkyl)-
                                                                               dispersant.       2propenamide,
                                                                                sodium alkyl
                                                                                alkene
                                                                                sulfonate (1:1)
                                                                                and sodium 2-
                                                                                methyl-2-[(1-
                                                                                oxo-2-propen-1-
                                                                                yl) amino]-1-
                                                                                propanesulfonat
                                                                                e (1:1),
                                                                                ammonium salt,
                                                                                peroxydisulfuri
                                                                                c acid
                                                                                ([(ho)s(o)2]2o2
                                                                                ) sodium salt
                                                                                (1:2)-
                                                                                initiated.
P-16-0523............       9/26/2016      12/25/2016  CBI..................  (G) As described  (G) 2-propenoic
                                                                               above, the        acid, polymer
                                                                               notified          with N-(alkyl)-
                                                                               polymer will be   2propenamide,
                                                                               use as a          sodium alkyl
                                                                               pigment           alkene
                                                                               dispersant.       sulfonate (1:1)
                                                                                and sodium 2-
                                                                                methyl-2-[(1-
                                                                                oxo-2-propen-1-
                                                                                yl) amino]-1-
                                                                                propanesulfonat
                                                                                e (1:1),
                                                                                ammonium salt,
                                                                                peroxydisulfuri
                                                                                c acid
                                                                                ([(ho)s(o)2]2o2
                                                                                ) sodium salt
                                                                                (1:2)-
                                                                                initiated.
P-16-0523............       9/26/2016      12/25/2016  CBI..................  (G) The           (G) 2-propenoic
                                                                               anticipated use   acid, polymer
                                                                               is as a deposit   with N-(alkyl)-
                                                                               control agent.    2propenamide,
                                                                                sodium alkyl
                                                                                alkene
                                                                                sulfonate (1:1)
                                                                                and sodium 2-
                                                                                methyl-2-[(1-
                                                                                oxo-2-propen-1-
                                                                                yl) amino]-1-
                                                                                propanesulfonat
                                                                                e (1:1),
                                                                                ammonium salt,
                                                                                peroxydisulfuri
                                                                                c acid
                                                                                ([(ho)s(o)2]2o2
                                                                                ) sodium salt
                                                                                (1:2)-
                                                                                initiated.
P-16-0523............       9/26/2016      12/25/2016  CBI..................  (G) The           (G) 2-propenoic
                                                                               anticipated use   acid, polymer
                                                                               is as a deposit   with N-(alkyl)-
                                                                               control agent     2propenamide,
                                                                               and pigment       sodium alkyl
                                                                               dispersant.       alkene
                                                                                sulfonate (1:1)
                                                                                and sodium 2-
                                                                                methyl-2-[(1-
                                                                                oxo-2-propen-1-
                                                                                yl) amino]-1-
                                                                                propanesulfonat
                                                                                e (1:1),
                                                                                ammonium salt,
                                                                                peroxydisulfuri
                                                                                c acid
                                                                                ([(ho)s(o)2]2o2
                                                                                ) sodium salt
                                                                                (1:2)-
                                                                                initiated.
P-16-0528............       9/14/2016      12/13/2016  Shell Chemical LP....  (S) Metal         (S)
                                                                               workings fluids/  Hydrocarbons,
                                                                               rolling oils.     C16	22,
                                                                                branched and
                                                                                linear.
P-16-0528............       9/14/2016      12/13/2016  Shell Chemical LP....  (S) Coatings....  (S)
                                                                                Hydrocarbons,
                                                                                C16	22,
                                                                                branched and
                                                                                linear.
P-16-0528............       9/14/2016      12/13/2016  Shell Chemical LP....  (S)               (S)
                                                                               Agrochemicals.    Hydrocarbons,
                                                                                C16	22,
                                                                                branched and
                                                                                linear.
P-16-0528............       9/14/2016      12/13/2016  Shell Chemical LP....  (S) Cleaning      (S)
                                                                               fluids.           Hydrocarbons,
                                                                                C16	22,
                                                                                branched and
                                                                                linear.
P-16-0528............       9/14/2016      12/13/2016  Shell Chemical LP....  (S) Sold as       (S)
                                                                               intermediate.     Hydrocarbons,
                                                                                C16	22,
                                                                                branched and
                                                                                linear.
P-16-0537............       9/21/2016      12/20/2016  CBI..................  (G) Masking       (G) Formaldehyde
                                                                               photopolymer.     phenol
                                                                                isobenzofurandi
                                                                                one polymer.
P-16-0540............       9/28/2016      12/27/2016  CBI..................  (G) Polymeric     (G) Diphenolic
                                                                               film former for   compound,
                                                                               coatings.         polymer with 2-
                                                                                (chloromethyl)o
                                                                                xirane and 4,4'-
                                                                                methylenebis[di-
                                                                                alkyl-
                                                                                substituted
                                                                                phenol].
P-16-0541............       9/19/2016      12/18/2016  Specialty Organics,    (S) Adhesive for  (S) Soybean
                                                        Inc..                  wood particle/    meal, reaction
                                                                               chip/fiberboard.  products with
                                                                                phosphoric
                                                                                trichloride.
P-16-0545............        9/2/2016       12/1/2016  CBI..................  (G) Device        (G) Substituted
                                                                               chemical.         siloxane
                                                                                polymer.
P-16-0546............       9/16/2016      12/15/2016  Cardolite Corporation  (S) GX-9203 is    (G) Cashew,
                                                                               used for the      nutshell
                                                                               adhesive          liquid, polymer
                                                                               application.      with acid and
                                                                                halohydrin.
P-16-0547............        9/6/2016       12/5/2016  CBI..................  (G) Catalyst....  (G) Neodymium
                                                                                aluminum alkyl
                                                                                catalyst.
P-16-0548............        9/8/2016       12/7/2016  CBI..................  (G) Resin         (G)
                                                                               catalyst.         Triarylsulfoniu
                                                                                m salt.
P-16-0570............       9/21/2016      12/20/2016  CBI..................  (S) Aromatic      (G) Aromatic
                                                                               polyester         polyester
                                                                               polyol for        polyol.
                                                                               rigid foam.
P-16-0571............       9/14/2016      12/13/2016  CBI..................  (G) Additive for  (G) Alkyl
                                                                               coatings.         alkenoate,
                                                                                alkanediyl,
                                                                                polymer with
                                                                                alkyl
                                                                                alkenoate,
                                                                                substituted
                                                                                carbomonocycle,
                                                                                alkyl alkenoate
                                                                                and
                                                                                heteromonocycle
                                                                                alkyl
                                                                                alkenoate,
                                                                                diazene bis
                                                                                alkyl
                                                                                heteromonocycle
                                                                                initiated.

P-16-0572............       9/14/2016      12/13/2016  Hexion Inc...........  (S) Tackifier in  (G) Polyamine
                                                                               hot melt          polyacid
                                                                               adhesive and      adducts.
                                                                               pressure
                                                                               sensitive
                                                                               adhesive
                                                                               formulation.
P-16-0572............       9/14/2016      12/13/2016  Hexion Inc...........  (G) Adhesive      (G) Polyamine
                                                                               ingredient.       polyacid
                                                                                adducts.
P-16-0572............       9/14/2016      12/13/2016  Hexion Inc...........  (G) Adhesive for  (G) Polyamine
                                                                               coating.          polyacid
                                                                                adducts.
P-16-0572............       9/14/2016      12/13/2016  Hexion Inc...........  (G) Adhesive for  (G) Polyamine
                                                                               coating           polyacid
                                                                               particulate       adducts.
                                                                               materials.
P-16-0573............       9/14/2016      12/13/2016  Hexion Inc...........  (G) Adhesive      (G) Polyamine
                                                                               ingredient.       polyacid
                                                                                adducts.
P-16-0573............       9/14/2016      12/13/2016  Hexion Inc...........  (S) Tackifier in  (G) Polyamine
                                                                               hot melt          polyacid
                                                                               adhesive and      adducts.
                                                                               pressure
                                                                               sensitive
                                                                               adhesive
                                                                               formulation.
P-16-0573............       9/14/2016      12/13/2016  Hexion Inc...........  (G) Adhesive for  (G) Polyamine
                                                                               coating           polyacid
                                                                               particulate       adducts.
                                                                               materials.
P-16-0573............       9/14/2016      12/13/2016  Hexion Inc...........  (G) Adhesive for  (G) Polyamine
                                                                               coating.          polyacid
                                                                                adducts.
P-16-0575............       9/15/2016      12/14/2016  CBI..................  (S)               (S)
                                                                               Polymerization    Glucosyltransfe
                                                                               of glucose.       rase--the CASRN
                                                                                was determined
                                                                                using the
                                                                                international
                                                                                union of
                                                                                biochemistry
                                                                                and molecular
                                                                                biology (iubmb)
                                                                                enzyme
                                                                                nomenclature
                                                                                recommendations
                                                                                for the noticed
                                                                                enzyme (see
                                                                                attachment--iub
                                                                                mb
                                                                                nomenclature).
                                                                                reaction
                                                                                catalyzed:
                                                                                sucrose+[(1--
                                                                                >6)-?-d-
                                                                                glucosyl]n = d-
                                                                                fructose + [(1--
                                                                                >6)-?-d-
                                                                                glucosyl]n+1iub
                                                                                mb number:
                                                                                <IP_ADDRESS> in
                                                                                addition to
                                                                                catalyzing the
                                                                                formation of
                                                                                alpha-1-6-
                                                                                glucan linkages
                                                                                as specified in
                                                                                the iubmb
                                                                                number <IP_ADDRESS>,
                                                                                depending on
                                                                                the source
                                                                                organism and
                                                                                gene, the
                                                                                glycosyltransfe
                                                                                rase enzyme may
                                                                                catalyze other
                                                                                alpha linkages
                                                                                including alpha
                                                                                1-3 for the
                                                                                noticed enzyme
                                                                                and other
                                                                                linkages (e.g.
                                                                                1,4-, 1,6-).
P-16-0576............       9/16/2016      12/15/2016  CBI..................  (G) Intermediate  (G) Modified
                                                                                alkyl
                                                                                polyamine.
P-16-0577............       9/16/2016      12/15/2016  CBI..................  (G) Oil           (G) Alkyl
                                                                               lubricant         polyamine.
                                                                               additive.
P-16-0579............       9/19/2016      12/18/2016  Allnex USA Inc.......  (S) Ultraviolet   (G) Waste
                                                                               (uv) curable      plastics,
                                                                               coating resin.    poly(ethylene
                                                                                terephthalate),
                                                                                depolymd. with
                                                                                polypropylene
                                                                                glycol ether
                                                                                with glycerol
                                                                                (3:1), polymers
                                                                                with alkenoic
                                                                                and alkanoic
                                                                                acids.
P-16-0580............       9/19/2016      12/18/2016  CBI..................  (G) Synthetic     (G)
                                                                               aircraft engine   Trimethylolprop
                                                                               lubricant for     ane ester of
                                                                               contained use     mixed linear
                                                                               industrial        and branched
                                                                               lubricant.        carboxylic
                                                                                acids.
P-16-0581............       9/19/2016      12/18/2016  CBI..................  (S) Polymer       (G)
                                                                               additive.         Polysaccharide.
P-16-0581............       9/19/2016      12/18/2016  CBI..................  (S) Fiber         (G)
                                                                               additive.         Polysaccharide.
P-16-0581............       9/19/2016      12/18/2016  CBI..................  (S) Composite     (G)
                                                                               component.        Polysaccharide.
P-16-0581............       9/19/2016      12/18/2016  CBI..................  (S) Paper         (G)
                                                                               coating           Polysaccharide.
                                                                               component.
P-16-0582............       9/20/2016      12/19/2016  CBI..................  (S) Lubricity     (G) Carboxylic
                                                                               additive for      acids,
                                                                               industrial oils   polyalkyl
                                                                               And other         unsaturated,
                                                                               lubricants.       oligomers,
                                                                                polymers with
                                                                                substituted
                                                                                alkyl alkenol
                                                                                and
                                                                                alkylpolyol.
P-16-0582............       9/20/2016      12/19/2016  CBI..................  (S) Lubricity     (G) Carboxylic
                                                                               additive for      acids,
                                                                               automotive        polyalkyl
                                                                               engine oil.       unsaturated,
                                                                                oligomers,
                                                                                polymers with
                                                                                substituted
                                                                                alkyl alkenol
                                                                                and
                                                                                alkylpolyol.
P-16-0583............       9/21/2016      12/20/2016  CBI..................  (S) Sealant for   (G) Aromatic
                                                                               head lamps of     hydrocarbon
                                                                               cars.             resin.
P-16-0584............       9/22/2016      12/21/2016  CBI..................  (G) Additive      (G) Multi-walled
                                                                               used to impart    carbon
                                                                               specific          nanotubes.
                                                                               physicochemical
                                                                               property(ies)
                                                                               to finished
                                                                               articles.
P-16-0585............       9/22/2016      12/21/2016  CBI..................  (G) Additive      (G) Multi-walled
                                                                               used to impart    carbon
                                                                               specific          nanotubes.
                                                                               physicochemical
                                                                               property(ies)
                                                                               to finished
                                                                               articles.
P-16-0586............       9/22/2016      12/21/2016  CBI..................  (G) Additive      (G) Muti-walled
                                                                               used to impart    carbon
                                                                               specific          nanotubes.
                                                                               physicochemical
                                                                               property(ies)
                                                                               to finished
                                                                               articles.
P-16-0587............       9/22/2016      12/21/2016  Kemira Chemicals.....  (S) Flocculant    (S)
                                                                               used in iron      Galactoarabinox
                                                                               ore processing    ylan.
                                                                               plant.

P-16-0588............       9/22/2016      12/21/2016  CBI..................  (G) Additive for  (G) Alkyl
                                                                               coatings.         methacrylate,
                                                                                polymer with
                                                                                alkyl acrylate
                                                                                and polyesters.
P-16-0589............       9/22/2016      12/21/2016  CBI..................  (G) Synthetic     (G)
                                                                               aircraft engine   Pentaerythritol
                                                                               lubricant for     ester of mixed
                                                                               contained use     linear and
                                                                               industrial        branched
                                                                               lubricant.        carboxylic
                                                                                acids.
P-16-0593............       9/28/2016      12/27/2016  CBI..................  (S) Aromatic      (G) Aromatic
                                                                               polyester         polyester
                                                                               polyol for        polyol.
                                                                               rigid foam.
P-16-0594............       9/28/2016      12/27/2016  Chitec Technology      (G) Ink additive  (G) Alkanone,
                                                        Co., Ltd.                                substituted
                                                                                oxyalkyl
                                                                                substituted
                                                                                alkyl
                                                                                carbomonocycle]
                                                                                substituted
                                                                                dialkyl
                                                                                alkylcarbomonoc
                                                                                ycle.
P-16-0595............       9/29/2016      12/28/2016  CBI..................  (G) Polymer.....  (G) Polyether
                                                                                polyurethane.
P-16-0596............       9/29/2016      12/28/2016  Allnex USA Inc.......  (S) Site limited  (G) Alkenoic
                                                                               intermediate      acid, reaction
                                                                               used for          products with
                                                                               production of     polyethylene
                                                                               uv curable        glycol ether
                                                                               coating resin.    with
                                                                                hydroxyalkyl
                                                                                substituted
                                                                                alkane.
----------------------------------------------------------------------------------------------------------------

    For the 21 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 September 1, 2016 to September 30, 2016
----------------------------------------------------------------------------------------------------------------
                                                           Commencement
               Case No.                  Received date         date                       Chemical
----------------------------------------------------------------------------------------------------------------
P-05-0415............................          9/9/2016          9/6/2016  (G) Acrylic polymer with styrene,
                                                                            peroxy-initiated.
P-08-0724............................         9/22/2016         8/23/2016  (G) Cycloaliphatic anhydride, polymer
                                                                            with hydroxy alkyl diol, alkyl
                                                                            ester.
P-11-0012............................          9/1/2016         8/23/2016  (G) Slump retainer in concrete.
P-11-0424............................         9/19/2016         8/25/2016  (G) Alkenoyloxy arylphenone.
P-12-0504............................         9/21/2016         9/20/2016  (G) Phosphinic acid, sodium salt
                                                                            (1:1), reaction products with
                                                                            alkenedioic anhydride homopolymer,
                                                                            sodium salts.
P-13-0948............................          9/9/2016         8/31/2016  (G) Amine phosphate.
P-15-0109............................         9/22/2016         8/28/2016  (S) 1,2,4,5-benzenetetracarboxylic
                                                                            acid, mixed et and me esters,
                                                                            compds. with 4,4'-
                                                                            methylenebis[benzeneamine] mixed et
                                                                            and me 4,4'-carbonylbis[1,2-
                                                                            benzenedicarboxylate].
P-15-0545............................         9/28/2016         9/19/2016  (G) Amine-functional acrylic polymer.
P-15-0660............................         9/14/2016         8/19/2016  (G) Alicyclic anhydride, polymer with
                                                                            alkanepolyol, 2-
                                                                            (chloromethyl)oxirane, 4,4'-(1-
                                                                            methylethylidene)bis[phenol] and
                                                                            cyclic ester.
P-15-0662............................         9/14/2016         8/26/2016  (G) Alicyclic anhydride, polymer with
                                                                            alkanepolyol, 2-
                                                                            (chloromethyl)oxirane, ,
                                                                            alkanediol,4,4'-(1-
                                                                            methylethylidene)bis[phenol] and
                                                                            cyclic ester.
P-15-0693............................          9/2/2016         8/25/2016  (G) 1,2-ethanediamine, N1-(2-
                                                                            aminoethyl)-, reaction products with
                                                                            polyethylenimine and polypropylene
                                                                            glycol -alkyl 3-(5-carboxy-1,3-
                                                                            dihydro-1,3-dioxo-2H-isoindol-2-yl)
                                                                            ethers.
P-15-0704............................          9/6/2016         8/10/2016  (S) Siloxanes and silicones, di-me,
                                                                            [(butylethenylmethylsilyl)oxy]- and
                                                                            hydrogen-terminated.
P-15-0745............................         9/12/2016          9/8/2016  (G) Naturally-occurring minerals,
                                                                            reaction products with boron sodium
                                                                            oxide (b4na2o7), hetero substituted
                                                                            alkyl acrylate polymer, kaolin and
                                                                            sodium silicate.
P-16-0036............................         9/13/2016          8/2/2016  (G) Monohydroxy substituted
                                                                            heteropolycycle.
P-16-0094............................         9/27/2016         9/24/2016  (G) Perfluoropolyether modified
                                                                            organosilane.
P-16-0237............................         9/15/2016         8/20/2016  (S) 2-propenoic acid, dodecyl ester,
                                                                            polymer with 2-hydroxyethyl 2-
                                                                            propenoate.
P-16-0263............................          9/8/2016         8/11/2016  (G) Alkene polymer with anhydride and
                                                                            imides.
P-16-0266............................         9/14/2016          9/8/2016  (G) Polyester polyurethane polyol.
P-16-0272............................          9/9/2016         8/24/2016  (S) Lecithins, soya, hydrogenated.
P-16-0340............................          9/7/2016         8/29/2016  (G) Glycerides, C8	18 and C18
                                                                            unsaturated, from algal
                                                                            fermentation.
P-16-0392............................         9/23/2016          9/6/2016  (S) Soybean oil, mixed with
                                                                            hydrogenated soybean oil,
                                                                            interesterified.
----------------------------------------------------------------------------------------------------------------

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

    Dated: October 27, 2016.
Pamela Myrick,
Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2016-27195 Filed 11-9-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: June 8, 2010 (Volume 75, Number 109)]
[Notices]
[Page 32479-32480]
[DOCID:fr08jn10-104]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2009-E-0165 and FDA-2009-E-0169]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ABLAVAR

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) has determined the
regulatory review period for ABLAVAR (previously the trade name of the
product was VASOVIST) and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of applications to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims the human drug product.

ADDRESSES:  Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product ABLAVAR
(gadofosveset trisodium). ABLAVAR is indicated for use as a contrast
agent in magnetic resonance angiography to evaluate aortoiliac
occlusive disease in adults with known or suspected peripheral vascular
disease. Subsequent to this approval, the Patent and Trademark Office
received patent term restoration applications for ABLAVAR (U.S. Patent
Nos. 6,676,929 and 7,060,250) from Epix Pharmaceuticals, Inc., and the
Patent and Trademark Office requested FDA's assistance in determining
the patents' eligibility for patent term restoration. In a letter dated
September 29, 2009, FDA advised the Patent and Trademark Office that
this human drug product had undergone a regulatory review period and
that the approval of ABLAVAR represented the first permitted commercial
marketing or use of the product. Thereafter, the Patent and Trademark
Office requested that FDA determine the product's regulatory review
period.
    FDA has determined that the applicable regulatory review period for
ABLAVAR is 4,508 days. Of this time, 2,673 days occurred during the
testing phase of the regulatory review period, while 1,835 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective:
August 21, 1996. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on August
21, 1996.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: December 15,
2003. FDA has verified the applicant's claim that the new drug
application (NDA) 21-711 was submitted on December 15, 2003.
    3. The date the application was approved: December 22, 2008. FDA
has verified the applicant's claim that NDA 21-711 was approved on
December 22, 2008.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks 1,806 days of
patent term extension for U.S. Patent No. 6,676,929 and 924 days of
patent term extension for U.S. Patent No. 7,060,250.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by August 9, 2010. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by December 6, 2010. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document.
    Comments and petitions may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 23, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-13655 Filed 6-7-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: May 15, 2008 (Volume 73, Number 95)]
[Notices]
[Page 28186-28188]
[DOCID:fr15my08-110]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-99-5578, FMCSA-99-6156, FMCSA-99-6480, FMCSA-00-7006,
FMCSA-00-7165, FMCSA-04-17195, FMCSA-06-23773, FMCSA-06-24015]

Qualification of Drivers; Exemption Applications; Vision

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

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

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

SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
25 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent
to, or greater than, the level of safety maintained without the
exemptions for these commercial motor vehicle (CMV) drivers.

DATES: This decision is effective June 3, 2008. Comments must be
received on or before June 16, 2008.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-99-5578, FMCSA-99-6156, FMCSA-
99-6480, FMCSA-00-7006, FMCSA-00-7165, FMCSA-04-17195, FMCSA-06-23773,
FMCSA-06-24015, using any of the following methods.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the on-line 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 or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this Notice. Note that DOT posts all comments received without
change to http://www.regulations.gov, including any personal
information included in a comment. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or

postcard or print the acknowledgement page that appears after
submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19476). This information is
also available at http://DocketInfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<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., Monday
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-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 procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 25 individuals who have requested a renewal
of their exemption in accordance with FMCSA procedures. FMCSA has
evaluated these 25 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:

James C. Askin
Paul J. Bannon
Ernie E. Black
Ronnie F. Bowman
Gary O. Brady
Richard J. Cummings
Stephen H. Goldcamp
Steven F. Grass
Wai F. King
Dennis E. Krone
Christopher P. Lefler
William F. Mack
Richard J. McKenzie, Jr.
Christopher J. Meerten
Craig W. Miller
William J. Miller
Robert J. Mohorter
James A. Mohr
Roderick F. Peterson
Tommy L. Ray, Jr.
Ricky L. Shepler
Donald W. Sidwell
Elmer K. Thomas
Raul R. Torres
Richard G. Wendt

    These exemptions are extended subject to the following conditions:
(1) That each individual have a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in 49 CFR 391.41(b)(10), and
(b) by a medical examiner who attests that the individual is otherwise
physically qualified under 49 CFR 391.41; (2) that each individual
provide a copy of the ophthalmologist's or optometrist's report to the
medical examiner at the time of the annual medical examination; and (3)
that each individual provide a copy of the annual medical certification
to the employer for retention in the driver's qualification file and
retain a copy of the certification on his/her person while driving for
presentation to a duly authorized Federal, State, or local enforcement
official. Each exemption will be valid for two 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(e) and
31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 25 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (64 FR 27027; 64 FR 51568; 66 FR 63289; 69 FR 8260; 71 FR
16410; 64 FR 54948; 65 FR 159; 67 FR 10475; 71 FR 26601; 64 FR 68195;
65 FR 20251; 67 FR 38311; 69 FR 26921; 71 FR 27033; 67 FR 17102; 69 FR
17267; 65 FR 20245; 65 FR 57230; 65 FR 33406; 69 FR 17263; 69 FR 31447;
71 FR 6826; 71 FR 19602; 71 FR 14566; 71 FR 30227). Each of these 25
applicants has requested renewal of the exemption and has submitted
evidence showing that the vision in the better eye continues to meet
the standard specified at 49 CFR 391.41(b)(10) and that the vision
impairment is stable. In addition, a review of each record of safety
while driving with the respective vision deficiencies over the past two
years indicates each applicant continues to meet the vision exemption
standards. These factors provide an adequate basis for predicting each
driver's ability to continue to drive safely in interstate commerce.
Therefore, FMCSA concludes that extending the exemption for each
renewal applicant for a period of two years is likely to achieve a
level of safety equal to that existing without the exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by June 16, 2008.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 25 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was based on the merits of each
case and only after careful consideration of the comments received to
its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    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, FMCSA will take immediate steps to revoke the exemption of a
driver.

    Issued on: May 7, 2008.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
 [FR Doc. E8-10824 Filed 5-14-08; 8:45 am]

BILLING CODE 4910-EX-P